The US Food and Drug Administration (FDA) on Monday (Dec 22) approved the first daily pill version of Novo Nordisk’s popular weight loss drug Wegovy, revolutionising the way to treat obesity. The move has also given the drugmaker an edge over its rival Eli Lilly, whose oral drug orforglipron, is still under review. The GLP-1 drug uses the same active ingredient, semaglutide, that powers Wegovy and its sister drug Ozempic, which is used for diabetes.Both Wegovy and Ozempic are widely used as injections. The drug mimics a natural hormone that controls appetite and feelings of fullness. While the FDA had already approved a pill to be used for treating diabetes, the approval of the weight loss drug will allow doctors to prescribe the pill to patients with obesity or those who are overweight with at least one weight-related comorbidity, such as a heart condition, the company said.“With today’s approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection,” Mike Doustdar, president and CEO of Novo Nordisk, said in a statement.According to the US Centers for Disease Control and Prevention (CDC), about 40 per cent of American adults have a prevalence of obesity. The new development was lauded by the US Obesity Care Advocacy Network (OCAN), a nonprofit advocacy group for adults with obesity.“This development represents an important opportunity for people living with obesity, offering an alternative for those hesitant to begin injectable therapy and providing a potentially lower-cost option,” the group said in a statement to AFP.According to Novo Nordisk, the Wegovy pills are expected to be available within weeks. The availability of oral pills could also expand the market for weight loss treatments and reduce costs, CBS reported, citing experts.During a clinical trial, the oral Wegovy resulted in a weight loss of 13.6 per cent of the total body weight of participants in about 15 months, which is nearly the same as injectable Wegovy, with an average weight loss of about 15 per cent.

According to Novo Nordisk, the Wegovy pills are expected to be available within weeks. The availability of oral pills could also expand the market for weight loss treatments and reduce costs

The US Food and Drug Administration (FDA) on Monday (Dec 22) approved the first daily pill version of Novo Nordisk’s popular weight loss drug Wegovy, revolutionising the way to treat obesity. The move has also given the drugmaker an edge over its rival Eli Lilly, whose oral drug orforglipron, is still under review. The GLP-1 drug uses the same active ingredient, semaglutide, that powers Wegovy and its sister drug Ozempic, which is used for diabetes. Both Wegovy and Ozempic are widely used as injections. The drug mimics a natural hormone that controls appetite and feelings of fullness. While the FDA had already approved a pill to be used for treating diabetes, the approval of the weight loss drug will allow doctors to prescribe the pill to patients with obesity or those who are overweight with at least one weight-related comorbidity, such as a heart condition, the company said. “With today’s approval of the Wegovy pill, patients will have a convenient, once-daily pill that can help them lose as much weight as the original Wegovy injection,” Mike Doustdar, president and CEO of Novo Nordisk, said in a statement. According to the US Centers for Disease Control and Prevention (CDC), about 40 per cent of American adults have a prevalence of obesity. The new development was lauded by the US Obesity Care Advocacy Network (OCAN), a nonprofit advocacy group for adults with obesity. “This development represents an important opportunity for people living with obesity, offering an alternative for those hesitant to begin injectable therapy and providing a potentially lower-cost option,” the group said in a statement to AFP. According to Novo Nordisk, the Wegovy pills are expected to be available within weeks. The availability of oral pills could also expand the market for weight loss treatments and reduce costs, CBS reported, citing experts. During a clinical trial, the oral Wegovy resulted in a weight loss of 13.6 per cent of the total body weight of participants in about 15 months, which is nearly the same as injectable Wegovy, with an average weight loss of about 15 per cent.

According to Novo Nordisk, the Wegovy pills are expected to be available within weeks. The availability of oral pills could also expand the market for weight loss treatments and reduce costs.

No injections needed! FDA approves THIS ‘once-daily’ oral weight loss pill – All you need to know

A deadly E. coli outbreak hit 15 US states at the end of last year, leading to one death and over 80 falling sick. However, the Food and Drug Administration (FDA) kept it a secret and did not disclose it to the public, NBC News reported.
In November last year, the outbreak spread across the states, leaving dozens of people sick. It further led to the death of a nine-year-old boy who died of kidney failure.&nbsp;
Also read: <a href="https://www.wionews.com/world/health-crisis-in-uk-over-100-ill-following-e-coli-outbreak-says-ukhsa-729470">Health crisis in UK: Over 100 ill following E coli outbreak, says UKHSA</a>
<h2>What caused the outbreak?</h2>
The deadly E. coli outbreak was linked to romaine lettuce. Also, a 57-year-old woman in Missouri became seriously ill after eating lettuce at a funeral lunch.&nbsp;
According to NBC, the agency did not name the produce company involved in the outbreak and kept it secret, hiding the information from the public.&nbsp;
The investigation was then quietly closed in February 2025, according to an internal report.&nbsp;
Also read: <a href="https://www.wionews.com/world/no-more-food-safety-inspections-in-us-fdas-new-plan-unveiled-amid-massive-staff-cuts-8976954">No more food safety inspections in US? FDA's new plan unveiled amid massive staff cuts</a>
However, while defending itself, the <a href="https://www.wionews.com/world/fda-scientists-told-not-to-use-words-women-disabled-elderly-white-house-calls-it-an-error-8740866">FDA </a>said that it did not release information about the outbreak because by the time it determined the likely source, the contaminated lettuce was no longer available in stores.
"There were no public communications related to this outbreak," the FDA stated in the internal report.
A spokesperson said that the agency only names firms when there is clear evidence and a public health action can be taken.&nbsp;
<h2>People call it 'disturbing'&nbsp;</h2>
After the information went public, some experts reacted to FDA's hidden secret, disagreeing with their decision not to inform the public about the outbreak.&nbsp;
Frank Yiannas, who served as deputy commissioner of food policy at the FDA from 2018 to 2023, called the lack of transparency "disturbing."
"It is disturbing that the FDA hasn't said anything more public or identified the name of a grower or processor," said Yiannas.
"People have a right to know who's selling contaminated products," Sandra Eskin, a former Department of Agriculture official said.&nbsp;
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The deadly E. coli outbreak was linked to romaine lettuce. Also, a 57-year-old woman in Missouri became seriously ill after eating lettuce at a funeral lunch. WORLD

A deadly E. coli outbreak hit 15 US states at the end of last year, leading to one death and over 80 falling sick. However, the Food and Drug Administration (FDA) kept it a secret and did not disclose it to the public, NBC News reported. In November last year, the outbreak spread across the states, leaving dozens of people sick. It further led to the death of a nine-year-old boy who died of kidney failure. Also read: Health crisis in UK: Over 100 ill following E coli outbreak, says UKHSA What caused the outbreak? The deadly E. coli outbreak was linked to romaine lettuce. Also, a 57-year-old woman in Missouri became seriously ill after eating lettuce at a funeral lunch. According to NBC, the agency did not name the produce company involved in the outbreak and kept it secret, hiding the information from the public. The investigation was then quietly closed in February 2025, according to an internal report. Also read: No more food safety inspections in US? FDA's new plan unveiled amid massive staff cuts However, while defending itself, the FDA said that it did not release information about the outbreak because by the time it determined the likely source, the contaminated lettuce was no longer available in stores. "There were no public communications related to this outbreak," the FDA stated in the internal report. A spokesperson said that the agency only names firms when there is clear evidence and a public health action can be taken. People call it 'disturbing' After the information went public, some experts reacted to FDA's hidden secret, disagreeing with their decision not to inform the public about the outbreak. Frank Yiannas, who served as deputy commissioner of food policy at the FDA from 2018 to 2023, called the lack of transparency "disturbing." "It is disturbing that the FDA hasn't said anything more public or identified the name of a grower or processor," said Yiannas. "People have a right to know who's selling contaminated products," Sandra Eskin, a former Department of Agriculture official said. WATCH | US FDA approves first new UTI drug in decades

US government's BIG secret out: FDA kept deadly E. coli outbreak in 15 states hidden. Here's what caused it

The US Food and Drug Administration <a href="https://www.wionews.com/health-and-wellness/fda-issues-highest-risk-warning-for-recalled-chocolates-and-other-related-items-8682952">(FDA)</a>&nbsp;has been making a plan to end most of its routine food safety inspections work amid major staff cuts at the Department of Health and Human Services (HHS), multiple federal health officials told CBS News.&nbsp;
The proficiency testing program of the FDA&rsquo;s Food Emergency Response Network was made to ensure consistency and accuracy across the agency's network of about 170 labs that test food for pathogens.&nbsp;
This comes after 20,000 HHS employees got fired or some departed, leading to disruption in the agency's work on areas including bird flu and drug reviews.&nbsp;
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Meanwhile, US President Donald Trump has been hoping to slash as much as $40 billion from HHS.
&ldquo;Unfortunately, significant reductions in force, including a key quality assurance officer, an analytical chemist, and two microbiologists at FDA&rsquo;s Human Food Program Moffett Center have an immediate and significant impact on the Food Emergency Response Network (FERN) Proficiency Testing (PT) Program,&rdquo; said the email sent on Tuesday from FERN&rsquo;s National Program Office and seen by Reuters.
The program will be suspended at least from September 30. It further means that the agency will be unable to do planned quality-check on food for &nbsp;the parasite cyclospora in spinach or the pesticide glyphosate in barley, among other tests, the email read.&nbsp;
Also read: <a href="https://www.wionews.com/world/fda-scientists-told-not-to-use-words-women-disabled-elderly-white-house-calls-it-an-error-8740866">FDA scientists told not to use words &lsquo;women&rsquo;, &lsquo;disabled&rsquo;, &lsquo;elderly&rsquo;; White House calls it &lsquo;error&rsquo;</a>
&ldquo;These PTs and Exercises are critical to demonstrating the competency and readiness of our laboratory network to detect and respond to food safety and food defense events,&rdquo; it added.
According to CBS report, the FDA plans may need congressional action to fully fund, adding that some higher-risk routine food inspections would probably remain at the FDA.
Notably, in April, the FDA suspended an effort to improve its testing for bird flu in milk, cheese and pet food due to staff shortage.&nbsp;
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This comes after 20,000 HHS employees got fired or some departed, leading to disruption in the agency's work on areas including bird flu and drug reviews. WORLD

The US Food and Drug Administration (FDA) has been making a plan to end most of its routine food safety inspections work amid major staff cuts at the Department of Health and Human Services (HHS), multiple federal health officials told CBS News. The proficiency testing program of the FDA’s Food Emergency Response Network was made to ensure consistency and accuracy across the agency's network of about 170 labs that test food for pathogens. This comes after 20,000 HHS employees got fired or some departed, leading to disruption in the agency's work on areas including bird flu and drug reviews. WATCH |US FDA approves first new UTI drug in decades Meanwhile, US President Donald Trump has been hoping to slash as much as $40 billion from HHS. “Unfortunately, significant reductions in force, including a key quality assurance officer, an analytical chemist, and two microbiologists at FDA’s Human Food Program Moffett Center have an immediate and significant impact on the Food Emergency Response Network (FERN) Proficiency Testing (PT) Program,” said the email sent on Tuesday from FERN’s National Program Office and seen by Reuters. The program will be suspended at least from September 30. It further means that the agency will be unable to do planned quality-check on food for the parasite cyclospora in spinach or the pesticide glyphosate in barley, among other tests, the email read. Also read: FDA scientists told not to use words ‘women’, ‘disabled’, ‘elderly’; White House calls it ‘error’ “These PTs and Exercises are critical to demonstrating the competency and readiness of our laboratory network to detect and respond to food safety and food defense events,” it added. According to CBS report, the FDA plans may need congressional action to fully fund, adding that some higher-risk routine food inspections would probably remain at the FDA. Notably, in April, the FDA suspended an effort to improve its testing for bird flu in milk, cheese and pet food due to staff shortage. Also read: A first of its kind: US FDA-approved nasal spray available for treatment-resistant depression in America

No more food safety inspections in US? FDA's new plan unveiled amid massive staff cuts

As many as 120 people, including men, women, and children, in Mathura district of Uttar Pradesh were admitted to hospitals&nbsp;because of food poisoning, after consuming&nbsp;buckwheat flour, said officials on Tuesday (Aug&nbsp;27).

A special team from the district food and drug administration inspected and sealed the shops of two vendors who were selling contaminated buckwheat flour. A case has been filed against them.

The incident was reported from various villages, with complaints filed in the Farah police area of the Mathura district last night. All the affected persons are stable, as confirmed by the officials.

On the occasion of Janmashtami, many individuals follow the ritual&nbsp;of fasting.&nbsp;Many people experienced vomiting, dizziness, and shivering after eating pooris and pakoras made from buckwheat flour,&nbsp;one of the foods that are consumed during fast.

<h2>Affected individuals&nbsp;</h2>

“We had fritters made from buckwheat flour last night. After that, I started vomiting and felt a burning sensation in my stomach,” said Priyanka, a teenager admitted to the government hospital, according to the PTI video.

Mahesh, another resident, said in the PTI video, “My wife has become very weak, sje was almost unconscious.”

Dr. Bhudev Prasad, head of the health department's rapid response team, said similar instances were reported in several districts.

“Teams from the Health Department, Farah Community Health Centre (CHC), and District Hospital responded swiftly. Initially, patients were treated at the CHC, but as numbers increased, they were moved to the District Hospital, the 100-bed Joint Hospital in Vrindavan, and SN Medical College in Agra,” Dr. Prasad said, as quoted by PTI.

Chief Medical Officer, Dr. Ajay Kumar Verma, asserted that 43 patients were admitted to the SN Medical College Hospital in Agra, 29 to the District Hospital in Mathura, 15 to the 100-bed Combined Hospital, 15 to Baba Jaigurudev Charitable Hospital, 10 to Chauhan Hospital, and others to the CHC in Farah.

“Patients showing improvement today will be discharged,” Dr. Prasad stated.

The affected people are from Parkham, Baroda, Mirzapur, Makhdoom, and Khairat villages. The flour was purchased by Jhagdu and Rajkumar, who supplied it from a grocery merchant in Farah.

(With inputs from agencies)

As many as 120 people, including men, women, and children, in Mathura district of Uttar Pradesh were admitted to hospitals because of food poisoning, after consuming buckwheat flour, said officials on Tuesday (Aug 27).

As many as 120 people, including men, women, and children, in Mathura district of Uttar Pradesh were admitted to hospitals because of food poisoning, after consuming buckwheat flour, said officials on Tuesday (Aug 27). A special team from the district food and drug administration inspected and sealed the shops of two vendors who were selling contaminated buckwheat flour. A case has been filed against them. The incident was reported from various villages, with complaints filed in the Farah police area of the Mathura district last night. All the affected persons are stable, as confirmed by the officials. On the occasion of Janmashtami, many individuals follow the ritual of fasting. Many people experienced vomiting, dizziness, and shivering after eating pooris and pakoras made from buckwheat flour, one of the foods that are consumed during fast. Affected individuals “We had fritters made from buckwheat flour last night. After that, I started vomiting and felt a burning sensation in my stomach,” said Priyanka, a teenager admitted to the government hospital, according to the PTI video. Mahesh, another resident, said in the PTI video, “My wife has become very weak, sje was almost unconscious.” Dr. Bhudev Prasad, head of the health department's rapid response team, said similar instances were reported in several districts. “Teams from the Health Department, Farah Community Health Centre (CHC), and District Hospital responded swiftly. Initially, patients were treated at the CHC, but as numbers increased, they were moved to the District Hospital, the 100-bed Joint Hospital in Vrindavan, and SN Medical College in Agra,” Dr. Prasad said, as quoted by PTI. Chief Medical Officer, Dr. Ajay Kumar Verma, asserted that 43 patients were admitted to the SN Medical College Hospital in Agra, 29 to the District Hospital in Mathura, 15 to the 100-bed Combined Hospital, 15 to Baba Jaigurudev Charitable Hospital, 10 to Chauhan Hospital, and others to the CHC in Farah. “Patients showing improvement today will be discharged,” Dr. Prasad stated. The affected people are from Parkham, Baroda, Mirzapur, Makhdoom, and Khairat villages. The flour was purchased by Jhagdu and Rajkumar, who supplied it from a grocery merchant in Farah. (With inputs from agencies)

120 food poisoning cases reported after consumption of buckwheat flour on Janmashtami

United States Food and Drug Administration, in an online update on Thursday (April 25), said that fragments of the bird flu virus have been detected by federal regulators in around 20 per cent of retail milk samples after they were tested in a nationally representative study.

United States Food and Drug Administration, in an online update on Thursday (April 25), said that fragments of the bird flu virus have been detected by federal regulators in around 20 per cent of retail milk samples after they were tested in a nationally representative study. According to the agency, the samples with high chances of positive test results were collected from different parts of the country and belonged to virus-infected dairy herds. The Food and Drug Administration said that traces of the bird flu virus were found in 1 in 5 samples of pasteurised milk. Also Read: FDA traces fragments of bird flu virus in pasteurised milk, detailed report awaited Till now, bird flu has been found in 33 herds across eight states: Idaho, Kansas, Michigan, New Mexico, North Carolina, South Dakota, Ohio and Texas. No evidence of milk being 'dangerous' for consumers The regulators have again confirmed that till now no evidence has emerged which proves that milk is dangerous for the consumption of the consumers. They added that no presence of live virus has been found in the milk on store shelves. Public health experts have also agreed with the assessment of the regulators. However, traces of the virus in samples of milk from around the country clearly confirm bird flu outbreak in dairy cows. St. Jude Children’s Research Hospital virologist and influenza expert Richard Webby said, “It suggests that there is a whole lot of this virus out there." Watch: Bird Flu Updates: Experts say 'outbreak could be serious' The findings of the FDA emerged less than a month after the H5N1 strain of bird flu was discovered for the first time in dairy cows in several states. Since then, the flu has been detected in herds in eight states. The FDA has been working to investigate the outbreak with the US Department of Agriculture and the Centres for Disease Control and Prevention. The testing method used is called PCR testing and looks for bits of genetic material. If the result is positive, that doesn't mean they have found a live, infectious virus. (With inputs from agencies)

FDA finds traces of bird flu in one in five milk samples across the US

The US Food and Drug Administration (FDA) said on Thursday (Nov 23) that more children in the country were sickened by apple puree pouches that were recently recalled due to lead contamination. According to a report by the news agency Associated Press, the FDA received 52 reports of elevated lead levels among children who reportedly consumed the product, up from 34 cases reported last week.&nbsp;

The cases are spread across 22 states and involve children between the ages of 1 to 4, the FDA said in an update. The puree pouches were marketed under these brands: WanaBana apple cinnamon fruit puree and Schnucks and Weis cinnamon applesauce pouches.

The report said that these products were sold by national grocery chains, including Dollar Tree, and online retailers such as Amazon.

On Thursday, the FDA said that it was still working with Dollar Tree to get the recalled products off of shelves in several states.&nbsp;

“This product should not be available for sale and consumers should not purchase or consume this product,” the agency further said and advised parents to dispose of the pouches by emptying the contents into the trash and discarding the packaging.&nbsp;

Exposure to lead can lead to serious learning, cognitive and behavioural problems. The American Academy of Pediatrics, meanwhile, has said that heavy metals like lead can get into food products from soil, air, water or industrial processes.&nbsp;

Nearly a week back, the FDA announced it was screening imports of cinnamon from multiple countries for toxic lead contamination as children were falling sick after consuming apple puree and apple sauce pouches.

The FDA said that cinnamon from a manufacturer in Ecuador was the likely source of high levels of lead found in recalled pouches linked to illnesses in the 34 cases earlier reported.

Officials told the Associated Press that one pouch of WanaBana apple cinnamon puree collected from a Dollar Tree store was found to have lead levels more than 200 times higher than proposed FDA guidance would allow.&nbsp;

(With inputs from agencies)

The US Food and Drug Administration (FDA) said on Thursday (Nov 23) that more children in the country were sickened by apple puree pouches that were recently recalled due to lead contamination.

The US Food and Drug Administration (FDA) said on Thursday (Nov 23) that more children in the country were sickened by apple puree pouches that were recently recalled due to lead contamination. According to a report by the news agency Associated Press, the FDA received 52 reports of elevated lead levels among children who reportedly consumed the product, up from 34 cases reported last week. The cases are spread across 22 states and involve children between the ages of 1 to 4, the FDA said in an update. The puree pouches were marketed under these brands: WanaBana apple cinnamon fruit puree and Schnucks and Weis cinnamon applesauce pouches. The report said that these products were sold by national grocery chains, including Dollar Tree, and online retailers such as Amazon. On Thursday, the FDA said that it was still working with Dollar Tree to get the recalled products off of shelves in several states. “This product should not be available for sale and consumers should not purchase or consume this product,” the agency further said and advised parents to dispose of the pouches by emptying the contents into the trash and discarding the packaging. Exposure to lead can lead to serious learning, cognitive and behavioural problems. The American Academy of Pediatrics, meanwhile, has said that heavy metals like lead can get into food products from soil, air, water or industrial processes. Nearly a week back, the FDA announced it was screening imports of cinnamon from multiple countries for toxic lead contamination as children were falling sick after consuming apple puree and apple sauce pouches. The FDA said that cinnamon from a manufacturer in Ecuador was the likely source of high levels of lead found in recalled pouches linked to illnesses in the 34 cases earlier reported. Officials told the Associated Press that one pouch of WanaBana apple cinnamon puree collected from a Dollar Tree store was found to have lead levels more than 200 times higher than proposed FDA guidance would allow. (With inputs from agencies)

US: 52 more children sickened by fruit pouches tainted by lead, says FDA

Phenylephrine, the famous decongestant used for relief from&nbsp;stuffy nose by millions of Americans is nothing better than a dummy pill, as per government experts.

They had reviewed the latest research on the long-questioned drug ingredient in versions of Sudafed, Allegra, Dayquil and other medications which remain stocked on store shelves. 
 
On Tuesday, the Food and Drug Administration's advisers unanimously voted against the ingredient's effectiveness. 
 
“Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” stated Dr. Mark Dykewicz, who works as an allergy specialist at the Saint Louis University School of Medicine, reported AP.

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The FDA's outside advisers assembled to reassess phenylephrine, which emerged as the main drug in over-the-counter decongestants after medicines with an older ingredient, known as pseudoephedrine, went behind pharmacy counters.

<h2>Oral medications likely to be pulled down from store shelves</h2>

If the recommendations of the panel are followed by the FDA, drug makers like Bayer, Johnson &amp; Johnson and others will need to pull their oral medications, which contain phenylephrine, from store shelves. 
 
This is likely to force consumers to go for the behind-the-counter pills or drops and nasal sprays, which contain phenylephrine and are not under review. 
 
The panelists on Tuesday said that in that scenario, the FDA will have to work with pharmacists, drugstores and other health providers to inform consumers about the remaining options they have for treating congestion. 
 
The advisers also informed the FDA that understanding phenylephrine at higher doses was not an option because it increase blood pressure to dangerous levels. 
 
“I think there’s a safety issue there,” stated Dr. Paul Pisaric of Archwell Health in Oklahoma. “I think this is a done deal as far as I’m concerned. It doesn’t work,” he added.

WATCH |&nbsp;US FDA approves updated Covid-19 booster shots

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The two-day meeting, which was held this week, was organised by the researchers of the University of Florida who petitioned the FDA to remove phenylephrine products on the basis of recent studies which showed they did not outperform placebo pills in patients, suffering from cold and allergy congestion. 
 
A patient representative on the panel Jennifer Schwartzott said, “I feel this drug in this oral dose should have been removed from the market a long time ago. Patients require and deserve medications that treat their symptoms safely and effectively and I don’t believe that this medication does that.”&nbsp;

You can&nbsp;now write for&nbsp;wionews.com&nbsp;and be a part of the community. Share your stories and opinions with us&nbsp;<a href="https://www.wionews.com/content-contribution-registration-form">here</a>.

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Phenylephrine, the famous decongestant used for relief from stuffy nose by millions of Americans is nothing better than a dummy pill, as per government experts. They had reviewed the latest research on the long-questioned drug ingredient in versions of Sudafed, Allegra, Dayquil and other medications which remain stocked on store shelves.

Phenylephrine, the famous decongestant used for relief from stuffy nose by millions of Americans is nothing better than a dummy pill, as per government experts. They had reviewed the latest research on the long-questioned drug ingredient in versions of Sudafed, Allegra, Dayquil and other medications which remain stocked on store shelves. On Tuesday, the Food and Drug Administration's advisers unanimously voted against the ingredient's effectiveness. “Modern studies, when well conducted, are not showing any improvement in congestion with phenylephrine,” stated Dr. Mark Dykewicz, who works as an allergy specialist at the Saint Louis University School of Medicine, reported AP. ALSO READ | Pfizer therapy for hard-to-treat blood cancer granted FDA accelerated approval The FDA's outside advisers assembled to reassess phenylephrine, which emerged as the main drug in over-the-counter decongestants after medicines with an older ingredient, known as pseudoephedrine, went behind pharmacy counters. Oral medications likely to be pulled down from store shelves If the recommendations of the panel are followed by the FDA, drug makers like Bayer, Johnson & Johnson and others will need to pull their oral medications, which contain phenylephrine, from store shelves. This is likely to force consumers to go for the behind-the-counter pills or drops and nasal sprays, which contain phenylephrine and are not under review. The panelists on Tuesday said that in that scenario, the FDA will have to work with pharmacists, drugstores and other health providers to inform consumers about the remaining options they have for treating congestion. The advisers also informed the FDA that understanding phenylephrine at higher doses was not an option because it increase blood pressure to dangerous levels. “I think there’s a safety issue there,” stated Dr. Paul Pisaric of Archwell Health in Oklahoma. “I think this is a done deal as far as I’m concerned. It doesn’t work,” he added. WATCH | US FDA approves updated Covid-19 booster shots The two-day meeting, which was held this week, was organised by the researchers of the University of Florida who petitioned the FDA to remove phenylephrine products on the basis of recent studies which showed they did not outperform placebo pills in patients, suffering from cold and allergy congestion. A patient representative on the panel Jennifer Schwartzott said, “I feel this drug in this oral dose should have been removed from the market a long time ago. Patients require and deserve medications that treat their symptoms safely and effectively and I don’t believe that this medication does that.” You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here. WATCH WION LIVE HERE

'Dummy pill': Popular nasal decongestant fails in relieving congestion, claims FDA

An independent advisory committee to the Food and Drug Administration (FDA) on Thursday voted to recommend a vaccination shot for pregnant mothers which can protect their infants from RSV. 
 
The shot, made by Pfizer, was unanimously recommended by the 14-person panel based on its efficacy as they voted 10-4 to recommend it on the basis of its safety. 
 
If the FDA eventually approves the shot, then it would become the first vaccine that confers protection to babies against respiratory syncytial virus. 
 
Boston Children’s Hospital's Director of the Precision Vaccines Programme Dr Ofer Levy said, “Before the pandemic, RSV was the No. 1 cause of infant hospitalisation in the United States, so this is a big deal.” Levy is FDA's temporary voting member and did not participate in Thursday’s voting.

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Lower respiratory illness which is caused by RSV in healthy adults is generally mid but it can be severe in older adults and babies. Around 300 children stand the risk of losing their lives in five years in the US because of the virus, as per to the Centres for Disease Control and Prevention. 
 
Severe infections can lead to bronchiolitis or pneumonia because of which airways are inflamed and clogged with mucus. 
 
The FDA can take months to approve the shot, but the agency will most probably follow the recommendations of the advisory committee.

<h2> 
 
GSK halts trial of RSV vaccine 
&nbsp;</h2>

Pharmaceutical giant GSK last week halted the trial of the RSV vaccine for infants after a higher preterm birth rate was seen in some vaccine recipients. 
 
FDA advisory committee member and director of the Vaccine Education Center at Children’s Hospital of Philadelphia Dr Paul Offit said that the outcome of GSK’s trial was relevant to the study of Pfizer, since both the vaccines are similar. 
 
“I worry that if preterm births are in any way a consequence of this vaccine, that would be tragic in many ways,” said Offit at Thursday’s meeting. He voted against the proposed shot on the basis of its safety.

WATCH |&nbsp;Gravitas Plus: Gen Z prone to heart attacks, diabetes?

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Levy stated that close attention is paid by researchers generally to any potential risk of preterm birth among vaccines which are given to pregnant women. 
 
“There’s always the background concern: Are you inducing some inflammation that could be a problem? Because the body reads inflammation as ‘the woman’s no longer safe, let’s get the baby out.’ So you want a fairly bland vaccine,” he stated.

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An independent advisory committee to the Food and Drug Administration (FDA) on Thursday voted to recommend a vaccination shot for pregnant mothers which can protect their infants from RSV.

An independent advisory committee to the Food and Drug Administration (FDA) on Thursday voted to recommend a vaccination shot for pregnant mothers which can protect their infants from RSV. The shot, made by Pfizer, was unanimously recommended by the 14-person panel based on its efficacy as they voted 10-4 to recommend it on the basis of its safety. If the FDA eventually approves the shot, then it would become the first vaccine that confers protection to babies against respiratory syncytial virus. Boston Children’s Hospital's Director of the Precision Vaccines Programme Dr Ofer Levy said, “Before the pandemic, RSV was the No. 1 cause of infant hospitalisation in the United States, so this is a big deal.” Levy is FDA's temporary voting member and did not participate in Thursday’s voting. ALSO READ | Alzheimer's disease slowed down by a third with this new breakthrough medicine Lower respiratory illness which is caused by RSV in healthy adults is generally mid but it can be severe in older adults and babies. Around 300 children stand the risk of losing their lives in five years in the US because of the virus, as per to the Centres for Disease Control and Prevention. Severe infections can lead to bronchiolitis or pneumonia because of which airways are inflamed and clogged with mucus. The FDA can take months to approve the shot, but the agency will most probably follow the recommendations of the advisory committee. GSK halts trial of RSV vaccine Pharmaceutical giant GSK last week halted the trial of the RSV vaccine for infants after a higher preterm birth rate was seen in some vaccine recipients. FDA advisory committee member and director of the Vaccine Education Center at Children’s Hospital of Philadelphia Dr Paul Offit said that the outcome of GSK’s trial was relevant to the study of Pfizer, since both the vaccines are similar. “I worry that if preterm births are in any way a consequence of this vaccine, that would be tragic in many ways,” said Offit at Thursday’s meeting. He voted against the proposed shot on the basis of its safety. WATCH | Gravitas Plus: Gen Z prone to heart attacks, diabetes? Levy stated that close attention is paid by researchers generally to any potential risk of preterm birth among vaccines which are given to pregnant women. “There’s always the background concern: Are you inducing some inflammation that could be a problem? Because the body reads inflammation as ‘the woman’s no longer safe, let’s get the baby out.’ So you want a fairly bland vaccine,” he stated. You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here. WATCH WION LIVE HERE

FDA panel recommends jab for pregnant mothers to prevent RSV in infants

The US Food and Drug Administration (FDA) on Friday approved an experimental medicine named lecanemab for Alzheimer's treatment. FDA Director Dr Billy Dunn in a statement said the medicine targets the underlying disease process of Alzheimer's instead of treating the symptoms only.

The US Food and Drug Administration (FDA) on Friday approved an experimental medicine named lecanemab for Alzheimer's treatment. FDA Director Dr Billy Dunn in a statement said the medicine targets the underlying disease process of Alzheimer's instead of treating the symptoms only. “Alzheimer’s disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones. This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s, instead of only treating the symptoms of the disease.” Japan-based Eisai and American company Biogen have jointly developed the medicine. They claim that lecanemab slows down cognitive and functional decline by almost 27 per cent over 18 months. The medicine will be sold under the name Leqembi and its treatment is expected to cost $26,500 per year in the US. The clinical trials of the medicine were published in November last year. Based on the results, some experts hailed it as the next big breakthrough to treat Alzheimer's patients. WATCH | Gravitas: Breakthrough in Alzheimer's treatment × “Treatments that deliver tangible benefits to those living with mild cognitive impairment (MCI) due to Alzheimer’s and early Alzheimer’s dementia are as valuable as treatments that extend the lives of those with other terminal diseases," said US-based Alzheimer’s Association whilst welcoming the test results. Notably, the approval process for Leqembi was expedited after a US congressional report tore into the regulatory agency for approving another Alzheimer's medicine viz. Aduhelm, without proper due diligence. Read more: Experimental drug slows down cognitive decline in Alzheimer's patients: Here’s what you need to know Despite test results showing that Aduhelm carried risks of brain swelling and bleeding when administered to patients, the FDA passed it for monoclonal antibody treatment. The FDA has the authority to fast-track the medicines it believes can help patients suffering from serious conditions. Currently, over 6.5 million individuals in the US suffer from Alzheimer's disease. The disease destroys memory, and cognitive skills, often rendering the patient incapable of performing simple, day-to-day tasks. Though there is no cure for the disease, doctors say that treatment therapies and medicines can slow down the effects. (With inputs from agencies) WATCH WION LIVE HERE:

US FDA approves new ‘breakthrough’ medicine for Alzheimer’s. Here’s what it does

For individuals with weak eyes, spectacles and eyeglasses are unquestionably a blessing. They allow you to walk without tripping over objects, read, and essentially just see what's in front of you. But they can also be a curse. It is very easy to forget them at home or in the car, they break easily, and Covid, masks have taught us that they fog up real easy, effectively blinding you. But what if you didn't have to wear those pesky glasses all the time? If you're living in the United States this is a possibility. The FDA (Food and Drug Administration) has recently approved an eye drop that can replace glasses.

Watch |&nbsp;WION Fineprint | US approves eye drops that could replace reading glasses

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This drug is called Vuity and it claims to improve age-related near-vision. As per an Express.co.uk report, the eye drops need to be applied once every six hours and starts working within 15 minutes of application.

According to the report, the medication is a formulated form of the well-known compound known as&nbsp;pilocarpine, and the researchers have developed&nbsp;it to&nbsp;quickly adapt to the pH of the tear film.

Also read |&nbsp;<a href="https://www.wionews.com/world/how-much-alcohol-to-drink-at-what-age-the-lancet-study-reveals-497554" hreflang="en">How much alcohol to drink at what age? The Lancet study reveals</a>

Utilising the eye's natural ability to constrict the pupil, the drop enhances near vision while preserving far vision.

The drop is most helpful for people between the ages of 40 and 55, according to the researchers' analysis of two randomised control trials involving 750 participants.

Moreover, they did not suffer any severe adverse effects; however, a few patients did report minor headaches and eye redness.

(With inputs from agencies)

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For individuals with weak eyes, spectacles and eyeglasses are unquestionably a blessing. They allow you to walk without tripping over objects, read, and essentially just see what's in front of you.

For individuals with weak eyes, spectacles and eyeglasses are unquestionably a blessing. They allow you to walk without tripping over objects, read, and essentially just see what's in front of you. But they can also be a curse. It is very easy to forget them at home or in the car, they break easily, and Covid, masks have taught us that they fog up real easy, effectively blinding you. But what if you didn't have to wear those pesky glasses all the time? If you're living in the United States this is a possibility. The FDA (Food and Drug Administration) has recently approved an eye drop that can replace glasses. Watch | WION Fineprint | US approves eye drops that could replace reading glasses This drug is called Vuity and it claims to improve age-related near-vision. As per an Express.co.uk report, the eye drops need to be applied once every six hours and starts working within 15 minutes of application. According to the report, the medication is a formulated form of the well-known compound known as pilocarpine, and the researchers have developed it to quickly adapt to the pH of the tear film. Also read | How much alcohol to drink at what age? The Lancet study reveals Utilising the eye's natural ability to constrict the pupil, the drop enhances near vision while preserving far vision. The drop is most helpful for people between the ages of 40 and 55, according to the researchers' analysis of two randomised control trials involving 750 participants. Moreover, they did not suffer any severe adverse effects; however, a few patients did report minor headaches and eye redness. (With inputs from agencies) Watch WION LIVE HERE: You can now write for wionews.com and be a part of the community. Share your stories and opinions with us here.

US FDA approves new eye drops that can replace spectacles and fix near-vision

In a first, the United States Food and Drug Administration has approved an oral tablet called baricitinib for the treatment of alopecia.

Alopecia, which is an autoimmune disorder affecting more than 300,000 people in the United States every year, which&nbsp;leads to emotional distress and causes either temporary or permanent patchy hair loss that can affect any hair-bearing site of the body.

Some famous personalities who have been diagnosed with alopecia include Hollywood actress Jada Pinkett Smith and congresswoman Ayanna Pressley.

<a href="https://www.wionews.com/entertainment/lifestyle/news-what-is-alopecia-areata-the-disorder-that-will-smiths-wife-jada-suffers-from-466376">Also read |&nbsp;What is Alopecia Areata? The disorder that Will Smith's wife Jada suffers from</a>

After the approval, FDA official Kendall Marcus in a statement "Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia."

"Today's approval will help fulfill a significant unmet need for patients with severe alopecia areata."

Known by the trade name Olumiant, Baricitinib belongs to a class of drugs called Janus kinase inhibitors and is manufactured by US pharmaceutical company Eli Lilly.

<a href="https://www.wionews.com/world/us-lawmaker-pressley-reveals-baldness-alopecia-diagnosis-274800">Also read |&nbsp;US congresswoman 'Ayanna Pressley' reveals her bald look</a>

The oral tablet, which works by interfering with the cellular pathway that leads to inflammation, was approved for use against alopecia on the basis of on the results of two random clinical trials involving a total of 1,200 adults.

During the clinical trial, participants were split into three groups and almost 40 percent of those on the higher dose grew back 80 percent of their scalp hair after 36 weeks.

Not only this, but approximately 45 percent of people in the higher dose group also saw significant eyebrow and eyelash regrowth.

Baricitinib, which was approved for the treatment of hospitalised Covid patients during the pandemic, is also used for the treatment of rheumatoid arthritis.

(With inputs from agencies)

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In a first, the United States Food and Drug Administration has approved an oral tablet called baricitinib for the treatment of alopecia. Alopecia, which is an autoimmune disorder affecting more than 300,000 people in the United States every year, which leads to emotional distress and causes either temporary or permanent patchy hair loss that can affect any hair-bearing site of the body.

In a first, the United States Food and Drug Administration has approved an oral tablet called baricitinib for the treatment of alopecia. Alopecia, which is an autoimmune disorder affecting more than 300,000 people in the United States every year, which leads to emotional distress and causes either temporary or permanent patchy hair loss that can affect any hair-bearing site of the body. Some famous personalities who have been diagnosed with alopecia include Hollywood actress Jada Pinkett Smith and congresswoman Ayanna Pressley. Also read | What is Alopecia Areata? The disorder that Will Smith's wife Jada suffers from After the approval, FDA official Kendall Marcus in a statement "Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia." "Today's approval will help fulfill a significant unmet need for patients with severe alopecia areata." Known by the trade name Olumiant, Baricitinib belongs to a class of drugs called Janus kinase inhibitors and is manufactured by US pharmaceutical company Eli Lilly. Also read | US congresswoman 'Ayanna Pressley' reveals her bald look The oral tablet, which works by interfering with the cellular pathway that leads to inflammation, was approved for use against alopecia on the basis of on the results of two random clinical trials involving a total of 1,200 adults. During the clinical trial, participants were split into three groups and almost 40 percent of those on the higher dose grew back 80 percent of their scalp hair after 36 weeks. Not only this, but approximately 45 percent of people in the higher dose group also saw significant eyebrow and eyelash regrowth. Baricitinib, which was approved for the treatment of hospitalised Covid patients during the pandemic, is also used for the treatment of rheumatoid arthritis. (With inputs from agencies) Watch WION's live TV here:

US FDA approves first oral tablet called baricitinib for treatment of alopecia

The Food and Drug Administration of the United States may halt cancer drugs and other medicines made in China.

The federal agency of the Department of Health and Human Services has raised concerns about the studies conducted in China. It raised doubts about whether these studies can apply to patients in the United States.

It comes as the FDA is holding an advisory meeting to review the effectiveness of sintilimab used for cancer immunotherapy.

<a href="https://www.wionews.com/world/vaccine-maker-pfizer-faces-accusations-of-pandemic-profiteering-as-profits-double-451591">Also read |&nbsp;Vaccine maker Pfizer faces accusations of 'pandemic profiteering' as profits double</a>

Developed by Eli Lilly and partner Innovent Biologics, the immunotherapy blocks a protein called PD-1, the same as Merck &amp; Co.'s Keytruda and Bristol Myers Squibb's Opdivo.&nbsp;

Lilly's application has become a test of the regulator's views on cancer treatments developed and tested exclusively in China.&nbsp;

A handful of companies are using that blueprint in an attempt to speed new therapies to the US market, raising concerns from some of the agency's top cancer drug evaluators.

Previously, the FDA had approved BeiGene Ltd’s lymphoma treatment, validating the China-based drugmaker’s strategy of largely using data from trials held outside the United States to file for approval.

<a href="https://www.wionews.com/world/to-boost-defences-against-aggressive-china-us-approves-100-million-support-deal-with-taiwan-451360">Also read |&nbsp;To boost defences against aggressive China, US approves $100 million support deal with Taiwan</a>

BeiGene’s treatment is competing with Johnson &amp; Johnson and AbbVie Inc’s Imbruvica and AstraZeneca’s Calquence, as well as Celgene’s Revlimid.

Analysts believe one of the biggest national security threats in the US-China trade war could be to the everyday medicines taken by millions of Americans.

The US&nbsp;relies on imported medicines from China in a big way. Antibiotics, over-the-counter pain meds and the stuff that stops itching and swelling — a lot of it is imported from China.

Former US President Donald Trump had left pharmaceuticals out of the bilateral trade war. He had used national security as a rationale to slap tariffs or trade sanctions on a variety of imports but medical supplies were not scrutinised.

“Medicines can be used as a weapon of war against the United States,” Rosemary Gibson, a senior adviser on health care issues at the bioethics-focused Hastings Centre and co-author of “China Rx: Exposing the Risks of America's Dependence on China for Medicine,” told lawmakers last month.&nbsp;

“Supplies can be withheld. Medicines can be made with lethal contaminants or sold without any real medicine in them, rendering them ineffective.”

(With inputs from agencies)

The Food and Drug Administration of the United States may halt cancer drugs and other medicines made in China. The federal agency of the Department of Health and Human Services has raised concerns about the studies conducted in China.

The Food and Drug Administration of the United States may halt cancer drugs and other medicines made in China. The federal agency of the Department of Health and Human Services has raised concerns about the studies conducted in China. It raised doubts about whether these studies can apply to patients in the United States. It comes as the FDA is holding an advisory meeting to review the effectiveness of sintilimab used for cancer immunotherapy. Also read | Vaccine maker Pfizer faces accusations of 'pandemic profiteering' as profits double Developed by Eli Lilly and partner Innovent Biologics, the immunotherapy blocks a protein called PD-1, the same as Merck & Co.'s Keytruda and Bristol Myers Squibb's Opdivo. Lilly's application has become a test of the regulator's views on cancer treatments developed and tested exclusively in China. A handful of companies are using that blueprint in an attempt to speed new therapies to the US market, raising concerns from some of the agency's top cancer drug evaluators. Previously, the FDA had approved BeiGene Ltd’s lymphoma treatment, validating the China-based drugmaker’s strategy of largely using data from trials held outside the United States to file for approval. Also read | To boost defences against aggressive China, US approves $100 million support deal with Taiwan BeiGene’s treatment is competing with Johnson & Johnson and AbbVie Inc’s Imbruvica and AstraZeneca’s Calquence, as well as Celgene’s Revlimid. Analysts believe one of the biggest national security threats in the US-China trade war could be to the everyday medicines taken by millions of Americans. The US relies on imported medicines from China in a big way. Antibiotics, over-the-counter pain meds and the stuff that stops itching and swelling — a lot of it is imported from China. Former US President Donald Trump had left pharmaceuticals out of the bilateral trade war. He had used national security as a rationale to slap tariffs or trade sanctions on a variety of imports but medical supplies were not scrutinised. “Medicines can be used as a weapon of war against the United States,” Rosemary Gibson, a senior adviser on health care issues at the bioethics-focused Hastings Centre and co-author of “China Rx: Exposing the Risks of America's Dependence on China for Medicine,” told lawmakers last month. “Supplies can be withheld. Medicines can be made with lethal contaminants or sold without any real medicine in them, rendering them ineffective.” (With inputs from agencies)

United States: FDA poised to tap brakes on China-made cancer drugs

The pandemic has caused many supply-chain bottlenecks in everyday life, but few are as critical as the United States’ ever-shrinking blood banks. For the American Red Cross, which supplies about 40% of the nation’s blood, and other nonprofit blood centers, the problem lies mostly at the top of the chain: the diminishing number of healthy donors.

“This is the biggest challenge that I’ve seen in my 30 years in the business,” Chris Hrouda, president of biomedical services at the American Red Cross, said in an interview Thursday.

Donations of blood typically decline at this time of year, when holiday parties, wintry weather, seasonal illnesses, travel, and school and college breaks lead to lower donor turnout. But Hrouda said this month’s national supply had dipped to levels that the Red Cross has not seen in 10 years.

“We simply like to keep three days of inventory,” he said. “We’re struggling to keep one day.” Blood takes up to three days to be tested and prepared for patients.

Remote work, blood drive cancellations, and the limits that colleges and businesses have placed on the number of people allowed in public spaces have all reduced donor turnout.

“We just didn’t get as much access as we had hoped for this fall,” Hrouda said.

Compounding the problem, the Red Cross, like many employers, is struggling to attract and retain employees amid the pandemic.

The critical shortage leaves hospitals to more carefully allocate the precious resource. “We have not had to delay any cases yet, but we are very mindful" of what our blood supply is, said Dr. Jennifer Andrews, medical director of the Vanderbilt University Medical Center blood bank in Nashville, Tennessee. Blood donations are essential for surgeries, cancer treatment, chronic illnesses and traumatic injuries.

Vanderbilt, the only level-one trauma center in its region, has recalibrated the transfusions it uses to rescue patients — by using fewer red blood cells — to ensure that there is enough for all. “We still think that’s safe, and we know that saves lives,” Andrews said.

Other hospitals have altered treatment for some patients or canceled some patient surgeries, Red Cross officials said.

At Vanderbilt, “an elective surgery put off today is an emergency surgery tomorrow,” Andrews said. The medical staff has held two to three blood drives a month, up from one before the pandemic, to help replenish the center’s supplies, she said. But more is needed.

The nation’s blood supply also faced a critical shortage after March 2020 as the first wave of the coronavirus spread across the country. Blood drives were canceled when businesses closed, and many people — especially older Americans, who have traditionally been the most frequent donors — feared going into donation centers. At that time, the FDA eased some restrictions to help reverse the drastic drop in supply.

“We’ve overcome the fear of any sort of risk associated with a blood drive,” said Hrouda, who noted that the supply had largely bounced back until the delta variant began spreading over the summer. Blood bank directors are hoping that supply will once again catch up to demand.

“Every unit of blood is giving someone life,” Andrews said. “This holiday season, you can give the gift of life.” 
&nbsp;

The pandemic has caused many supply-chain bottlenecks in everyday life, but few are as critical as the United States’ ever-shrinking blood banks. For the American Red Cross, which supplies about 40% of the nation’s blood, and other nonprofit blood centers, the problem lies mostly at the top of the chain: the diminishing number of healthy donors.

The pandemic has caused many supply-chain bottlenecks in everyday life, but few are as critical as the United States’ ever-shrinking blood banks. For the American Red Cross, which supplies about 40% of the nation’s blood, and other nonprofit blood centers, the problem lies mostly at the top of the chain: the diminishing number of healthy donors. “This is the biggest challenge that I’ve seen in my 30 years in the business,” Chris Hrouda, president of biomedical services at the American Red Cross, said in an interview Thursday. Donations of blood typically decline at this time of year, when holiday parties, wintry weather, seasonal illnesses, travel, and school and college breaks lead to lower donor turnout. But Hrouda said this month’s national supply had dipped to levels that the Red Cross has not seen in 10 years. “We simply like to keep three days of inventory,” he said. “We’re struggling to keep one day.” Blood takes up to three days to be tested and prepared for patients. Remote work, blood drive cancellations, and the limits that colleges and businesses have placed on the number of people allowed in public spaces have all reduced donor turnout. “We just didn’t get as much access as we had hoped for this fall,” Hrouda said. Compounding the problem, the Red Cross, like many employers, is struggling to attract and retain employees amid the pandemic. The critical shortage leaves hospitals to more carefully allocate the precious resource. “We have not had to delay any cases yet, but we are very mindful" of what our blood supply is, said Dr. Jennifer Andrews, medical director of the Vanderbilt University Medical Center blood bank in Nashville, Tennessee. Blood donations are essential for surgeries, cancer treatment, chronic illnesses and traumatic injuries. Vanderbilt, the only level-one trauma center in its region, has recalibrated the transfusions it uses to rescue patients — by using fewer red blood cells — to ensure that there is enough for all. “We still think that’s safe, and we know that saves lives,” Andrews said. Other hospitals have altered treatment for some patients or canceled some patient surgeries, Red Cross officials said. At Vanderbilt, “an elective surgery put off today is an emergency surgery tomorrow,” Andrews said. The medical staff has held two to three blood drives a month, up from one before the pandemic, to help replenish the center’s supplies, she said. But more is needed. The nation’s blood supply also faced a critical shortage after March 2020 as the first wave of the coronavirus spread across the country. Blood drives were canceled when businesses closed, and many people — especially older Americans, who have traditionally been the most frequent donors — feared going into donation centers. At that time, the FDA eased some restrictions to help reverse the drastic drop in supply. “We’ve overcome the fear of any sort of risk associated with a blood drive,” said Hrouda, who noted that the supply had largely bounced back until the delta variant began spreading over the summer. Blood bank directors are hoping that supply will once again catch up to demand. “Every unit of blood is giving someone life,” Andrews said. “This holiday season, you can give the gift of life.”

US blood banks experiencing biggest shortage in a decade

The US Food and Drug Administration(FDA) on Sunday gave emergency authorization for doctors to use blood plasma from recovered coronavirus patients as a treatment against COVID-19.

<a href="https://www.wionews.com/world/trump-pitches-convalescent-plasma-as-an-effective-treatment-for-covid-19-321791">Also Read:&nbsp;Trump pitches convalescent plasma as an effective treatment for COVID-19</a>

"This product may be effective in treating COVID-19 and... the known and potential benefits of the product outweigh the known and potential risks of the product," FDA said in a statement.

Hailing the development, US President Donald Trump said: "Pleased to make a truly historic announcement, in our battle against China virus, that will save countless lives. FDA (Food &amp; Drug Administration) has issued an emergency use authorisation for a treatment known as convalescent plasma."

Trump said it was "only made possible because of Operation Warp Speed", while adding, "We are years ahead of approvals. If we went by the speed levels of the past administration, it would be 2-3 yrs behind where we're today."

The US president said that development on vaccines would be out soon. Trump had earlier linked the FDA to the “deep state” conspiracy theory, saying that the FDA was making "it very difficult for drug companies to get people to test the vaccines and therapeutics."

The US president had said that "they are hoping to delay the answer until after 3 November" when the US elections take place while asking the US agency to focus on "speed and saving lives".

The FDA had earlier announced convalescent plasma transfusions for critically ill coronavirus patients and for clinical trials as reports claimed 70,000 virus patients had received the treatment.

The United States is the worst-hit country with the virus accounting for over 176,700 deaths and more than 5.7 million infected cases.

The US Food and Drug Administration(FDA) on Sunday gave emergency authorization for doctors to use blood plasma from recovered coronavirus patients as a treatment against COVID-19.

The US Food and Drug Administration(FDA) on Sunday gave emergency authorization for doctors to use blood plasma from recovered coronavirus patients as a treatment against COVID-19. Also Read: Trump pitches convalescent plasma as an effective treatment for COVID-19 "This product may be effective in treating COVID-19 and... the known and potential benefits of the product outweigh the known and potential risks of the product," FDA said in a statement. Hailing the development, US President Donald Trump said: "Pleased to make a truly historic announcement, in our battle against China virus, that will save countless lives. FDA (Food & Drug Administration) has issued an emergency use authorisation for a treatment known as convalescent plasma." Trump said it was "only made possible because of Operation Warp Speed", while adding, "We are years ahead of approvals. If we went by the speed levels of the past administration, it would be 2-3 yrs behind where we're today." The US president said that development on vaccines would be out soon. Trump had earlier linked the FDA to the “deep state” conspiracy theory, saying that the FDA was making "it very difficult for drug companies to get people to test the vaccines and therapeutics." The US president had said that "they are hoping to delay the answer until after 3 November" when the US elections take place while asking the US agency to focus on "speed and saving lives". The FDA had earlier announced convalescent plasma transfusions for critically ill coronavirus patients and for clinical trials as reports claimed 70,000 virus patients had received the treatment. The United States is the worst-hit country with the virus accounting for over 176,700 deaths and more than 5.7 million infected cases.

US authorises blood plasma treatment against coronavirus; Trump hails move

The U.S. Food and Drug Administration is investigating whether the diabetes drug metformin had unsafe levels of a cancer-causing chemical and will recommend recalls as appropriate, the agency said on Thursday.

The move is part of the agency's broader push to investigate a range of drugs for the presence of the carcinogen, known as N-nitrosodimethylamine (NDMA), with popular heartburn medication Zantac being recalled this year for fear it contained NDMA.

The FDA later downplayed those fears, saying levels of contamination in the drug, also known as ranitidine, "are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats."

Health Canada said in a separate statement that it was not aware of any metformin products in Canada containing NDMA above acceptable limits, but was working closely with international regulatory partners on its assessment of the issue.

The Canadian health regulator has asked companies to test their metformin products and is collecting samples from them to conduct its own testing, it added.

Metformin is a first-line medication for the treatment of type 2 diabetes. It helps control high blood sugar and is marketed under a number of brand names, including Fortamet and Glucophage.

The FDA's investigation follows other countries' findings of low levels of NDMA in metformin drugs there, the agency said.

Based on its information, the FDA added, NDMA in those drugs ranged within naturally occurring levels in food and water.

"The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

The agency will "recommend recalls as appropriate if high levels of NDMA are found," she added in the statement.

Such action could put treatment out of reach for some sufferers, one expert said.

"If these reports are true, it could be a big blow to many millions of people on this drug," said Ranit Mishori, a professor of family medicine at Georgetown University.

"There are many other alternatives and other medication classes but many of them have side effects, are more expensive and some of the newest ones may not be covered by insurance."

The U.S. Food and Drug Administration is investigating whether the diabetes drug metformin had unsafe levels of a cancer-causing chemical and will recommend recalls as appropriate, the agency said on Thursday.

The U.S. Food and Drug Administration is investigating whether the diabetes drug metformin had unsafe levels of a cancer-causing chemical and will recommend recalls as appropriate, the agency said on Thursday. The move is part of the agency's broader push to investigate a range of drugs for the presence of the carcinogen, known as N-nitrosodimethylamine (NDMA), with popular heartburn medication Zantac being recalled this year for fear it contained NDMA. The FDA later downplayed those fears, saying levels of contamination in the drug, also known as ranitidine, "are similar to the levels you would expect to be exposed to if you ate common foods like grilled or smoked meats." Health Canada said in a separate statement that it was not aware of any metformin products in Canada containing NDMA above acceptable limits, but was working closely with international regulatory partners on its assessment of the issue. The Canadian health regulator has asked companies to test their metformin products and is collecting samples from them to conduct its own testing, it added. Metformin is a first-line medication for the treatment of type 2 diabetes. It helps control high blood sugar and is marketed under a number of brand names, including Fortamet and Glucophage. The FDA's investigation follows other countries' findings of low levels of NDMA in metformin drugs there, the agency said. Based on its information, the FDA added, NDMA in those drugs ranged within naturally occurring levels in food and water. "The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms," said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. The agency will "recommend recalls as appropriate if high levels of NDMA are found," she added in the statement. Such action could put treatment out of reach for some sufferers, one expert said. "If these reports are true, it could be a big blow to many millions of people on this drug," said Ranit Mishori, a professor of family medicine at Georgetown University. "There are many other alternatives and other medication classes but many of them have side effects, are more expensive and some of the newest ones may not be covered by insurance."

FDA probes diabetes drug metformin for carcinogen NDMA

The Food and Drug Administration raided three different places in Mumbai including Kandivali, Dahisar and busted places that were making ice cream without license.

According to reports, people were making ice cream illegally were using expired raw material, flavours and colours.

In Kandivali a company named 'Dipti Desert' was also raided from which, samples of cream and butterscotch has been taken to the lab.

Apart from this, 10 kg of cream cheese, which costs Rs 3750, 178 litres butterscotch ice cream, which is priced at Rs 48,950, has been seized.

According to the FDA department, there were violations regarding hygiene. The FDA also noticed Label contraventions.&nbsp;

Few pictures were also released which shows people working in extremely dirty conditions.

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<img alt="download (2).jpg" data-entity-type="" data-entity-uuid="" height="734" src="http://images.wionews.com/iniline-images/news/download%20(2).jpg" width="550" />

According to reports, people who were making ice cream illegally expired raw material, flavours and colours

The Food and Drug Administration raided three different places in Mumbai including Kandivali, Dahisar and busted places that were making ice cream without license. According to reports, people were making ice cream illegally were using expired raw material, flavours and colours. In Kandivali a company named 'Dipti Desert' was also raided from which, samples of cream and butterscotch has been taken to the lab. Apart from this, 10 kg of cream cheese, which costs Rs 3750, 178 litres butterscotch ice cream, which is priced at Rs 48,950, has been seized. According to the FDA department, there were violations regarding hygiene. The FDA also noticed Label contraventions. Few pictures were also released which shows people working in extremely dirty conditions.

Watch: Feeling the heat? Don't have ice-cream from this company

Global pressure on health spending is forcing the $1 trillion-a-year pharmaceutical industry to look for new ways to price its products: charging based on how much they improve patients&#39; health, rather than how many pills or vials are sold. 
 
In the United States, both parties are promising fresh action on drug prices whoever wins the White House. In Europe, economies are stalled, squeezing state health budgets. And in China and other Asian markets, governments are getting tougher with suppliers. 
 
Pricing drugs based on clinical outcomes is one way to ensure that limited funds bring the most benefits to patients now and pay for the most promising medical advances in future. Some experiments in pricing have already been made. 
 
But shifting the overall industry to a new model requires improvements in data collection and a change in thinking, say drug pricing experts. 
 
&quot;Eventually, we are going to get there,&quot; said Kurt Kessler, managing principal at ZS Associates in Zurich, which advises companies on sales and marketing strategies. &quot;But it is a long, tough slog because it&#39;s difficult to get the right data and agree on what the right outcomes are to measure.&quot; 
 
In the past, governments and insurers made room in their budgets for new drugs by switching to cheap generics as patents expired on older drugs. But today generics already account for nearly nine out of every 10 prescriptions in key markets like the United States, and fewer big drugs are going off patent. 
 
That leaves little headroom for pricey new medicines for cancer and other hard-to-treat diseases, even as they come to market in growing numbers. The US Food and Drug Administration has already approved 16 new drugs this year. 
 
Investors got a wake-up call on the issue last Friday when $10 billion was lopped off the market value of Novo Nordisk as the world&#39;s biggest diabetes firm warned of falling US prices. 
 
Pharmacy benefit managers administering US health plans are pushing back hard by excluding some drugs deemed too expensive - including Novo&rsquo;s - leading to a crunch in areas like diabetes, a disease that now accounts for 12 per cent of global healthcare spending. 
 
The Danish group has an unusually high exposure to the US market, but it is not alone in signaling tough times ahead. 
 
The chief executives of Novartis, Eli Lilly and GlaxoSmithKline have all warned recently that pricing will become increasingly challenging across the board. 
 
Accounting for 40 per cent of global drug sales, the fate of the US market is front and center in the minds of drug company executives, some of whom privately admit to preparing for a &quot;confrontational&quot; period in relations with politicians. 
 
Both Hillary Clinton and Donald Trump have suggested new measures to curb prices, including allowing imports from lower-cost countries, while individual US states, starting with Vermont, are working on transparency legislation that would require firms to disclose costs to justify drug prices. 
 
Novartis CEO Joe Jimenez believes drugmakers must develop value-for-money pricing models, like the performance-based deal the Swiss drugmaker recently struck with two US insurers for its new heart failure drug. 
 
Under that deal, payments for Novartis&#39; Entresto pill are to be calculated in future based on the proven reduction in the proportion of the insurers&#39; patients admitted to hospital for heart failure, not on the number of pills they consume. 
 
The aim is a flexible pricing system that rebates healthcare providers when a drug doesn&rsquo;t work as planned and charges more when it works well. 
 
Europe in vanguard 
 
Europe is in the vanguard of such moves. Britain agreed an early performance-based deal for a Johnson &amp; Johnson blood cancer drug back in 2007 and Italy also uses patient data to pay for cancer drugs based on actual patient responses. 
 
GSK CEO Andrew Witty sees this outcomes-based approach slowly becoming the norm in more disease areas and geographies. 
 
&quot;Whoever wins the election in the US, and also in Europe, we will see those conversations play out over the next few years,&quot; he told Reuters. &quot;I am not particularly expecting anything dramatic in 2017. I would say it is worth keeping an eye open for evolution of change, probably in &rsquo;18 and &rsquo;19.&quot; 
 
The pharmaceutical industry&#39;s European trade association is already discussing ways to shift to outcomes pricing, following price curbs in Germany that have caused some companies to pull products off the market, and effective rationing in Britain, where strict cost-effectiveness rules apply. 
 
Authorities in Asia&#39;s two biggest markets, China and Japan, are also intervening in new ways to cap runaway costs. 
 
Dani Saurymper, manager of the AXA Framlington Health fund, believes the issue is going to move up the agenda for investors, not least with the arrival of gene and cell therapies. These could cure diseases like haemophilia and certain cancers, but at a cost of hundreds of thousands or even $1 million a patient. 
 
&quot;Pay for performance is going to become much more relevant,&quot; he said. 
 
Still, the obstacles are formidable. Drug companies and healthcare providers will need to work together to develop systems that capture and prove a medicine&#39;s clinical value, ideally using computerized systems that are only just emerging. 
 
There are also potential legal pitfalls, given the need to establish clear-cut clinical outcomes for patients and determine how much of an effect should be attributed to the medicine or other healthcare inputs. 
 
&quot;Overall, it is the right direction but there are many practical difficulties,&quot; said Helen Roberts, a specialist in healthcare at law firm BonelliErede. &quot;There may well be legal challenges if there is disagreement as to whether an outcome has actually been achieved.&quot; 
 
(Reuters)

Global pressure on health spending is forcing the $1 trillion-a-year pharmaceutical industry to look for new ways to price its products

Global pressure on health spending is forcing the $1 trillion-a-year pharmaceutical industry to look for new ways to price its products: charging based on how much they improve patients' health, rather than how many pills or vials are sold. In the United States, both parties are promising fresh action on drug prices whoever wins the White House. In Europe, economies are stalled, squeezing state health budgets. And in China and other Asian markets, governments are getting tougher with suppliers. Pricing drugs based on clinical outcomes is one way to ensure that limited funds bring the most benefits to patients now and pay for the most promising medical advances in future. Some experiments in pricing have already been made. But shifting the overall industry to a new model requires improvements in data collection and a change in thinking, say drug pricing experts. "Eventually, we are going to get there," said Kurt Kessler, managing principal at ZS Associates in Zurich, which advises companies on sales and marketing strategies. "But it is a long, tough slog because it's difficult to get the right data and agree on what the right outcomes are to measure." In the past, governments and insurers made room in their budgets for new drugs by switching to cheap generics as patents expired on older drugs. But today generics already account for nearly nine out of every 10 prescriptions in key markets like the United States, and fewer big drugs are going off patent. That leaves little headroom for pricey new medicines for cancer and other hard-to-treat diseases, even as they come to market in growing numbers. The US Food and Drug Administration has already approved 16 new drugs this year. Investors got a wake-up call on the issue last Friday when $10 billion was lopped off the market value of Novo Nordisk as the world's biggest diabetes firm warned of falling US prices. Pharmacy benefit managers administering US health plans are pushing back hard by excluding some drugs deemed too expensive - including Novo’s - leading to a crunch in areas like diabetes, a disease that now accounts for 12 per cent of global healthcare spending. The Danish group has an unusually high exposure to the US market, but it is not alone in signaling tough times ahead. The chief executives of Novartis, Eli Lilly and GlaxoSmithKline have all warned recently that pricing will become increasingly challenging across the board. Accounting for 40 per cent of global drug sales, the fate of the US market is front and center in the minds of drug company executives, some of whom privately admit to preparing for a "confrontational" period in relations with politicians. Both Hillary Clinton and Donald Trump have suggested new measures to curb prices, including allowing imports from lower-cost countries, while individual US states, starting with Vermont, are working on transparency legislation that would require firms to disclose costs to justify drug prices. Novartis CEO Joe Jimenez believes drugmakers must develop value-for-money pricing models, like the performance-based deal the Swiss drugmaker recently struck with two US insurers for its new heart failure drug. Under that deal, payments for Novartis' Entresto pill are to be calculated in future based on the proven reduction in the proportion of the insurers' patients admitted to hospital for heart failure, not on the number of pills they consume. The aim is a flexible pricing system that rebates healthcare providers when a drug doesn’t work as planned and charges more when it works well. Europe in vanguard Europe is in the vanguard of such moves. Britain agreed an early performance-based deal for a Johnson & Johnson blood cancer drug back in 2007 and Italy also uses patient data to pay for cancer drugs based on actual patient responses. GSK CEO Andrew Witty sees this outcomes-based approach slowly becoming the norm in more disease areas and geographies. "Whoever wins the election in the US, and also in Europe, we will see those conversations play out over the next few years," he told Reuters. "I am not particularly expecting anything dramatic in 2017. I would say it is worth keeping an eye open for evolution of change, probably in ’18 and ’19." The pharmaceutical industry's European trade association is already discussing ways to shift to outcomes pricing, following price curbs in Germany that have caused some companies to pull products off the market, and effective rationing in Britain, where strict cost-effectiveness rules apply. Authorities in Asia's two biggest markets, China and Japan, are also intervening in new ways to cap runaway costs. Dani Saurymper, manager of the AXA Framlington Health fund, believes the issue is going to move up the agenda for investors, not least with the arrival of gene and cell therapies. These could cure diseases like haemophilia and certain cancers, but at a cost of hundreds of thousands or even $1 million a patient. "Pay for performance is going to become much more relevant," he said. Still, the obstacles are formidable. Drug companies and healthcare providers will need to work together to develop systems that capture and prove a medicine's clinical value, ideally using computerized systems that are only just emerging. There are also potential legal pitfalls, given the need to establish clear-cut clinical outcomes for patients and determine how much of an effect should be attributed to the medicine or other healthcare inputs. "Overall, it is the right direction but there are many practical difficulties," said Helen Roberts, a specialist in healthcare at law firm BonelliErede. "There may well be legal challenges if there is disagreement as to whether an outcome has actually been achieved." (Reuters)

Future of drug pricing: Paying for benefits not per pill