The US Food & Drugs Administration (FDA) advisors will meet on the December 10 to discuss whether to authorise the Pfizer COVID-19 vaccine for emergency use. The advisory committee will discuss the safety & effectiveness of the vaccine candidate.

FDA panel to discuss Pfizer vaccine on December 10

The US Food and Drug Administration on Monday granted emergency approval to a synthetic antibody treatment against Covid-19 developed by Eli Lilly, after the drug was shown to reduce the risk of hospitalization and emergency room visits.

Bamlanivimab at a dose of 700 milligrams was authorized for the treatment of mild-to-moderate Covid-19 in adults and children aged 12 years and older who are at high risk for progressing to the severe form of the disease.

It is the first drug to be approved that was designed specifically against the new coronavirus.

"As illustrated by today's action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments," said the agency's chief Stephen Hahn.

The approval was based on a mid-stage clinical trial for outpatients with mild to moderate Covid-19, where the intravenous treatment was shown to reduce viral loads and rates of symptoms and hospitalization.&nbsp;

The FDA said in its statement that the most important evidence that bamlanivimab may be effective came from data that showed that among patients at high risk of severe disease, hospitalizations and emergency room visits occurred in 3 percent of bamlanivimab-treated patients compared to 10 percent who were on the placebo.

The frequency and types of side effects were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity.&nbsp;

The most common were diarrhea, dizziness, headache, itchiness and vomiting.

The trial is ongoing and aims to enroll more than 800 patients across various dosage groups.

An important caveat is that bamlanivimab has not been authorized for patients who are hospitalized -- since no benefit has been shown for patients who are already in this late stage of the disease, when the body's immune defenses go into overdrive and damage organs.

The FDA wrote that administering the drug too late could be associated with worse outcomes, and a trial exploring bamlanivimab in hospitalized patients was suspended last month over a safety incident.

Bamlanivimab is what's known as a monoclonal antibody, a relatively new class of drugs that are best known for treating certain types of cancer and autoimmune disease.

Human immune systems produce antibodies, which are infection-fighting proteins, and vaccines teach our bodies to be prepared to make the right ones for particular pathogens.

Bamlanivimab was based on an effective antibody Lilly found in a recovered patient.

The host immune cells that produce the antibodies can be cultured in a lab to produce the desired proteins en masse.

It works by binding to a surface protein of the coronavirus to stop it from invading human cells.

The US Food and Drug Administration on Monday granted emergency approval to a synthetic antibody treatment against Covid-19 developed by Eli Lilly, after the drug was shown to reduce the risk of hospitalization and emergency room visits.

The US Food and Drug Administration on Monday granted emergency approval to a synthetic antibody treatment against Covid-19 developed by Eli Lilly, after the drug was shown to reduce the risk of hospitalization and emergency room visits. Bamlanivimab at a dose of 700 milligrams was authorized for the treatment of mild-to-moderate Covid-19 in adults and children aged 12 years and older who are at high risk for progressing to the severe form of the disease. It is the first drug to be approved that was designed specifically against the new coronavirus. "As illustrated by today's action, the FDA remains committed to expediting the development and availability of potential COVID-19 treatments," said the agency's chief Stephen Hahn. The approval was based on a mid-stage clinical trial for outpatients with mild to moderate Covid-19, where the intravenous treatment was shown to reduce viral loads and rates of symptoms and hospitalization. The FDA said in its statement that the most important evidence that bamlanivimab may be effective came from data that showed that among patients at high risk of severe disease, hospitalizations and emergency room visits occurred in 3 percent of bamlanivimab-treated patients compared to 10 percent who were on the placebo. The frequency and types of side effects were similar between bamlanivimab and placebo, with the majority being mild to moderate in severity. The most common were diarrhea, dizziness, headache, itchiness and vomiting. The trial is ongoing and aims to enroll more than 800 patients across various dosage groups. An important caveat is that bamlanivimab has not been authorized for patients who are hospitalized -- since no benefit has been shown for patients who are already in this late stage of the disease, when the body's immune defenses go into overdrive and damage organs. The FDA wrote that administering the drug too late could be associated with worse outcomes, and a trial exploring bamlanivimab in hospitalized patients was suspended last month over a safety incident. Bamlanivimab is what's known as a monoclonal antibody, a relatively new class of drugs that are best known for treating certain types of cancer and autoimmune disease. Human immune systems produce antibodies, which are infection-fighting proteins, and vaccines teach our bodies to be prepared to make the right ones for particular pathogens. Bamlanivimab was based on an effective antibody Lilly found in a recovered patient. The host immune cells that produce the antibodies can be cultured in a lab to produce the desired proteins en masse. It works by binding to a surface protein of the coronavirus to stop it from invading human cells.

US grants emergency approval to 'Bamlanivimab' Covid-19 antibodies

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Trump said it was 'only made possible because of Operation Warp Speed', while adding, 'We are years ahead of approvals.'

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Tropical Storm Laura brought in heavy rain and is predicted to hit the US coastal region on Wednesday.

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Tarrant has pleaded guilty to 51 charges of murder, 40 of attempted murder and one of terrorism.

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US FDA authorises blood plasma treatment against coronavirus; Trump hails move Trump said it was 'only made possible because of Operation Warp Speed', while adding, 'We are years ahead of approvals.

US FDA authorises blood plasma treatment against coronavirus; Trump hails move Trump said it was 'only made possible because of Operation Warp Speed', while adding, 'We are years ahead of approvals.' 8 dead as Storm Laura hits Haiti; Storm Marco set to hit Louisiana Tropical Storm Laura brought in heavy rain and is predicted to hit the US coastal region on Wednesday. Attacker wanted to burn down the two Christchurch mosques, court told Tarrant has pleaded guilty to 51 charges of murder, 40 of attempted murder and one of terrorism. Bayern Munich beat Paris Saint-Germain in Champions League final Bayern won the engaging final with a 1-0 margin after former PSG 24-year-old Kingsley Coman headed Joshua Kimmich's cross in the second half. Watch: Lithuania citizens form human chain to support Belarus anti-govt protests

Morning news brief: US FDA authorises blood plasma for COVID-19; Bayern Munich beat Paris Saint-Germain to win Champions League

Food and Drug Administration (FDA) approved the first at-home COVID-19 test kit. People would now be able to get tested for COVID-19 at home. The US President Donald Trump on Friday (April 24) promoted the roll out of the first in-home test for the coronavirus that the FDA had granted emergency clearance to.

FDA grants emergency clearance to at-home COVID-19 tests

The Trump administration on Thursday said it would ban<a href="https://www.wionews.com/world/us-state-upholds-e-cigarette-ban-amid-vaping-deaths-253923"> flavoured e-cigarettes</a> to prevent the youth from taking to it&nbsp; but did not order a full ban.

Cartridge-based e-cigarettes in flavors other than tobacco or menthol would be illegal unless specifically authorized by the government, the US Food and Drug Administration (FDA) said.

The agency said the directive will come into effect in February.&nbsp;According to the new guidelines, cartridges with fruit, mint and candy flavors have been banned.

"We have to protect our families. At the same time, it's a big industry, we want to protect the industry," Trump said later.

A report earlier by CDC had said that have been 2,051 confirmed and probable US lung injury cases and 39 deaths associated with use of e-cigarettes.

The Trump administration had said last&nbsp;year that Food and Drug Administration(FDA) was working on a "guidance document" that would lead to a ban of all e-cigarette flavours, aside from tobacco flavouring. 
&nbsp; 
Trump had said earlier that he wanted the minimum age for vaping to be increased to 21, but hasn't announced anything in this regard.

The Trump administration on Thursday said it would ban flavoured e-cigarettes to prevent the youth from taking to it but did not order a full ban. Cartridge-based e-cigarettes in flavors other than tobacco or menthol would be illegal unless specifically authorized by the government, the US Food and Drug Administration (FDA) said.

The Trump administration on Thursday said it would ban flavoured e-cigarettes to prevent the youth from taking to it but did not order a full ban. Cartridge-based e-cigarettes in flavors other than tobacco or menthol would be illegal unless specifically authorized by the government, the US Food and Drug Administration (FDA) said. The agency said the directive will come into effect in February. According to the new guidelines, cartridges with fruit, mint and candy flavors have been banned. "We have to protect our families. At the same time, it's a big industry, we want to protect the industry," Trump said later. A report earlier by CDC had said that have been 2,051 confirmed and probable US lung injury cases and 39 deaths associated with use of e-cigarettes. The Trump administration had said last year that Food and Drug Administration(FDA) was working on a "guidance document" that would lead to a ban of all e-cigarette flavours, aside from tobacco flavouring. Trump had said earlier that he wanted the minimum age for vaping to be increased to 21, but hasn't announced anything in this regard.

Trump administration announces partial ban on flavoured e-cigarettes

US pharmaceutical and cosmetics group Johnson &amp; Johnson saw its shares plunge Friday after a media report alleged the group had deliberately concealed for decades that its baby powder sometimes contained asbestos.

A lengthy investigation by the Reuters news agency, which reviewed thousands of company documents, showed the company marketed talc-based products that, at least between 1971 and the beginning in the 2000s, sometimes contained asbestos.

The company's executives, researchers, doctors and lawyers were aware but deliberately chose not to disclose this information and not to refer it to the authorities, according to the report.

Johnson &amp; Johnson strenuously rejected the claims made in the article, calling it "one-sided, false and inflammatory."

"Simply put, the Reuters story is an absurd conspiracy theory," the company said in a statement. "Johnson &amp; Johnson's baby powder is safe and asbestos-free."

J&amp;J stock closed down more than 10 per cent at $133 on the New York Stock Exchange, its worst one-day fall in 16 years.

The controversy has long dogged the company, which has been facing a wave of several thousand court cases claiming the baby powder is causing cancer.&nbsp;

In July, Johnson &amp; Johnson was ordered to pay $4.7 billion in damages to a group of 22 women claiming to have developed ovarian cancer following the use of the powder.

The company said Friday there were rigorous tests showing the talc did not contain the cancer-causing mineral.

In addition, "J&amp;J has cooperated fully and openly with the US FDA and other global regulators, providing them with all the information they requested over decades."

According to Reuters, the company also tried, unsuccessfully, to block regulations that lower the maximum level of asbestos allowed in talc-based cosmetics.

US pharmaceutical and cosmetics group Johnson & Johnson saw its shares plunge Friday after a media report alleged the group had deliberately concealed for decades that its baby powder sometimes contained asbestos.

US pharmaceutical and cosmetics group Johnson & Johnson saw its shares plunge Friday after a media report alleged the group had deliberately concealed for decades that its baby powder sometimes contained asbestos. A lengthy investigation by the Reuters news agency, which reviewed thousands of company documents, showed the company marketed talc-based products that, at least between 1971 and the beginning in the 2000s, sometimes contained asbestos. The company's executives, researchers, doctors and lawyers were aware but deliberately chose not to disclose this information and not to refer it to the authorities, according to the report. Johnson & Johnson strenuously rejected the claims made in the article, calling it "one-sided, false and inflammatory." "Simply put, the Reuters story is an absurd conspiracy theory," the company said in a statement. "Johnson & Johnson's baby powder is safe and asbestos-free." J&J stock closed down more than 10 per cent at $133 on the New York Stock Exchange, its worst one-day fall in 16 years. The controversy has long dogged the company, which has been facing a wave of several thousand court cases claiming the baby powder is causing cancer. In July, Johnson & Johnson was ordered to pay $4.7 billion in damages to a group of 22 women claiming to have developed ovarian cancer following the use of the powder. The company said Friday there were rigorous tests showing the talc did not contain the cancer-causing mineral. In addition, "J&J has cooperated fully and openly with the US FDA and other global regulators, providing them with all the information they requested over decades." According to Reuters, the company also tried, unsuccessfully, to block regulations that lower the maximum level of asbestos allowed in talc-based cosmetics.

Johnson & Johnson shares plunge after report on asbestos in baby powder

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