Food and Drug Administration

Science • Medicine
First long-acting injectable HIV drug combo approved by US FDA
Scanning electron micrograph of HIV-1 budding (in green) from cultured lymphocyte. This image has been colored to highlight important features; see PHIL 1197 for original black and white view of this image.
Scanning electron micrograph of HIV-1 budding (in green) from cultured lymphocyte. This image has been colored to highlight important features; see PHIL 1197 for original black and white view of this image. Credit: Photo Credit: C. GoldsmithContent Providers: CDC/ C. Goldsmith, P. Feorino, E. L. Palmer, W. R. McManus, Public domain, via Wikimedia Commons

The US Food and Drug Administration (FDA) has approved cabotegravir and rilpivirine injection – called Cabenuva – as a long-acting treatment for HIV-1 infections in adults. The new treatment is the first injectable treatment that has to be administered on a monthly basis, replacing daily pill medications to control the infection of the AIDS virus.

Health
USA approves Pfizer BioNtech Covid-19 vaccine
USA approves Pfizer BioNtech Covid-19 vaccine
Credit: Ashley Winkler for Pendect

The U.S. Food and Drug Administration (FDA) granted emergency approval Friday evening to the vaccine made by Mainz-based biotech company Biontech and its partner Pfizer.

The Washington Post reported that White House Chief of Staff Mark Meadows told Hahn on Friday to resign if the vaccine, made by Mainz-based Biontech and its U.S. partner Pfizer, is not approved before the end of the day (local time).

Regional News • Asia
Cannabis removed from Thailand's narcotics list
Cannabis removed from Thailand's narcotics list
Credit: unsplash.com / Next Green Wave

In order to allow wider use of marijuana for medical purposes, Thailand's Narcotics Control Board has voted to remove cannabis plants from the list of Category 5 narcotics.

However, growing marijuana is only allowed if a permit is granted by the FDA to ensure alignment with government agencies.

Health
Pfizer and BioNTech are submitting emergency use authorization request for their Covid-19 vaccine to the US FDA
Pfizer and BioNTech are submitting emergency use authorization request for their Covid-19 vaccine to the US FDA
Credit: Norbert Nagel, Mörfelden-Walldorf, Germany, via Wikimedia Commons (Creative Commons Attribution ShareAlike 3.0)

On Friday, Pfizer and BioNTech are submitting an emergency use authorization request for their Covid-19 vaccine to the US Food and Drug Administration. While it's unclear how long the process will take, the US government is expected to approve the vaccine until mid-December.

"The submission is based on a vaccine efficacy rate of 95% (p<0.0001) demonstrated in the companies’ Phase 3 clinical study in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from 7 days after the second dose," Pfizer said in a statement posted on its website.

Regional News • Americas • United States
Remdesivir approved as first Covid-19 treatment by US FDA
Remdesivir approved as first Covid-19 treatment by US FDA
Credit: unsplash.com / Dimitri Karastelev

The US Food and Drug Administration (FDA) has approved Remdesivir, a broad-spectrum antiviral medication, as the first Covid-19 treatment. According to a study by U.S. National Institutes of Health, Remdesivir can cut the time of recovery from 15 to 10 days.

Business • Health Care
F.D.A. issues emergency authorization for convalescent plasma as Covid-19 treatment
F.D.A. issues emergency authorization for convalescent plasma as Covid-19 treatment
Credit: Mehr News Agency / Wikimedia Commons (Creative Commons Attribution 4.0)

The US Food and Drug Administration has approved the use of convalescent plasma as Covid-19 treatment as the "known and potential benefits of the product outweigh the known and potential risks of the product." Even before the approval, around 70,000 people had been treated with convalescent plasma.

President Trump, after harshly criticising the speed of approval of treatments and vaccines, was pleased with the fast decision. "Today I am pleased to make a truly historic announcement in our battle against the China virus that will save countless lives. Today's action will dramatically increase access to this treatment," so the President.

Health
United States FDA authorize saliva-based Covid-19 test funded by NBA and NBPA
United States FDA authorize saliva-based Covid-19 test funded by NBA and NBPA
Credit: unsplash.com / NeONBRAND

A saliva-based Covid-19 test developed by the Yale University and funded by the National Basketball Association and the National Basketball Players Association has gotten emergency authorization by the United States Food and Drug Administration.

The new salvia test from Yale University only costs around $4, compared to $60 in the best cased for the competing salvia test that has been developed at Rutgers University lap. Both tests have been granted the same permission by the Food and Drug Administration.

Science • Medicine
Pfizer and US reach $1.95 billion deal for Covid-19 vaccine
Pfizer and US reach $1.95 billion deal for Covid-19 vaccine
Credit: Rhoda Baer (Photographer) / Public domain

The US government has agreed to pay $1.95 billion for 100 million Covid-19 vaccine doses to American pharmaceutical company Pfizer and German biotechnology company. The vaccine called BNT162 is currently still in development and early clinical trials. The agreement further states that the US could buy another 500 million doses, provided that the vaccine is both safe and effective as well as approved b the US Food and Drug Administration.

Regional News • Americas • United States
Approval of malaria drugs as Covid-19 treatment revoked in the US

The Unites States Food and Drug Administration (F.D.A.) has announced that they will revoke the emergency authorization for the usage of two malaria drugs as treatment for Covid-19. In the statement the F.D.A. states that the drugs are "unlikely to produce an antiviral effect".

Science • Medicine
Johnson & Johnson aiming to produce 1 billion doses of Covid-19 vaccines in 2021

Johnson & Johnson, multinational medical and pharmaceutical corporation, said in a statement on Sunday that they "aim to deliver 1 billion (Covid-19) vaccines next year". According to Paul Stoffels, chief scientific officer, the company is starting clinical trials in September and is planning to upscale their manufacturing to be able to start producing the vaccine late this year. Stoffel added “We will have some vaccine available this year, but it will depend on the authorities – the FDA and others – to decide whether it can be used earlier, before efficacy data are available".