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Tag: COVID-19


FDA, Industry, Regulations, Vaccines

FDA approves updated COVID-19 boosters for children aged from six months

December 9, 2022

Via: PMLiVE

The Pfizer/ BioNTech vaccine is now indicated for children aged six months to four years who have not yet received the third dose of the three-dose primary series with the monovalent Pfizer/BioNTech COVID-19 vaccine. Meanwhile, Moderna’s bivalent vaccine is now […]


Industry, Vaccines

EMA’s emergency task force backs bivalent COVID-19 vaccines for primary vaccination

December 7, 2022

Via: PMLiVE

In its decision, the ETF reviewed non-clinical studies and data on the immune response following natural infection with Omicron BA.4/BA.5 in unvaccinated people who had not been previously infected with SARS-CoV-2. The data suggested that primary vaccination with adapted bivalent […]


Clinical Trials, Research and Development

COVID in Pregnancy Can Vary — Get Vaccinated to Stay Safe

November 28, 2022

Via: Drugs.com

When pregnant women contract COVID-19, one in 10 will have moderate, severe or even critical symptoms, a new study finds. So it’s important they get their COVID vaccines, experts say. “Given that patients in all trimesters of pregnancy are susceptible […]


Clinical Trials, Industry, Research and Development, Vaccines

Sanofi/GSK’s next-generation COVID-19 booster granted EC approval

November 14, 2022

Via: PMLiVE

Shipments of the Beta-targeting booster are ready to be distributed to European countries as per advance purchase agreements, the companies said in a statement, in time for autumn/winter COVID-19 vaccination campaigns. “Today’s approval validates our research in developing a novel […]


Industry, Vaccines

Keeping the pandemic at bay with needle-free vaccine delivery

September 20, 2022

Via: Pharmaphorum

Vaccines have transitioned from being a largely unloved area of the industry, with multiple big pharma companies divesting their vaccine divisions, to the biggest revenue drivers seen in recent years. This all comes down to the impact of the pandemic. […]


News

WHO Advises against Antibody Drugs for COVID-19 Patients

September 19, 2022

Via: GEN

The World Health Organization (WHO) Guideline Development Group recommended that patients with COVID-19 not receive the antibody drugs sotrovimab and casirivimab-imdevimab. The Group’s recommendation replaces previous conditional recommendations “Rapid Recommendations: A living WHO guideline on drugs for Covid-19,” published in […]


Clinical Trials, Research and Development

COVID-19 has changed clinical trials for the better, says Medidata

September 9, 2022

Via: Pharmaphorum

The pandemic forced clinical trial sponsors to change their processes, with a more technology-driven approach and, according to a new study by Medidata, the sector is now “stronger than ever” as a result. The study, based on interviews conducted earlier […]


News

Vitamin D Supplements Won’t Shield You From COVID-19, Studies Find

September 8, 2022

Via: Drugs.com

While vitamin D got some attention early in the pandemic, it does not reduce the risk of either COVID-19 or other respiratory infections, two new clinical trials found. Both studies, one done in the United Kingdom and the other in […]


Industry, Vaccines

First Needle-Free COVID Vaccines Get OK in India, China

September 7, 2022

Via: Drugs.com

While researchers explore the possibilities of COVID-19 vaccines that don’t require an injection, public health officials in India and China have already each approved new needle-free versions for their citizens. In India, regulators on Tuesday approved a nasal vaccine developed […]


Industry, Vaccines

COVID Vaccines Likely to Become Annual Shots: White House

September 7, 2022

Via: Drugs.com

COVID-19 vaccines will likely go the way of flu shots in the future, with updated doses given annually, U.S. health officials said Tuesday. “In the absence of a dramatically different variant, we likely are moving towards a path with a […]


Industry, Vaccines

Pfizer bivalent COVID-19 vaccine starts rollout

September 6, 2022

Via: Pharmaphorum

The NHS is moving to the next phase of its SARS-CoV-2 vaccination programme, following health secretary Steve Barclay’s acceptance of advice from the Joint Committee on Vaccination and Immunisation (JCVI) to go ahead with rollout of Pfizer’s bivalent 30mg booster […]


News

Dr. B: Expanding the business model from COVID vaccines to antiviral medications

September 1, 2022

Via: Pharmaphorum

Cyrus Massoumi, founder of Dr. B, tells us about his online platform that makes physician assessment readily available to patients and provides access to COVID-19 therapeutics that may otherwise be difficult to obtain. COVID-19 antiviral medications Paxlovid (nirmatrelvir/ritonavir) and Lagevrio […]


FDA, Regulations

FDA Authorizes Pfizer, BioNTech Omicron Adapted COVID-19 Vax Booster

August 31, 2022

Via: Contract Pharma

Pfizer Inc. and BioNTech SE was granted Emergency Use Authorization (EUA) by the U.S. FDA for a 30-µg booster dose of the Pfizer-BioNTech COVID-19 vaccine, bivalent (Original [15 µg] and Omicron BA.4/BA.5 [15 µg]) for individuals ages 12 years and […]


FDA, Regulations

FDA clears bivalent Omicron shots from Pfizer, Moderna

August 31, 2022

Via: Pharmaphorum

The US regulator has cleared a 30 µg booster dose of a new version of Pfizer’s Comirnaty shot – 15 µg encoding the spike protein of the original wild-type SARS-CoV-2 strain and 15-µg of mRNA coding for Omicron BA.4/BA.5 – […]


Industry, Vaccines

Moderna sues Pfizer/BioNTech over COVID-19 vaccine tech

August 26, 2022

Via: Pharmaphorum

Moderna has filed complaints in the US and Germany claiming that the mRNA technology used to make Pfizer and BioNTech’s Comirnaty vaccine infringes multiple patents that cover its own Spikevax shot. Among the claims is that Comirnaty was developed using […]


Industry, Vaccines

Biden Administration May Stop Buying COVID Vaccines, Treatments by Fall

August 17, 2022

Via: Drugs.com

The Biden Administration plans to stop buying COVID tests, vaccines and treatments as early as the fall, White House COVID-19 Response Coordinator Dr. Ashish Jha said Tuesday. Under that plan, those products would be provided through the regular health care […]


Industry, Vaccines

JCVI publishes advice on COVID-19 vaccines ahead of autumn booster campaign

August 17, 2022

Via: PMLiVE

For adults aged 18 years and above, the JCVI’s advised vaccines include Moderna’s mRNA (Spikevax) bivalent Omicron BA.1/original wild-type vaccine, as well as its mRNA (Spikevax) original wild-type vaccine. The Pfizer/BioNTech mRNA (Comirnaty) original wild-type vaccine is also advised, and […]


Industry, Vaccines

New needle-free nasal vaccine shows promise for COVID-19

July 28, 2022

Via: World Pharma News

New research shows that a needle-free mucosal bacteriophage (phage) T4-based COVID-19 vaccine is effective against SARS-CoV-2 infection. The findings were published in mBio, an open access journal of the American Society for Microbiology. In recent years, the Food and Drug […]


Industry, Pharma

Everything You Need to Know About Paxlovid — Especially, Should You Take It?

July 28, 2022

Via: Kaiser Health News

When President Joe Biden tested positive for covid-19 on July 21, his physician recommended he take the antiviral drug Paxlovid. The drug significantly reduces the likelihood of hospitalization or death for someone at high risk of developing severe covid. Biden […]


Editorial

New Drugs Could Help Patients with Serious Brain Disorders

July 22, 2022

Via: Natalie Dunn

While the COVID-19 pandemic wreaked havoc and forced scientists and policymakers to create or search for vaccines and treatments, common disorders continued to affect millions of human lives. The pandemic made it harder for people suffering from chronic conditions to […]