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Tag: COVID-19


FDA, Industry, Regulations, Vaccines

FDA Seeks to Simplify COVID-19 Vaccination Program

January 30, 2023

Via: Biopharm International

A more harmonized formula and schedule for administering COVID-19 vaccines gained strong support from FDA’s expert advisory panel last week, with agreement on the need to reduce confusion over which shot to take and when in order to increase vaccination […]


FDA, Industry, Regulations, Vaccines

FDA Experts Are Still Puzzled Over Who Should Get Which Covid Shots and When

January 27, 2023

Via: Kaiser Health News

At a meeting to simplify the nation’s covid vaccination policy, the FDA’s panel of experts could agree on only one thing: Information is woefully lacking about how often different groups of Americans need to be vaccinated. That data gap has […]


News

What Older Americans Need to Know About Taking Paxlovid

January 18, 2023

Via: Kaiser Health News

A new coronavirus variant is circulating, the most transmissible one yet. Hospitalizations of infected patients are rising. And older adults represent nearly 90% of U.S. deaths from covid-19 in recent months, the largest portion since the start of the pandemic. […]


Industry, Vaccines

Global Acceptance of COVID-19 Vaccines Is on the Rise

January 11, 2023

Via: Drugs.com

While COVID-19 vaccine acceptance rose around the world between 2021 and 2022, wide gaps remain, according to new research. Teams from the Barcelona Institute for Global Health in Spain (ISGlobal) and City University of New York (CUNY) also noted the […]


Industry, Vaccines

GSK and CureVac to advance mRNA COVID-19 and flu vaccine candidates

January 9, 2023

Via: PMLiVE

The tested vaccine candidates produced promising immunogenicity and reactogenicity profiles in ongoing phase 1 clinical programmes for COVID-19 and seasonal flu, assessing both modified and unmodified mRNA technology. “The positive results from this preliminary data analysis strongly validate the power […]


Clinical Trials, Research and Development

RQ Bio-discovered antibody enters clinic as part of AstraZeneca COVID-19 study

January 4, 2023

Via: PMLiVE

The start of the trial triggers a $5m milestone payment from AZ, which licensed AZD3152 from RQ Bio in May last year, and reinforces the financial position of the UK-based biotech to execute its four scientific programmes focused on viral […]


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 – […]