SEARCH

Current Edition

COVID-19

FDA places stricter limits on J&J’s COVID-19 vaccine after review of rare side effect

Dive Brief: The Food and Drug Administration has determined that the risk of a rare, but serious, clotting syndrome tied to Johnson & Johnson’s COVID-19 …

Continue Reading →
Amgen

FDA sets back Novartis’ best chance at a COVID-19 drug

Dive Brief: Novartis is reevaluating its commitment to an experimental COVID-19 treatment originally developed by fellow Swiss drug company Molecular Partners after the Food and …

Continue Reading →
COVID-19

Drug price hikes moderate as rebates rise, report finds

Dive Brief: List prices of branded drugs in the U.S. rose by an average of nearly 5% last year, according to a report released Thursday …

Continue Reading →
COVID-19

FDA advisers grapple with how to update COVID-19 vaccines

A group of advisers to the Food and Drug Administration agreed Wednesday that COVID-19 vaccines will likely need to be updated to keep pace with …

Continue Reading →
children

Moderna, with new data, to seek clearance for COVID-19 vaccine in young children

Moderna on Wednesday said its COVID-19 vaccine spurred strong immune responses in a large study testing the shot in children as young as 6 months …

Continue Reading →
adults

Moderna, citing need for ‘flexibility,’ seeks broad clearance of fourth COVID shot

Dive Brief: Moderna has asked the Food and Drug Administration to clear a fourth dose of its COVID-19 vaccine for adults 18 and over, a …

Continue Reading →
Atlas

Amid biotech downturn, Atlas raises $450M to build new drug startups

Dive Brief: Atlas Venture, a prolific creator of biotech startups, has raised $450 million to form and invest in new drug companies, announcing Thursday the …

Continue Reading →
coronavirus

Sanofi and GSK, after delays, to seek clearance for COVID-19 vaccine

Sanofi and GlaxoSmithKline plan to seek authorization for their experimental coronavirus vaccine in the U.S. and abroad after their shot prevented COVID-19 in a large …

Continue Reading →
COVID-19

Pfizer forecasts $100B in sales, fueled by COVID-19 vaccine, pill

Dive Brief: Pfizer on Tuesday forecast that its revenue this year will grow to total between $98 billion and $102 billion, which, measured at the …

Continue Reading →
Comirnaty

Pfizer lures research chief from Roche, prompting high-level reshuffle

Dive Brief: Pfizer is hiring William Pao, currently Roche’s head of pharmaceutical research and early development, to serve as its chief development officer and executive …

Continue Reading →
BioNTech

With new trial, Pfizer and BioNTech will test whether an omicron vaccine is needed

Dive Brief: Pfizer and BioNTech have begun enrolling patients in a study testing a new version of their COVID-19 vaccine specifically tailored to the omicron …

Continue Reading →
booster

Moderna follows Pfizer in beginning trial of omicron vaccine

Dive Brief: Moderna on Wednesday said it has begun a trial testing a new version of its COVID-19 vaccine that’s tailored to the omicron variant, …

Continue Reading →
Adagio

Adagio, after bold promises, says antibody drug won’t work well against omicron

The findings are a huge disappointment for Adagio, which billed ADG20 as a weapon that could neutralize a wide range of variants and help with …

Continue Reading →
booster

Sanofi, GSK say COVID vaccine works as booster, but delay key study results

Sanofi and GSK expected to have definitive results for their long-delayed coronavirus vaccine by now, having redesigned their shot after an initial formulation disappointed late …

Continue Reading →
COVID-19

Vaccine from Medicago, GSK protective against COVID-19 in large study

Most of the vaccines approved to date use either messenger RNA or DNA to coax the body’s cells to produce the spike protein, or are …

Continue Reading →
antibody treatment

AstraZeneca antibody cleared by FDA for preventive use against COVID-19

AstraZeneca’s drug, called Evusheld, is the fifth COVID-19 antibody treatment authorized by the FDA, and the fourth now available after Lilly pulled one of its …

Continue Reading →
Antibody

Regeneron warns its antibody drug may be less potent versus omicron

Regeneron’s drug is the top-selling COVID-19 treatment in the U.S., one of three antibody drugs currently authorized by the Food and Drug Administration for people …

Continue Reading →
boosters

FDA, aiming to curb another COVID-19 surge, clears Pfizer, Moderna boosters for all adults

The Food and Drug Administration on Friday authorized COVID-19 booster shots for all vaccinated Americans over 18, a move that’s meant to stem a rise …

Continue Reading →
adults

Pfizer again asks FDA to authorize COVID-19 boosters for all adults

Agency advisers had opposed a broad booster dose clearance in September, leading the FDA to limit use to older adults and those at high risk …

Continue Reading →
5-11 year olds

CDC panel unanimously backs use of Pfizer’s COVID-19 vaccine in young children

The CDC meeting Tuesday emphasized COVID-19’s cost on young children, who, while less at risk than older adults, are still susceptible to disease, hospitalization and …

Continue Reading →