By Leroy Leo
Jan 26 (Reuters) – Novavax Inc said on Thursday it would require six months to produce a COVID-19 vaccine designed to match whichever coronavirus variants are circulating for an annual immunization program each fall season in the United States.
The company suggested that the U.S. Food and Drug Administration select the prevalent variant of coronavirus in the first quarter each year, similar to the model employed to choose the composition for annual flu shots.
The FDA in documents released on Monday proposed June for deciding on an annual COVID shot's make-up.
Novavax's protein-based vaccine requires manufacturing changes that take longer to implement than the messenger RNA vaccines produced by Pfizer Inc/BioNTech SE and Moderna Inc. It took those companies about three months to produce the currently available boosters updated to target newer Omicron subvariants.
"We recognize the tension between selecting a strain as late as possible to increase the likelihood of recommending a matching strain versus providing adequate time to ensure vaccine availability," Novavax Chief Medical Officer Filip Dubovsky said during a presentation for the FDA's vaccine advisory panel.
The FDA is seeking recommendations from its panel of external experts on adopting an annual COVID shot for the United States and the process for choosing the vaccine's targets each year. (Reporting by Leroy Leo in Bengaluru Editing by Bill Berkrot)
An FDA advisory committee voted to swap in the bivalent shots now used as boosters for the vaccines given for primary series.
J&J (JNJ) reports mixed fourth-quarter results. Merck (MRK) discontinues an advanced prostate cancer study on blockbuster drug Keytruda for futility.
A Food and Drug Administration advisory panel voted unanimously on Thursday for Americans to get a once-a-year booster against COVID with the strain to be decided mid-year for a fall campaign, the Associated Press reported. The panel agreed that people should get the same vaccine formula whether they're receiving their initial vaccinations or a booster. Today, Americans get one formula based on the original coronavirus strain that emerged in 2020 for their first two or three doses – and their la
NFT companies that failed to acknowledge an obscure 1997 law may be obligated to refund European customers in full for past purchases.
An FDA advisory committee unanimously votes in favor of using the same COVID-19 vaccine strain composition for primary series and booster doses.
Brussels is discussing with Pfizer and BioNTech the possibility of reducing the up to 500 million COVID-19 vaccine doses the EU has committed to buy this year in return for a higher price, a source with knowledge of the talks said. The talks come amid of global glut of COVID-19 shots, and relate to the biggest contract for vaccines of all those signed by the EU while the pandemic raged. A European Commission spokesperson asked for comment on the talks called on vaccine makers to work with member states and the Commission "to ensure that the agreements reflect the changing situation".
Lehigh Valley Health Network has opted to close its five vaccine clinics, though the medical provider will still offer shots through LVHN doctors.
Novavax plans to update its Covid vaccine for new variants, and NVAX stock outperformed its vaccine stock rivals.
Biogen (BIIB) and Eisai jointly announce that EMA accepts lecanemab's marketing authorization application (MAA) for the treatment of patients with early-stage Alzheimer's disease, for review.
(Bloomberg) — A $50 billion selloff in Adani Group’s empire following US short seller Hindenburg Research’s scathing allegations has dragged the NSE Nifty 50 Index to its lowest since Oct. 21 with the stocks becoming the top losers in the Indian gauge.Most Read from BloombergAdani Rout Crosses $51 Billion as Stocks Plunge by Daily LimitsPutin Plans New Ukraine Push Despite Losses as He Prepares for Years of WarWe Asked ChatGPT to Make a Market-Beating ETF. Here’s What HappenedHindenburg vs Adan
If you want solid healthcare stocks that will be worth buying and holding for the next 10 years, you need to set the bar pretty high. But thanks to its portfolio and late-stage pipeline therapies, its next few years should feature strong growth.
Cutting hours is meant to help ease workload for employees and better serve customers, say pharmacy chains.
Investors are reading between the lines to see if the company is fixing its problems regarding its lead therapy.
Every drug comes with potential side effects. People taking Ozempic are discovering the issues that come with the weight loss medication that’s so trendy there's a shortage.View Entire Post ›
AstraZeneca's (AZN) Evusheld is no longer authorized for use in the United States after laboratory data showed that it does not neutralize Omicron subvariants.
MARKET PULSE Shares of Regeneron Pharmaceuticals Inc. (REGN) gained about 2.5% in premarket trading on Friday after the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval of Dupixent, the atopic dermatitis therapy developed with Sanofi (FR:SAN) (SNY) for children as young as six months old.
People across social media have documented changes to their faces after using Ozempic.
The company is testing Carvykti in multiple myeloma patients, with a history of relapse, who have stopped responding to existing treatment and have received one to three prior therapies. Carvykti, developed by J&J and its China-focused partner Legend Biotech Corp, was approved by the U.S. health regulator last year based on an early-to mid-stage study to treat relapsed or refractory multiple myeloma patients who had received four or more prior lines of therapy. U.S.-listed shares of Legend Biotech were up 2% in early trading.
Because new medicines come with patent protection for lengthy periods of time, the pharmaceutical industry is unsurprisingly a very lucrative one. Few companies do these two things better than Merck (NYSE: MRK). Earlier this month the pharmaceutical giant closed its $1.35 billion, all-cash deal with the oncology company Imago BioSciences.
The wholesale cost of the treatment, Jaypirca, will be $21,000 per 30 days for the 200 mg dose, the U.S. drugmaker told Reuters. The Food and Drug Administration's accelerated approval for Jaypirca marks the first of the five treatments the U.S. drugmaker hopes to launch this year, including one for obesity. The drug, which is expected to be available in the United States in the coming weeks, aims to treat adults with mantle cell lymphoma after at least two lines of therapy.