FDA staff signaled support for Celltrion's biosimilar of Johnson & Johnson's Remicade in documents released ahead of a key panel vote, a positive development for the South Korean company as it works with Pfizer to tap the U.S. market.
Cambridge, MA-based Affinivax launched in November 2014 with a $4 million Gates Foundation investment and plans to develop a pneumococcal vaccine that it believes could go beyond Prevnar, the best-selling vaccine in the world. Now, the biotech is announcing $2.5 million in follow-on funding from the Gates Foundation, which it will use to advance its lead candidate, CEO Steve Brugger told FierceVaccines.
While the early entrants to the race for a Zika vaccine have been on the smaller side--think Hawaii Biotech, NewLink Genetics and Inovio Pharmaceuticals--the big guns are now joining in. Just one day after Sanofi announced a firm plan to develop a vaccine for the mosquito-borne disease, a parade of Big Pharmas has joined GlaxoSmithKline in "evaluating their technologies" for the potential of developing a Zika vaccine.
After a monster year, the "low-hanging fruit" is gone for Pfizer's Prevnar 13 as the company looks to penetrate the adult market in the U.S. But fear not, investors, execs said Tuesday--there's plenty left in Europe.
Pfizer came through a hectic fourth quarter with a major deal pending and at work on integrating an earlier one while at the same time trying to identify niches for both in emerging markets and particularly China.
Norway became the first overseas country to approve the Enbrel biosimilar made by Samsung Bioepis for sale, coming two weeks after the drug, Benepali, was approved by the European Commission.
Riding Prevnar 13 uptake, Pfizer's vaccines unit capped off a big growth year on Tuesday, reporting Q4 sales increases of 45% and full-year 2015 growth of 44%.
Pfizer posted fourth-quarter earnings that satisfied investors and analysts. But its guidance for 2016? Not so much.
Pfizer has quietly shuttered a Phase II Alzheimer's drug study, noting the termination in a pipeline update released today with its annual numbers for 2015. And shares of Axovant tumbled 16% on the news as it faces fresh questions about the implications of the failure on a similar drug it has pushed into a Phase III trial.
Allergan's $160 billion inversion merger with Pfizer and its attendant whacking of U.S. taxes has raised some hackles in Washington. Now, Allergan seems to be offering a bit of sugar to make the tax-avoiding medicine go down by talking about doubling employment at its flagship plant in Texas.