In 2015, the FDA by its own account approved 45 new drugs, the largest one-year tally since 1996, which wrapped up with a record 53 regulatory OKs. Now, here's the full list of new drugs approved by the FDA in 2015, in chronological order.
With one biosim already on the U.S. market, and more poised for a 2016 liftoff, next year will give drugmakers and payers a taste of the biosim contest to come.
The companies say that these two Phase III studies bring the late-stage program up to 6 studies, meeting their goal for 2015.
Bayer may have a big-time move up its sleeve, Reuters ' sources say--and it could include animal health leader Zoetis or Pfizer's consumer offerings.
Remsima, a biosimilar of Johnson & Johnson's Remicade from Pfizer's Hospira and partner Celltrion, is tearing it up in Europe. But don't expect things to play out the same way in the U.S., a Bernstein analyst says.
The tax benefits of buying Allergan are Pfizer's No. 1 reason for doing the $160 billion deal. In fact, some analysts see the $2 billion in potential tax savings as the merger's only substantial advantage.
Cheaper Chinese versions of erectile dysfunction (ED) treatments Viagra and Cialis are threatening to eat into the market share of the Western-made drugs as some of the 127 million Chinese men suffering from ED turn to domestic alternatives.
Pfizer's Xalkori is already used to treat patients with metastatic non-small cell lung cancer whose tumors are ALK-positive. But now it's on its way to snagging a speedy nod in another group of NSCLC patients, too.
The industry often points to the high cost of R&D for new lifesaving drugs as the main factor behind prices, but a deep dive by the Wall Street Journal into Pfizer's pricing on breast cancer drug Ibrance finds that some drugmakers instead rely on multiyear, complex market analysis to find a price point the market will bear.
Cellectis suffered its worst day in two years on the Paris stock exchange on Monday. The 13% slump began when it became clear that a conference call held by Cellectis, Pfizer and Servier would do little more than clarify the roles of each party in their recently struck CAR-T collaboration.