On the heels of new guidelines casting doubts on a much-hyped new class of cholesterol drugs, the FDA said it would not demand long and costly outcomes trials before approving PCSK9 treatments from the likes of Amgen, Sanofi and Regeneron, clearing the way for treatments expected to rake in up to $3 billion a year.
Tantalized by various megablockbuster projections for the PCSK9 field of cholesterol drugs, Pfizer has mapped out one of the most ambitious late-stage programs in the industry for RN-316.
Sanofi and Regeneron have rolled out promising Phase III data on their cholesterol drug alirocumab, which handily breezed by Merck's Zetia in lowering bad LDL cholesterol. The partners are in a high-stakes race to win the first regulatory approval for a PCSK9 inhibitor.
In an industry like pharma, you're only as good as your next big Phase III study. And hopes are running very, very high for the first round of late-stage results on the PCSK9 drug alirocumab from Sanofi and Regeneron.
After partners Regeneron and Sanofi announced more than 10 late-stage studies last year, Regeneron revealed plans Tuesday to take a shot at a trial to test less frequent dosing of the experimental therapy.
With a new blockbuster drug and more potential hits in development, Regeneron Pharmaceuticals has been successful long enough for top executives to consider the challenges of keeping the entrepreneurial culture behind the R&D streak alive. Read more >>
Just a few months after Amgen execs lamented a big Asian gap in their global strategy, the Big Biotech company has joined hands with Astellas to set up a new joint venture in Japan. Amgen is contributing 5 experimental-stage programs to the JV, including their late-stage anti-PCSK9 program for the cholesterol drug AMG-145.
Regeneron Pharmaceuticals notified investors today that its longtime partner Sanofi is moving to snap up a big chunk of its stock.
The Thousand Oaks, CA-based biotech powerhouse made an unexpected move in December to buy the pioneering genomics company deCODE for $415 million. Today R&D chief Dr. Sean Harper further explained how the capabilities of the company fit within the broader strategy at Amgen to be more discerning about which research programs to pursue.
The Medicines Co. has bought into one of the most exciting cardio drug targets in biotech, licensing a PCSK9 candidate from Alnylam Pharmaceuticals for $25 million upfront and up to $180 million in milestones, the companies said today.