Amgen just lost a key regulatory race. Armed with a handy FDA shortcut voucher, Regeneron and its Big Pharma partner Sanofi announced today that the agency has accepted their application for the powerful new PCSK9 cholesterol drug alirocumab and set a priority deadline of July 24 for their marketing decision. If they get a quick green light, as many analysts expect, their decision to buy the priority review voucher will be rewarded with first-mover advantage with U.S. payers as Amgen sits out an FDA game clock that ends August 27.
Sanofi may not have its next CEO figured out yet, but it's worked out what it's going to pay departed helmsman Chris Viehbacher. The former chief exec will take home €2.96 million in severance following his abrupt dismissal last fall, plus noncompete pay and 2014 incentive pay.
With the effectiveness of this year's influenza vaccines so low as to have made most of this year's vaccinations pointless, the industry is searching for avenues to abbreviate the 6-month development and manufacturing process to deal better with the kinds of virus mutations that came into play this year.
Another purported Sanofi CEO candidate has publicly knocked himself off the list. Takeda chief operating officer and CEO-in-waiting Christophe Weber says he's not interested in the job. That makes two top pharma execs who've rebuffed the French drugmaker.
Law firms are hoping to find plaintiffs for shareholder lawsuits against Sanofi. Potential claims focus on an alleged illegal kickback strategy for the company's diabetes franchise, designed to boost sales.
Sanofi's lawyers must be watching PR Newswire with their fingers crossed. A handful of hopeful law firms are scouting for lead plaintiffs in shareholder lawsuits against the French drugmaker, citing a string of bad news during the second half of last year.
Catalent has signed a collaboration deal with pharma giant Sanofi, lending out its proprietary approach to crafting antibody-guided treatments.
At Sanofi, 72% of its drugs under development are biologics and half of those are monoclonal antibodies (mAbs). But instead of building a new plant right now, the French drugmaker will lean on Boehringer Ingelheim for additional mAb capacity.
Sanofi and Regeneron are hard at work on a number of promising monoclonal antibodies, but Sanofi needs more manufacturing capacity to produce them. Instead of building its own like some of its peers, the French company has struck a deal to tap into a Boehringer Ingelheim plant in Germany.
When the JP Morgan Healthcare Conference rolls around, it's always a case of so much news, so little time (and space). So, we're collecting some of the bigger stories here.