Some of the leaders in the frenzied late-stage race to develop a PCSK9 drug watched their stock prices stumble on Friday afternoon as word of the FDA's concern about potential neurocognitive side effects in the cholesterol drug class ripped through Twitter.
Reaping the benefits of deep-seated R&D reorganization, GlaxoSmithKline had the industry's best 6-year run of FDA nods for new drugs, according to EvaluatePharma, leading its competitors by a wide margin and leaving approval-starved outfits like Eli Lilly and Merck in the dust.
Back in November, the GAVI Alliance added inactivated poliovirus vaccines to the list of products it makes available in the world's poorest countries. And with the conclusion of its tender process, UNICEF is adding its backing: The children's fund has struck a deal with Sanofi to supply the vaccine to GAVI-supported countries for as little as $1 per dose.
Sales of Sanofi's rare-disease treatment Kynamro, approved last January, got off to a slow start, but that situation shouldn't persist now that the French drugmaker's Genzyme unit has beefed up its sales force.
It turns out the corruption probe in China wasn't Sanofi's only recent bribery investigation. A German court convicted two former employees of bribery 10 months ago and slapped the French drugmaker with a €28 million ($39 million) fine--news that's just now coming to light thanks to a simplified German legal process that allows courts to try some crimes without a courtroom trial.
The earnings reports for the biggest of Big Pharma are all in. Bayer reported last week, making it possible to see how they stacked up as they came into the new year. There are no big surprises....
There's no word on the upfront, but Sanofi has committed to pay up to $198 million in milestones if the portfolio delivers an approved therapy that can be used to treat hyperphosphatemia, a condition characterized by elevated levels of phosphate in the blood of patients with end stage renal disease and other forms of chronic kidney disease.
Last week research firm GlobalData tipped the hepatitis B vaccine market to top $1 billion by 2022, with sales of Sanofi's Hexyon driving the sector's modest growth. Dynavax hopes to claim a slice of the market too, but its hepatitis B vaccine received another blow this week.
Shire has garnered FDA approval to make its orphan drug Vpriv at a plant in Lexington, MA. That means it now has approval at two plants in the U.S. to manufacture the treatment for type 1 Gaucher disease.
What will Sanofi do with its cash? That's the question now that L'Oreal seems happy to remain the French drugmaker's largest shareholder. Absent the need to hoard cash to buy back L'Oreal shares, at least for now, Sanofi can use that money for something else.