Sanofi's new diabetes drug hit a setback in Germany. The country's increasingly strict pricing regulators say Lyxumia delivers "no additional benefit" compared with existing drugs. If the decision sticks, then Sanofi would lose the power to price Lyxumia at a brand-name premium.
On Tuesday, the SEC filed civil complaints against two brothers accused of buying stock based on secret knowledge of the then-upcoming takeover--the 8th case the Commission has brought against insider trading connected to that deal, it says.
The FDA two days ago gave its approval to Sanofi's Fluzone Quadrivalent, a 4-1 influenza vaccine, and now the estimates on the revenue upside are starting to roll in. GlobalData says they look very promising.
The 2013-14 flu season is set to be the most closely watched in years. In February, FDA cleared the use of quadrivalent vaccines which protect against two A and two B strains. GlaxoSmithKline and AstraZeneca began gearing up, and Sanofi will now join them too.
Lemtrada, Sanofi's "new" drug for multiple sclerosis, helps demonstrate just how plagued the drug-development process can be, with a series of false starts and sudden stops as it was handed off from one company to the next. Today, Reuters ' Ben Hirschler chronicled the 25-year R&D odyssey, which is expected to be capped soon with a European approval followed soon after by an FDA decision.
With competition fierce in the diabetes category, Sanofi is pushing its franchise in multiple directions, issuing new devices, new drugs and new markets to secure its position.
As a major medical meeting brings the spotlight to new diabetes drugs this month, Sanofi has begun reaching out to the media to secure center-stage status for data on its new therapies. The French drug giant has a next-generation version of its best-selling insulin drug Lantus as well as a combo therapy that have implications for its future in the market.
Sanofi is gearing up for commercial production at an insulin plant in Russia which it bought in 2010 from a Polish company.
Now that we know that a single immunotherapy can slow cancer, it stands to reason that two can do better. And that's what investigators say happened when they combined Sanofi's white blood cell booster GM-CSF with Bristol-Myers Squibb's Yervoy.
A universal flu vaccine is the holy grail of influenza immunizations. The yearly process of making educated guesses about the upcoming flu season would end, replaced by a vaccine for many of the strains. It is a massive challenge, but one that Sanofi and others have taken up.