An award of $76 million may not sound like much in the big-dollar world of pharma, but for a branded drug company, it always feels good to win one against a generic drugmaker that has jumped the gun with a generic. That is how much a court says AstraZeneca should be paid by Apotex.
Gilead Sciences' new hepatitis C drug sofosbuvir won preliminary backing from European regulators on Friday, with marketing approval expected to follow soon. The FDA is expected to clear the drug for take-off Dec. 8, if not sooner. All good for the California-based drugmaker. But there's a battle over sofosbuvir brewing in India.
Teva's best-selling drug Copaxone will face generic competition next year, fully 18 months before the company had anticipated. That's gonna hurt. How much will it hurt? An Israeli publication thinks it has Teva's answer to that--a 42% cut to the drug's sizable profits.
The whole pay-to-delay issue has gotten a lot of attention in the U.S., particularly with the U.S. Supreme Court this year making it easier for regulators and payers to attack those deals. But Europe also thinks the deals tend to stink for patients and government payers, and it has begun issuing fines to alleged violators. Next up looks to be Novartis and Johnson & Johnson.
The European Medicines Agency Friday granted Tecfidera just what Biogen has been waiting for--a "new active substance" designation, paving the way to even greater sales for the hot product.
Indian officials must have been glad to hear from GlaxoSmithKline CEO Andrew Witty. During a trip to the country, Witty told Indian media that the country's policies on pricing and patents are understandable, even reasonable, though they may pain the pharma industry.
Teva Pharmaceutical Industries took another shot at fending off early generic competition for its top-selling drug Copaxone. But the U.S. Supreme Court didn't cooperate. The court refused to stay a Federal Circuit ruling that would allow generic rivals onto the market next May, 18 months earlier than Teva had anticipated.
In a way, the coming year isn't a big one for patent expirations. The total amount of sales jeopardized by patent expirations is $34 billion. That's more than the $28 billion this year, but...
AstraZeneca has been fighting a rearguard action against Hanmi Pharmaceutical's modified version of Nexium that threatens one of the few strong revenue sources AstraZeneca has right now. Japan's Hanmi is back on the offensive after a U.S. federal court lifted a stay on the the launch of its product.
Nexium has won a reprieve from looming competition--if only temporarily. A U.S. appeals court ordered Hanmi Pharmaceutical to hold off on selling its modified version of AstraZeneca's blockbuster stomach drug to give the court time to weigh patent-infringement claims.