The FDA has issued AstraZeneca's least favorite form of draft guidance--the kind that helps other drugmakers develop copies of a blockbuster seller.
Two union funds are suing Novartis, claiming that the Swiss drugmaker used "sham" patent-infringement claims to delay a generic version of its blockbuster leukemia drug Gleevec. Though just the latest in a series of legal battles over drug patent settlements, it's the first attempt by purchasers to block one of those settlements, the plaintiffs' lawyers said.
Eli Lilly scored a victory in its patent battle for lung cancer blockbuster Alimta in Europe, as the Court of Appeal in London ruled against Actavis' plan to market copycat versions of the med.
Things appear to be going pretty smoothly for serial dealmaker Valeant since its failed bid for Allergan in November. The Canadian pharma bounced back with two deals earlier this year and is rumored to have another one in the works, helping it deliver on its goal of expanding into high-growth markets to become one of the world's top 5 drugmakers by 2016. But Valeant's M&A binge could be taking its toll on the company, even as it continues to ink new deals and score points with investors.
It's been a long legal road for Copaxone, and one that took yet another turn Thursday as the U.S. Court of Appeals struck down the drug's patent for the second time.
After snapping up the troubled Indian generics maker Ranbaxy Laboratories in an all-stock deal last year, Sun Pharma has sent 18 top executives at its former rival packing, including Ranbaxy President and CFO Indrajit Banerjee and VP of marketing Maninder Singh, sources told The Economic Times.
Here's something AbbVie doesn't want to hear: Industry watchers expect biosimilars for its top moneymaker Humira to be the most successful copycat biologics launched in the U.S. and Europe.
These days, companies are increasingly looking to put both branded and generic meds under one roof. And Peter Goldschmidt, the U.S. president of Novartis' Sandoz unit, doesn't know why they didn't do it sooner.
GlaxoSmithKline is already struggling with sales of aging respiratory superstar Advair, and Mylan just made its job more difficult.
Orexigen and Takeda have already had their fair share of headaches over obesity med Contrave this year after a data leak forced the pair to abandon a postmarketing heart study. Now, though, they've got a generic to fend off, and they've sued maker Actavis in order to do just that.