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A federal judge has dismissed conspiracy claims against four generic drugmakers and a brand firm in a class-action lawsuit that alleges the companies colluded to keep generic versions of Cephalon’s wakefulness drug Provigil off the market. Read More
A federal judge has tossed out Novartis’ lawsuit against generic firm Alvogen’s challenge to its dementia treatment Exelon Patch, claiming the brand firm failed to show the generic product contained a patented antioxidant. Read More
French drugmaker Servier and five generics firms are facing roughly $580 million in fines from European antitrust regulators over an alleged pay-for-delay scheme. Read More
Drugmakers hoping to market generic and biosimilar products quickly in Brazil should pair up with the corresponding branded firms to facilitate the application process, says an updated rule that aims to speed generic approvals. Read More
Manufacturers of generic versions of cholesterol drugs Darvocet and Darvon can’t be held liable for not changing their labels to note safety warnings without prior FDA approval, an appeals court has ruled, further entrenching generic drugmakers’ protections from failure-to-warn and other lawsuits. Read More
A key European panel has recommended approval for Eli Lilly and Boehringer Ingelheim’s biosimilar of Sanofi’s blockbuster long-acting insulin drug Lantus, creating a potential threat to the French drugmaker’s multi-billion dollar product. Read More
The FDA has laid out new goals for speeding up its handling of regulatory submissions from generics makers that eventually call for 90 percent of some prior approval supplements to be acted on within six months and ANDA amendments to be acted on within 10 months. Read More
Avanir Pharmaceuticals has settled with generic firm Ranbaxy over its bid to produce a version of the brand manufacturer’s Nuedexta, the first drug approved in the U.S. to treat pseudobulbar affect (PBA). Read More
Massachusetts has become the eighth state to pass a law enabling pharmacists to substitute a biosimilar for a branded biological product, earning praise from industry groups that believe such state laws are vital to biosimilar adoption. Read More
The U.S. Patent and Trademark Office’s recently established patent review board has received what appears to be its first challenge to a drug patent covering a business practice rather than a drug’s attributes. Read More
The FDA would require biosimilars to carry the same name as their reference drug counterparts under a proposal being pushed by healthcare payers and GPhA. Read More
Generic drugmaker Mylan agreed to pay Abbott Labs $5.3 billion in stock to acquire part of its international generic drug business in a deal that vastly spreads the geographic reach of the Pennsylvania-based firm. Read More