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Drugmakers are facing tougher hurdles in getting new cancer drugs covered in the UK, according to a U.S industry trade group. But some observers and UK government officials counter that the majority of these expensive treatments are still being widely reimbursed, even if they come with some restrictions. Read More
Massachusetts-based Cubist Pharmaceuticals is suing Fresenius Kabi over its proposed generic version of Cubist’s profitable antibiotic Cubicin. Read More
The FTC gave generics makers a boost last month in their fight to stop brand drugmakers from using REMS restrictions to block access to sample drugs the generics industry needs to prepare ANDAs. Read More
SAN DIEGO — The FDA is racing to beat a fall deadline to release a string of new guidances for generics makers that it hopes will head off a potential torrent of rejected submissions. Read More
Canadian generics maker Apotex’s plant in Bangalore, India, has rampant problems with data manipulation, including continuously retesting batches until the desired result is achieved, the FDA charges in a warning letter. Read More
Generics maker Ranbaxy has the green light to launch an exclusive version of Novartis’ blockbuster hypertension drug Diovan, a move that comes nearly two years after the drug lost patent protection. Read More
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