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European regulators have granted Astellas’ oncology drug Xtandi a new indication for men with pre-chemotherapy prostate cancer who have failed androgen deprivation therapy, putting it in direct competition with Johnson & Johnson’s Zytiga. Read More
Ranbaxy is fighting to reclaim its first-filer generic exclusivity on AstraZeneca’s blockbuster heartburn drug Nexium with a lawsuit challenging the FDA’s recent decision to rescind tentative ANDA approval for the therapy over manufacturing violations. Read More
Manufacturers that adapt existing drugs and biologics to treat rare diseases could receive an additional six months of market exclusivity for the original indication under a new bipartisan House bill. Read More
The FDA has proposed criteria for how an ANDA can receive an expedited review under the “first generic” review prioritization category, a move the agency hopes will ease industry confusion over the generic drug incentive. Read More
The FDA has approved a new indication for Sanofi’s tuberculosis drug Priftin in combination with isoniazid to treat latent tuberculosis infection (LTBI). Read More
The UK’s healthcare cost watchdog is recommending coverage of Roche’s cancer drug Gazyvaro with chlorambucil for some chronic lymphocytic leukemia patients, reversing its earlier rejection of the combo therapy over concerns with the manufacturer’s clinical- and cost-effectiveness models. Read More
The FDA has rejected Teva’s seventh citizen petition calling for the agency to boost its scrutiny of any ANDA seeking to make a generic version of the Israeli firm’s blockbuster multiple sclerosis drug Copaxone. Read More
A pan-European health technology assessment body has recommended that EU cost-effectiveness evaluators compare new pharmaceuticals against the most relevant standards of care, in a new framework to harmonize different member states’ individual guidelines on making coverage decisions. Read More
The European Medicines Agency last week approved Boehringer Ingelheim’s lung cancer drug Vargatef for treating non-small cell lung adenocarcinomas. Read More
Endo and Bayer are suing generics maker Perrigo’s subsidiary Paddock Laboratories over its patent challenge to the brand firms’ testosterone replacement therapy Aveed. Read More
The European Medicines Agency has approved AstraZeneca’s Duaklir Genuair as a maintenance treatment for patients with chronic obstructive pulmonary disease. Read More
Manufacturers that adapt existing drugs and biologics to treat rare diseases could receive an additional six months of market exclusivity for the original indication under a new bipartisan House bill. Read More