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Biotechnology industry leaders are telling House lawmakers that proposed legislation allowing the FDA to approve follow-on biologics should include clear and sound patient safety provisions.
Weeks after congressional leaders convened on Capitol Hill to discuss a bill aimed at stopping anticompetitive agreements between generic and brand drug firms, more legislation has emerged targeting another much-criticized practice — launching authorized generics.
A panel of drug industry representatives presented their views on the effects of reverse-payment deals before federal lawmakers at a Senate hearing called to consider proposed legislation that could stop the practice of paying generic drug companies to limit market competition.
The FTC has filed an amicus brief asking a federal appeals court to rehear a case against AstraZeneca and Barr Laboratories that charged that the drugmakers violated antitrust laws with their patent settlement over AstraZeneca's breast cancer drug Nolvadex.
Generic drugmakers were dealt another setback in their fight against authorized generics after a federal appeals court ruled that federal law does not prohibit the holder of an approved new drug application (NDA) from marketing its own “brand-generic” version of the drug during a generic firm’s 180-day exclusivity period.
Noven Pharmaceuticals’ efforts to bring a generic version of Johnson & Johnson’s (J&J) Duragesic transdermal pain patch to market are being deliberately blocked by a “suspicious” string of citizen petitions, the company claimed in a recent filing with the FDA.
Proposed changes to Canada’s drug regulations to limit the brand practice of “evergreening” patents on pharmaceutical products are receiving a mixed response from Canada’s generic drug industry.
The generic drug industry’s key provision in last year’s Medicare drug benefit has not stopped brand firms from using an effective tactic to delay generic competition, a patent attorney says.
Generic firm Mylan Pharmaceuticals has refiled its lawsuit against the FDA over the agency’s stance on authorized generics — and added several antitrust claims as well as two new defendants