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The House of Representatives approved the 21st Century Cures Act by a vote of 344 to 77 on July 10, moving focus to the Senate where efforts have begun to develop comparable legislation. Read More
Relying on a U.S. Supreme Court precedent involving Actavis, the Third Circuit Court of Appeals ruled June 26 that patent settlements in pay-for-delay cases can face antitrust scrutiny even if they do not include cash. Read More
The Federal Circuit Court of Appeals has ruled that two of The Medicines Company’s patents for its anticlotting drug Angiomax are invalid — a win for Hospira, which is planning a generic version of the treatment. Read More
Early notice of production shutdowns by manufacturers of life-supporting and life-sustaining drugs and biologics have allowed the FDA to avert more than 550 potential drug shortages in the last three years, the agency says in a final rule mandating early notice. Read More
The European Commission says it does not have the authority to issue compulsory licenses to allow the manufacture of generic drugs during a health emergency, noting those decisions are made by member states on an individual basis. Read More
Brazil’s antitrust watchdog has fined Eli Lilly and its local affiliate $11.7 million for filing contradictory and misleading lawsuits in Brazilian courts to maintain exclusive rights to its cancer drug Gemzar. Read More
Lawmakers in the House introduced a bipartisan bill that would prevent brand drugmakers from thwarting competition by using restricted distribution networks to deny generics and biosimilars makers access to product samples they need to obtain FDA marketing approval. Read More
Competition from generic drugs allowed European healthcare systems and patients to save more than $100 billion last year, a new report shows. Generics competition nearly doubled access to drugs across seven key therapy areas: angiotensin II antagonists, antiepileptics, antidepressants, antipsychotics, antiulcerants, cholesterol regulators and oral antidiabetics, according to an IMS Institute for Healthcare Informatics report released earlier this month. Read More