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Author Archives: Clark Herman
The FTC's Beef with Pay For Delay: What's the Fuss?
Yesterday, the Supreme Court heard arguments on the matter of pay-for-delay settlements between patent holders and generic firms. The Federal Trade Commission (FTC) hopes to overturn the 11th federal circuit’s ruling that such settlements are not anti-competitive on the grounds that these settlements amount to a restraint of trade under the commerce clause of the [...]
Posted in IP, Legal, Market Access, Regulatory Tagged Actavis, Andro-Gel, FTC, Hatch-Waxman, Supreme Court 1 Comment
AstraZeneca's R&D Trimdown, Points to Shift in The Way Big Pharma Invents
AstraZeneca’s decision to cut 5,050 jobs by 2016 and cease R&D operations at its Alderley Park, UK facility has many wondering where CEO Pascal Soriot plans to take the company. The opening of a new $500 million facility in Cambridge is at once a consolation prize for the UK government’s efforts to placate a skittish [...]
Refilling the Antibiotic Pipeline: How to Lead the Horse to Water?
Last week, the United States Center for Disease Control (CDC) and Britain’s Chief Medical Officer issued separate warnings about the urgent problem of antibiotic resistance in infectious diseases. Given industry’s general lack of interest in developing new antibiotics to address this problem, the warnings indicate that a discussion is needed around which incentives and regulatory [...]
Posted in FDA, Global, Market Access, R&D, Regulatory, Safety, Strategy, pricing Tagged Antibiotics, CDC, GAIN Act, IDSA, LPAD 1 Comment
Emerging Countries' R&D: A Contest, but No Wipe Out
Emerging country markets are widely viewed as Big Pharma’s ace in the hole to replace declining rates of innovation in the US and Europe, with numerous studies claiming the BRICK nations (the ‘K’ is from South Korea) are at the center of a revolutionary global shift in the source points for new ideas — what [...]
Posted in Emerging Markets, Global, IP, R&D Tagged BRIC, BRICK countries, Emerging Markets, R&D 2 Comments
Mapping Opportunities with the Non-Physician Prescriber