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Pharma news in brief

Our weekly round-up of news affecting the industry
ITC backs Roche over anaemia drug
The International Trade Commission (ITC) has upheld a previous decision that Roche can continue to import its drug for renal anaemia, Mircera, into the US for use in clinical trials. Biotech firm, Amgen, alleges that the novel continuous erythropoietin receptor activator (CERA) infringes its US patents for its erythropoietin products. ìWe want to offer doctors and patients in the US the choice of a novel medicine that has been created to allow longer dosing intervals up to every four weeks - something that currently does not exist in the US,î said William Burns, CEO of Roche's pharma division.

FDA and industry talking over user fees
US regulator, the Food and Drug Administration (FDA), is holding negotiations with the pharmaceutical industry over user fees to fund the agency's drug review process. The arrangement, renegotiated every five years, usually encourages concession from both sides. Reports from the US suggest the agency is likely to win extra funding in return for concessions. Each time the arrangement has been renewed, the FDA has gained extra funding. In 2002, the FDA agreed to a number of changes, including a new deadline for the agency to respond to companies' requests for meetings about drug applications.

Pfizer wins Norvasc patent challenge
A US Federal court in North Carolina has upheld a patent covering the active ingredient in Norvasc, Pfizer's top-selling hypertension drug. The patent had been challenged by generics firm, Synthon. Judge James Beaty ruled that the patent is valid and infringed by Synthon's generic product. The decision, which is subject to appeal, prohibits Synthon from launching its version (amlodipine besylate) until September 2007. ìWe will continue to defend against any patent challenges that seek to undermine the incentives established for bringing innovative medicines to patients,î said Pfizer's general counsel, Allen Waxman.

Acumen launches hospital rep course
Consultancy, Acumen TMC, has launched its new Intensive Hospital Coaching (IHC) programme and website. The programme delivers one-to-one coaching in working hospitals for medical reps of all levels of experience and was developed to provide training support in secondary care key opinion leader development, product endorsement, formulary inclusion, as well as general development, productivity and effectiveness of reps in hospitals. Details can be found at www.acumen-tmc.co.uk

30th September 2008

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