In the wake of its diabetes drug Avandia's stay of execution last week at the hands of an FDA advisory committee, GlaxoSmithKline reported a second-quarter loss on July 21, but its chief executive Andrew Witty choose to highlight progress in R&D restructuring that has generated a "tailwind" for GSK's business.
Investors tracking J&J earnings on July 20 focused attention largely on the hit to its consumer health business following recalls of certain over-the-counter medicines and the related, temporary closing of a manufacturing plant. The diversified company's pharma business also took a beating in the second quarter, which is likely to accelerate through the end of the year, as some European governments, facing daunting budget deficits, accelerated routine programs to cut drug prices.
The decade-long struggle to have one "EU" patent, valid in all EU countries after a single filing in one language, has moved a small step forward. The European Commission is proposing that only one of three official languages should be used in EU patent filings, instead of inventors paying for patents to be translated into each language spoken in all the EU countries.
A proposal from the German ministry of research to fund interdisciplinary health care and disease research centers could be a boon for the European biopharmaceutical industry, according to the German pharmaceutical industry association VFA.
The German government's Hightech-Strategy 2020 document, published July 14 in Berlin, includes proposals designed to adapt German industry to the changing global environment, foster ties between industry and academia, and give a boost to competitiveness and innovation in the pharmaceutical sector.
The UK's new "Lib-Con" coalition government has detailed plans to reshape the country's National Health Service, promising to "pay drug companies according to the value of new medicines, promote innovation, to ensure better access for patients to effective drugs and improve value for money."
It also said it would create a fund to expand access to cancer drugs.
The "chatter" between reviewers and scientists at FDA and the European Medicines Agency appears to be increasing as the two bodies move toward renewing their confidential information sharing agreement.
An extension is expected to be signed in late September, FDA said. The latest version will include all products the agency regulates. That includes tobacco, over which FDA just recently gained jurisdiction. This new agreement will remain in effect until terminated by either side, the agency said.
Perhaps the most anticipated FDA advisory committee meeting of 2010 has been the July 13-14 "rereview" of GlaxoSmithKline’s diabetes drug Avandia and particularly the drug's possible cardiovascular risks.
"The Pink Sheet" DAILY set the stage with several in-depth articles exploring key issues leading up to the meeting and now is covering the committee's actions just as closely.
Get a free download of two of our most recent articles now, by going HERE. "The Pink Sheet" DAILY will be providing continued Avandia coverage all week. Go to www.thepinksheetdaily.com to get a free trial subscription.
European Biopharmaceutical Enterprises (EBE), the biotech arm of EFPIA, has elected Marc de Garidel president. Mr de Garidel is vice-president south region of Amgen International, based in Zug, Switzerland.