Monday, August 03, 2009

While You Were Vacationing

If you've been away for a few days, like some of us have, we hope this regulatory- and deal-news heavy WYW whips you back into shape right quick.

  • Nycomed said this morning it was buying central and eastern European rights to 20 generics from Sanofi-Aventis and Zentiva.
  • Purdue licensed US rights (and a North American option) to Trancept's Intermezzo (zolpidem) back-to-sleep treatment, the companies said on Sunday. Transcept gets $25 million up-front and a potential near-term approval milestone of $30 million, depending on approval timing (PDUFA date is in October 2009). The biotech will also receive up-to-mid-20%s royalties and an option to co-promote the drug to psychiatrists in exchange for a larger slice of royalties from these specialist sales.
  • Will Novartis' Prexige lead a personalized-medicine-enabled comeback for Cox-2 inhibitors? Bloomberg reports.
  • FDA gives a surprising "no" to Savient's gout treatment Krystexxa in a complete response letter; company says it will refile next year. An advisory committee had recommended 14-1 for approval. NYT has the story here.
  • Avastin has been approved in combination with interferon alfa for metastatic renal cell carcinoma, says Genentech.
  • Shire said this morning that its first Phase III trial of velaglucerase looked good and that FDA was on board with the drug's treatment protocol in type 1 Gaucher disease. The company has begun its rolling NDA under FDA's fast track system; the regulator has acted recently to speed up review of Gaucher treatments anticipating a Cerezyme shortage thanks to Genzyme's plant troubles.
  • The New York Times' 40 Years War series continues with a look at how difficult it is to recruit patients for cancer studies.

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