Put the latest biotech news in context with this week’s Biotech Commentary report, generated by Thomson Reuters IR Advisory Services analysts. Learn about relevant clinical and regulatory news, information on partnerships and financings, notable sell-side upgrades, downgrades and price target changes, earnings recaps, and informative sector articles and videos. Read the report. Interested in getting similar commentaries on a daily basis – before the market opens and following the close? Leave a comment to let us know.
Week of May 28– June 1, 2012
Declines in biotechnology indices exceeded those in major US averages. For the week, the BTK receded 5.85% to 1382.11, and the NBI fell 4.53% to 1240.98. Each finished at the lowest levels since mid-April.
REGULATORY
Janssen Therapeutics, a division of Janssen Products, announced the FDA issued a CRL for a sNDA for an 800mg tablet of PREZISTA. PREZISTA is approved for once-daily oral administration of 800mg — two 400mg tablets — for the treatment of HIV-1 in treatment-naive and treatment-experienced adult patients with no darunavir resistance-associated mutations.
Exelixis announced on Wednesday it completed the filing of its rolling NDA with the FDA for cabozantinib as a treatment for patients with progressive, unresectable, locally advanced, or metastatic medullary thyroid cancer. Exelixis slipped 0.65% to $4.59. (more…)