March 16 Quick Takes: FDA raises efficacy questions for DBV allergy therapy; plus Novo, Provention, UCB, Pfizer-EMD Serono, Zai, AcelRx-Tetraphase, Medivir-Tan

DBV expects delay for peanut allergy product
DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) said the Aug. 5 PDUFA date for its peanut allergy therapy may be extended as FDA has raised questions on the long-term efficacy of Viaskin and its patch-site adhesion. FDA canceled the advisory committee meeting scheduled for May 15 to discuss the BLA and may require an additional data submission, DBV said. The company lost $0.63 (11%) to $5.26 in the U.S. Monday, and fell an additional $3.01 (57%) to $2.25 during after-hours trading.

Novo ‘pauses’ hemophilia A and B studies
Novo Nordisk A/S (CSE:NOVO B; NYSE:NVO) disclosed three cases of non-fatal thrombotic events in its Phase III explorer 7 and 8 studies, both evaluating concizumab as prophylactic treatment for hemophilia A and B. It said it will “pause” the parallel trials -- one in patients who have developed inhibitors to clotting factors and the other in patients who haven’t -- as well as a Phase II study for hemophilia A. The company and an independent data monitoring committee are determining whether the trials evaluating the anti-TFPI mAb may proceed...