01:35 , Mar 9, 2019 |  BioCentury  |  Regulation

Gottlieb’s exit interview

FDA Commissioner Scott Gottlieb sat down with BioCentury after announcing his resignation to discuss his approach to promoting medical product innovation, the importance of strategic communications, and how a reorganization will bring FDA drug reviews...
23:46 , Jan 15, 2019 |  BC Extra  |  Company News

Management tracks: Immunocore gains second ex-AZ exec

Immunocore Ltd. (Abingdon, U.K.) said it hired David Berman in September as head of R&D. Berman was SVP and head of immuno-oncology at AstraZeneca plc (LSE:AZN; NYSE:AZN), and before that was head of early stage...
00:23 , Jan 12, 2019 |  BioCentury  |  Finance

We all fall down

After an exuberant third quarter that put biotech indexes near their 2015 highs, all market cap tiers fell in 4Q18, eliminating the first nine month’s gains and losing $291.2 billion in aggregate value. Median losses...
17:31 , Nov 9, 2018 |  BC Week In Review  |  Clinical News

FDA approves AcelRx, Coherus, Pfizer Products, rebuffs Trevena's Olinvo

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Nov. 2, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN). Coherus was up...
21:15 , Nov 2, 2018 |  BC Extra  |  Company News

FDA approves AcelRx, Coherus, Pfizer products, rebuffs Trevena's Olinvo

FDA approved products from Coherus Biosciences Inc. (NASDAQ:CHRS), AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) and Pfizer Inc. (NYSE:PFE) on Friday, but issued a complete response letter to an NDA from Trevena Inc. (NASDAQ:TRVN). Coherus was up $0.70...
19:25 , Nov 2, 2018 |  BC Extra  |  Company News

Gottlieb justifies approval of Dsuvia, a new opioid

In the wake of calls for FDA to reject a new opioid analgesic, Commissioner Scott Gottlieb Friday explained the agency’s decision to approve Dsuvia sufentanil sublingual tablet by detailing the niche the drug fills and...
18:25 , Oct 19, 2018 |  BC Week In Review  |  Clinical News

FDA panel votes in favor of AcelRx's pain candidate

FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 that the benefit-risk profile of Dsuvia sufentanil sublingual tablet (ARX-04) from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) supports its approval to manage moderate to severe acute pain...
22:20 , Oct 12, 2018 |  BC Extra  |  Company News

FDA panel votes in favor of AcelRx's pain candidate

FDA's Anesthetic and Analgesic Drug Products Advisory Committee voted 10-3 that the benefit-risk profile of Dsuvia sufentanil sublingual tablet (ARX-04) from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) supports its approval to manage moderate to severe acute pain...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
22:43 , Sep 13, 2018 |  BC Week In Review  |  Clinical News

Advisory committee meeting Oct. 12 to discuss NDA for Acelrx's Dsuvia

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee will meet Oct. 12 to discuss an NDA from AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) for Dsuvia sufentanil sublingual tablet (ARX-04) to manage moderate to severe acute pain severe...