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...
03:04 , Jun 30, 2018 |  BioCentury  |  Finance

Eyes on launches

The annual summer slowdown isn’t restricted to just the stock market this year, as the clinical catalyst calendar also appears to be on holiday in 3Q18. Buysiders are therefore turning their attention to a spate...
18:31 , May 25, 2018 |  BC Week In Review  |  Clinical News

FDA reviewing AcelRx's pain candidate

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) said FDA accepted for review an NDA for Dsuvia sufentanil sublingual tablet (ARX-04) to treat moderate to severe acute pain in medically supervised settings. Its PDUFA date is Nov. 3. The...
20:17 , May 24, 2018 |  BC Extra  |  Company News

FDA reviewing AcelRx's pain candidate

AcelRx Pharmaceuticals Inc. (NASDAQ:ACRX) said FDA accepted for review an NDA for Dsuvia sufentanil sublingual tablet (ARX-04) to treat moderate to severe acute pain in medically supervised settings. Its PDUFA date is Nov. 3. The...