22:46 , Oct 19, 2018 |  BioCentury  |  Politics, Policy & Law

CFIUS waiting game

Biotech and its investors must wait to find out how much of the industry will be caught up in the CFIUS dragnet of foreign investment in American companies, but the U.S. Treasury has given itself...
22:35 , Oct 19, 2018 |  BC Extra  |  Company News

Management tracks: AbbVie, Adverum

AbbVie Inc. (NYSE:ABBV) said EVP and CFO William Chase will retire in mid-2019. Effective immediately, Chase becomes EVP of finance and administration until his retirement and VP and Controller Robert Michael will succeed Chase as...
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...
18:02 , Oct 19, 2018 |  BC Week In Review  |  Company News

Express Scripts adds Aimovig, Emgality to new value-based migraine program; excludes Ajovy

Express Scripts Holding Co. (NASDAQ:ESRX) will include two of three FDA approved migraine prevention drugs in its value-based program for migraine, which it unveiled Oct. 17. The PBM gave the nod to Aimovig erenumab-aooe from...
23:16 , Oct 17, 2018 |  BC Extra  |  Company News

Express Scripts adds Aimovig, Emgality to new value-based migraine program; excludes Ajovy

Express Scripts Holding Co. (NASDAQ:ESRX) will include two of three FDA approved migraine prevention drugs in its value-based program for migraine, which it unveiled Wednesday. The PBM gave the nod to Aimovig erenumab-aooe from Amgen...
04:17 , Oct 13, 2018 |  BioCentury  |  Product Development

Trevena goes for MOR than morphine

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee meeting on pain candidate oliceridine from Trevena Inc. gave the agency little reason to reverse its skepticism about the molecule’s benefits and risks. But it did leave...
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...
19:30 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

Advisory panel narrowly rejects olicerideine for acute pain

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 8-7 against recommending approval of oliceridine (TRV130) from Trevena Inc. (NASDAQ:TRVN) to manage moderate to severe pain in adults for whom IV opioids are warranted. Panelists who...
22:05 , Oct 11, 2018 |  BC Extra  |  Company News

Advisory panel narrowly rejects oliceridine for acute pain

FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 8-7 against recommending approval of oliceridine (TRV130) from Trevena Inc. (NASDAQ:TRVN) to manage moderate to severe pain in adults for whom IV opioids are warranted. Panelists who...
20:07 , Oct 11, 2018 |  BC Extra  |  Company News

Management tracks: Former Baxalta exec joins VisionGate; Carrick names Golumbeski chair

Cancer company VisionGate Inc. (Phoenix, Ariz.) hired John Glasspool as chief operating and strategy officer, a newly created position. He was EVP and head of corporate strategy and customer operations at Baxalta Inc., which Shire...