BioCentury | Mar 10, 2020
Product Development

March 9 Quick Takes: A first for Boehringer’s Ofev; plus Cel-Sci’s COVID-19 therapy, Sinopharm, AZ, Urovant, Hengrui, Trevena, and Tetra-Shionogi

Boehringer’s Ofev approved as first therapy for lung scarring disease  FDA approved Ofev nintedanib from Boehringer Ingelheim GmbH as the first therapy for chronic fibrosing interstitial lung diseases; the NDA had received Priority Review. The...
BioCentury | Feb 29, 2020
Management Tracks

Brandicourt joins Alnylam's board: plus Bayer, Jazz, Halozyme, Arena, Aurinia, Adverum, Neoleukin, Centogene, Epirium, Insilico, Nouscom, Eloxx, Nordic, Summit,

RNAi therapeutics company Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said Olivier Brandicourt will join its board. Brandicourt, who retired as CEO of Sanofi (Euronext:SAN; NASDAQ:SNY) last year, also plans to join Blackstone Group as a senior adviser....
BC Extra | Aug 28, 2019
Company News

Aug. 28 Company Quick Takes: Amgen to appeal Repatha ruling and EcoR1 buys Woodford’s stake in Prothena; plus DarwinHealth-Celgene, CRISPR IP, Trevena and Shink

Repatha patents invalid, court finds  Amgen Inc. (NASDAQ:AMGN) said it will appeal after a federal court found that its patents covering anti-PCSK9 mAb Repatha evolocumab are invalid on the basis of lack of enablement. The...
BC Extra | Jun 28, 2019
Company News

Management tracks: Gottlieb joins Pfizer board; plus Adaptimmune, Xencor, Arcus and more

Pfizer Inc. (NYSE:PFE) appointed former FDA Commissioner Scott Gottlieb to its board. Gottlieb is joining the board's regulatory and compliance and science and technology committees. Since leaving the FDA in early April, Gottlieb returned to...
BC Week In Review | Nov 9, 2018
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...
BC Extra | Nov 2, 2018
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...
BioCentury | Oct 13, 2018
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...
BC Week In Review | Oct 12, 2018
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...
BC Extra | Oct 11, 2018
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...
BC Extra | Oct 9, 2018
Company News

FDA reviewers doubt benefits of Trevena's analgesic over morphine

Trevena Inc. (NASDAQ:TRVN) was off $1.91 (64%) to $1.07 on Tuesday after FDA reviewers expressed doubts that the company’s Olinvo oliceridine (TRV130) offered a benefit over morphine, according to briefing documents released ahead of a...
Items per page:
1 - 10 of 112
BioCentury | Mar 10, 2020
Product Development

March 9 Quick Takes: A first for Boehringer’s Ofev; plus Cel-Sci’s COVID-19 therapy, Sinopharm, AZ, Urovant, Hengrui, Trevena, and Tetra-Shionogi

Boehringer’s Ofev approved as first therapy for lung scarring disease  FDA approved Ofev nintedanib from Boehringer Ingelheim GmbH as the first therapy for chronic fibrosing interstitial lung diseases; the NDA had received Priority Review. The...
BioCentury | Feb 29, 2020
Management Tracks

Brandicourt joins Alnylam's board: plus Bayer, Jazz, Halozyme, Arena, Aurinia, Adverum, Neoleukin, Centogene, Epirium, Insilico, Nouscom, Eloxx, Nordic, Summit,

RNAi therapeutics company Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) said Olivier Brandicourt will join its board. Brandicourt, who retired as CEO of Sanofi (Euronext:SAN; NASDAQ:SNY) last year, also plans to join Blackstone Group as a senior adviser....
BC Extra | Aug 28, 2019
Company News

Aug. 28 Company Quick Takes: Amgen to appeal Repatha ruling and EcoR1 buys Woodford’s stake in Prothena; plus DarwinHealth-Celgene, CRISPR IP, Trevena and Shink

Repatha patents invalid, court finds  Amgen Inc. (NASDAQ:AMGN) said it will appeal after a federal court found that its patents covering anti-PCSK9 mAb Repatha evolocumab are invalid on the basis of lack of enablement. The...
BC Extra | Jun 28, 2019
Company News

Management tracks: Gottlieb joins Pfizer board; plus Adaptimmune, Xencor, Arcus and more

Pfizer Inc. (NYSE:PFE) appointed former FDA Commissioner Scott Gottlieb to its board. Gottlieb is joining the board's regulatory and compliance and science and technology committees. Since leaving the FDA in early April, Gottlieb returned to...
BC Week In Review | Nov 9, 2018
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...
BC Extra | Nov 2, 2018
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...
BioCentury | Oct 13, 2018
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...
BC Week In Review | Oct 12, 2018
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...
BC Extra | Oct 11, 2018
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...
BC Extra | Oct 9, 2018
Company News

FDA reviewers doubt benefits of Trevena's analgesic over morphine

Trevena Inc. (NASDAQ:TRVN) was off $1.91 (64%) to $1.07 on Tuesday after FDA reviewers expressed doubts that the company’s Olinvo oliceridine (TRV130) offered a benefit over morphine, according to briefing documents released ahead of a...
Items per page:
1 - 10 of 112