BioCentury | Aug 13, 2020
Regulation

Aug. 12 Quick Takes: Approvals for DMD, acute pain; plus Priority Review for Fabry, hypercholesterolemia therapies and more

...is a Nippon Shinyaku Co. Ltd. (Tokyo:4516) subsidiary.Trevena’s opioid agonist approvedFDA approved Olinvyk oliceridine from Trevena Inc....
BioCentury | Jul 25, 2020
Management Tracks

New CFOs for Generation Bio, IQVia; plus changes at Gracell, AskBio, Replimune, Triplet, Twist, Cellectis, Verrica and more

...cardiovascular and pulmonary diseases company to pursue other opportunities. Hamill was VP of finance at Trevena Inc....
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

...advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) and advanced esophageal squamous cell carcinoma. Trevena’s...
...pain therapy back under review FDA is reviewing a resubmitted NDA for Olinvo oliceridine from Trevena Inc....
...The G protein biased MOR ligand has an Aug. 7 PDUFA date (see “FDA Rebuffs Trevena’s...
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,

...Gowen is CEO of TamuroBio Inc. and founded and served as president and CEO of Trevena Inc....
BioCentury | 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

...CRISPR Case to Finally Settle the Score” ). Trevena on track for 1Q20 NDA resubmission Trevena Inc....
...severe acute pain in adults in 1Q20 (see “FDA Approves AcelRx, Coherus, Pfizer Products, Rebuffs Trevena’s...
...#), evolocumab (Generic), Repatha (Other) Amgen Inc. Broad Institute of MIT and Harvard DarwinHealth EcoR1 Capital Prothena Corp. plc Regeneron Pharmaceuticals Inc. Sanofi Trevena Inc. University...
BioCentury | Jun 28, 2019
Company News

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

...The company is repurposing combinations of approved drugs for neurodegenerative diseases. Barry Shin has joined Trevena Inc....
...chair of Mintz’s FDA practice. BioCentury Staff Adaptimmune Therapeutics plc Ambys Medicines Arcus Biosciences Inc. PDL BioPharma Inc. Pharnext S.A. Polyphor Ltd. Sante Ventures Trevena Inc. Xencor...
BioCentury | Nov 9, 2018
Clinical News

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

...Inc. (NYSE:PFE) on Nov. 2, but issued a complete response letter to an NDA from Trevena Inc....
...disease. Lorbrena is an inhibitor of ALK and c-ros proto-oncogene 1 receptor tyrosine kinase (ROS1). Trevena...
...Anesthetic and Analgesic Drug Products Advisory Committee voted 8-7 against recommending approval of Olinvo (see "Trevena...
BioCentury | Nov 2, 2018
Company News

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

...Pfizer Inc. (NYSE:PFE) on Friday, but issued a complete response letter to an NDA from Trevena Inc....
...disease. Lorbrena is an inhibitor of ALK and c-ros proto-oncogene 1 receptor tyrosine kinase (ROS1). Trevena...
...Olinvo (see "Trevena Goes for MOR than Morphine" ). Sandi Wong Biosimilar of pegfilgrastim Dsuvia Olinvo, oliceridine (TRV130) AcelRx Pharmaceuticals Inc. Trevena Inc. Coherus...
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...
...once it is in practice.” Michael Fischer, Brigham and Women’s Hospital Interactions between FDA and Trevena...
...find a partner to take that route. Oliceridine’s PDUFA date is Nov. 2. Trevena’s argument Trevena’s...
BioCentury | Oct 12, 2018
Clinical News

Advisory panel narrowly rejects olicerideine for acute pain

...comparison to morphine, and how they were viewed during Trevena's development program. At the meeting Trevena...
...for which Trevena is seeking approval. The reviewers wrote that FDA "did not agree with Trevena's...
...FDA. Trevena's clinical pipeline also includes migraine compound TRV250 and pain candidate TRV734. In August, Trevena...
Items per page:
1 - 10 of 114
BioCentury | Aug 13, 2020
Regulation

Aug. 12 Quick Takes: Approvals for DMD, acute pain; plus Priority Review for Fabry, hypercholesterolemia therapies and more

...is a Nippon Shinyaku Co. Ltd. (Tokyo:4516) subsidiary.Trevena’s opioid agonist approvedFDA approved Olinvyk oliceridine from Trevena Inc....
BioCentury | Jul 25, 2020
Management Tracks

New CFOs for Generation Bio, IQVia; plus changes at Gracell, AskBio, Replimune, Triplet, Twist, Cellectis, Verrica and more

...cardiovascular and pulmonary diseases company to pursue other opportunities. Hamill was VP of finance at Trevena Inc....
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

...advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) and advanced esophageal squamous cell carcinoma. Trevena’s...
...pain therapy back under review FDA is reviewing a resubmitted NDA for Olinvo oliceridine from Trevena Inc....
...The G protein biased MOR ligand has an Aug. 7 PDUFA date (see “FDA Rebuffs Trevena’s...
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,

...Gowen is CEO of TamuroBio Inc. and founded and served as president and CEO of Trevena Inc....
BioCentury | 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

...CRISPR Case to Finally Settle the Score” ). Trevena on track for 1Q20 NDA resubmission Trevena Inc....
...severe acute pain in adults in 1Q20 (see “FDA Approves AcelRx, Coherus, Pfizer Products, Rebuffs Trevena’s...
...#), evolocumab (Generic), Repatha (Other) Amgen Inc. Broad Institute of MIT and Harvard DarwinHealth EcoR1 Capital Prothena Corp. plc Regeneron Pharmaceuticals Inc. Sanofi Trevena Inc. University...
BioCentury | Jun 28, 2019
Company News

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

...The company is repurposing combinations of approved drugs for neurodegenerative diseases. Barry Shin has joined Trevena Inc....
...chair of Mintz’s FDA practice. BioCentury Staff Adaptimmune Therapeutics plc Ambys Medicines Arcus Biosciences Inc. PDL BioPharma Inc. Pharnext S.A. Polyphor Ltd. Sante Ventures Trevena Inc. Xencor...
BioCentury | Nov 9, 2018
Clinical News

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

...Inc. (NYSE:PFE) on Nov. 2, but issued a complete response letter to an NDA from Trevena Inc....
...disease. Lorbrena is an inhibitor of ALK and c-ros proto-oncogene 1 receptor tyrosine kinase (ROS1). Trevena...
...Anesthetic and Analgesic Drug Products Advisory Committee voted 8-7 against recommending approval of Olinvo (see "Trevena...
BioCentury | Nov 2, 2018
Company News

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

...Pfizer Inc. (NYSE:PFE) on Friday, but issued a complete response letter to an NDA from Trevena Inc....
...disease. Lorbrena is an inhibitor of ALK and c-ros proto-oncogene 1 receptor tyrosine kinase (ROS1). Trevena...
...Olinvo (see "Trevena Goes for MOR than Morphine" ). Sandi Wong Biosimilar of pegfilgrastim Dsuvia Olinvo, oliceridine (TRV130) AcelRx Pharmaceuticals Inc. Trevena Inc. Coherus...
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...
...once it is in practice.” Michael Fischer, Brigham and Women’s Hospital Interactions between FDA and Trevena...
...find a partner to take that route. Oliceridine’s PDUFA date is Nov. 2. Trevena’s argument Trevena’s...
BioCentury | Oct 12, 2018
Clinical News

Advisory panel narrowly rejects olicerideine for acute pain

...comparison to morphine, and how they were viewed during Trevena's development program. At the meeting Trevena...
...for which Trevena is seeking approval. The reviewers wrote that FDA "did not agree with Trevena's...
...FDA. Trevena's clinical pipeline also includes migraine compound TRV250 and pain candidate TRV734. In August, Trevena...
Items per page:
1 - 10 of 114