BioCentury | Aug 13, 2020
Regulation

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

...NS Pharma is a Nippon Shinyaku Co. Ltd. (Tokyo:4516) subsidiary.Trevena’s opioid agonist approvedFDA approved Olinvyk oliceridine...
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

...carcinoma. Trevena’s pain therapy back under review FDA is reviewing a resubmitted NDA for Olinvo oliceridine...
...G protein biased MOR ligand has an Aug. 7 PDUFA date (see “FDA Rebuffs Trevena’s Olinvo”...
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

...Trevena Inc. (NASDAQ:TRVN) said it has completed enrollment in a QT prolongation study of Olinvo oliceridine...
...acute pain in adults in 1Q20 (see “FDA Approves AcelRx, Coherus, Pfizer Products, Rebuffs Trevena’s Olinvo”...
...505(b)(2) regulatory pathway and expects to begin dosing healthy volunteers within a month. BioCentury Staff Olinvo, oliceridine (TRV130) Praluent...
BioCentury | Nov 9, 2018
Clinical News

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

...after FDA said the submitted safety database is not of adequate size to approve Olinvo oliceridine...
...whom IV opioids are warranted. The agency also requested additional clinical data on QT prolongation. Olinvo...
...Udenyca pegfilgrastim-cbqv, Lorbrena lorlatinib, Olinvo oliceridine (TRV130) Business: Neurology, hematology, cancer Sandi Wong Biosimilar of pegfilgrastim Dsuvia Olinvo, oliceridine (TRV130) AcelRx...
BioCentury | Nov 2, 2018
Company News

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

...after FDA said the submitted safety database is not of adequate size to approve Olinvo oliceridine...
...whom IV opioids are warranted. The agency also requested additional clinical data on QT prolongation. Olinvo...
...approval of Olinvo (see "Trevena Goes for MOR than Morphine" ). Sandi Wong Biosimilar of pegfilgrastim Dsuvia Olinvo, oliceridine (TRV130) AcelRx...
BioCentury | Oct 13, 2018
Product Development

Trevena goes for MOR than morphine

...Oliceridine’s PDUFA date is Nov. 2. Trevena’s argument Trevena’s argument for approval rests primarily on oliceridine...
...oliceridine triggers slightly different downstream signaling (see “Sidebar: Conscious Bias”). Sidebar: Conscious bias Trevena Inc.’s oliceridine...
...Philadelphia, Pa. U.S. Food and Drug Administration (FDA), Silver Spring, Md. Emily Cukier, Senior Writer Olinvo, oliceridine (TRV130) Trevena...
BioCentury | 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...
...clinically relevant because that Olinvo dose provided less analgesia than morphine. FDA's document also said Olinvo...
...of OPRM1. Trevena Inc. (NASDAQ:TRVN), Chesterbrook, Pa. Product: Olinvo oliceridine (TRV130) Business: Neurology BC Staff Olinvo, oliceridine (TRV130) Trevena...
BioCentury | 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...
...pain in adults for whom IV opioids are warranted. Panelists who voted for approval thought oliceridine...
...a G protein-biased ligand of OPRM1. Trading in Trevena was halted on Thursday. Emily Cukier Olinvo, oliceridine (TRV130) Trevena...
BioCentury | Oct 9, 2018
Company News

FDA reviewers doubt benefits of Trevena's analgesic over morphine

...64%) to $1.07 on Tuesday after FDA reviewers expressed doubts that the company’s Olinvo oliceridine (TRV130...
...clinically relevant because that Olinvo dose provided less analgesia than morphine. FDA's document also said Olinvo...
...therapy's PDUFA date is Nov. 2; it has breakthrough therapy designation from FDA. Paul Bonanos Olinvo, oliceridine (TRV130) Trevena...
BioCentury | Oct 6, 2018
Finance

Seeking validation

.../ Mylan N.V. (NASDAQ:MYL) Revefenacin (TD-4208) COPD PDUFA date 11/13/18 Trevena Inc. (NASDAQ:TRVN) Olinvo oliceridine (TRV130...
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