BioCentury | Jul 24, 2020
Regulation

Data Bytes: CHMP’s July recommendations

Among the 11 new medicines recommended for approval by EMA’s CHMP is the first antibody-drug conjugate, and most advanced BCMA-targeted agent, for multiple myeloma patients: GSK’s Blenrep belantamab mafodotin. FDA’s Oncologic Drugs Advisory Committee unanimously...
BioCentury | Feb 21, 2020
Product Development

Feb. 20 Product Development Quick Takes: Priority Review puts BioMarin on track to score first hemophilia gene therapy approval in U.S.; plus Gilead-CDC, Genfit

BioMarin's hemophilia gene therapy gets Priority Review  BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) could become the first company to have a hemophilia gene therapy approved in the U.S. FDA accepted and granted Priority Review to a BLA...
BC Extra | Jan 17, 2020
Company News

Jan. 17 Company Quick Takes: FDA expands label of Novo’s Ozempic; plus Intercept, Durect, Coherus-Innovent, CoImmune-Formula and Momenta

Label expansion for Novo’s Ozempic  FDA approved Ozempic subcutaneous semaglutide from Novo Nordisk A/S (CSE:NOVO B; NYSE:NOVO) to reduce the risk of major adverse cardiovascular events in adults with Type II diabetes and heart disease....
BC Extra | Jan 14, 2020
Company News

Amid need for new pain options, FDA panel rebuffs Nektar’s ‘safer’ opioid

Regulators and physicians are urgently seeking novel pain therapeutics to combat the opioid crisis without compromising treatment availability for chronic pain patients, but according to an FDA panel, Nektar’s oxycodegol shouldn’t make the cut based...
BC Extra | Jan 2, 2020
Clinical News

Durect looks ahead to liver indications after Phase IIa miss in psoriasis

Although the failure of topical DUR-928 in a Phase IIa psoriasis trial vaporized more than a quarter of Durect’s market cap on Thursday, the company is pressing on with clinical studies of injectable and oral...
BC Extra | Oct 29, 2019
Company News

Oct. 28 Company Quick Takes: MOR106 dropped in atopic dermatitis; plus Blueprint, Merus, Gilead-Glympse, Heron and GSK

Galapagos, MorphoSys, Novartis discontinue atopic dermatitis program  With an interim analysis indicating futility of the Phase II IGUANA trial, MorphoSys AG (Xetra:MOR; NASDAQ:MOR), Galapagos N.V. (Euronext:GLPG; NASDAQ:GLPG) and Novartis AG (NYSE:NVS; SIX:NOVN) terminated development of...
BC Extra | Oct 3, 2019
Company News

Oct. 2 Company Quick Takes: Merck, Immunovant, PureTech-Ariya, Viscient-Organovo and Durect

China approves Keytruda monotherapy for 1L NSCLC  China's National Medical Products Administration approved PD-1 inhibitor Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) as a monotherapy for first-line treatment of locally advanced or metastatic non-small...
BC Extra | May 1, 2019
Company News

May 1 Company Quick Takes: Heron, Nabriva, Allergan, GSK, Merck, Alnylam

Complete response letter for Heron’s non-opioid pain therapy  Heron Therapeutics Inc. (NASDAQ:HRTX) was off $3.93 (18%) to $17.75 on Wednesday after FDA issued a complete response letter for an NDA for HTX-011 to manage postoperative...
BC Week In Review | Jan 4, 2019
Clinical News

Heron's non-opioid HTX-011 gets Priority Review

FDA accepted and granted Priority Review to an NDA for HTX-011 from Heron Therapeutics Inc. (NASDAQ:HRTX) for postoperative pain management. The PDUFA date is April 30. Heron said FDA indicated that it has no plans...
BC Extra | Dec 31, 2018
Company News

Heron's non-opioid HTX-011 gets Priority Review

FDA accepted and granted Priority Review to an NDA for HTX-011 from Heron Therapeutics Inc. (NASDAQ:HRTX) for postoperative pain management. The PDUFA date is April 30. Heron said FDA indicated that it has no plans...
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