23:07 , May 14, 2019 |  BC Extra  |  Company News

Management tracks: DBV, Beam, Aeon Biopharma

DBV Technologies S.A. (Euronext:DBV; NASDAQ:DBVT) said Deputy CEO and Principal Financial Officer David Schilansky will leave the company in August to pursue other opportunities. The allergy company is searching for a new CFO but will...
19:48 , May 3, 2019 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least 22 profitable biotechs and pharmas are slated to report earnings this week. (A) During trading hours in Europe; premarket on U.S. exchange; (B) Fiscal 4Q; Company Date Pre/post mkt 1Q19...
21:28 , May 2, 2019 |  BC Extra  |  Company News

May 2 Company Quick Takes: Agios, Celgene/Presage, Purdue, Amgen/Syapse

Label expansion in AML for Agios’ Tibsovo  FDA approved an sNDA for Tibsovo ivosidenib from Agios Pharmaceuticals Inc. (NASDAQ:AGIO) as monotherapy for adults with newly diagnosed acute myelogenous leukemia (AML) with a susceptible isocitrate dehydrogenase...
21:52 , May 1, 2019 |  BC Extra  |  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...
20:59 , Apr 15, 2019 |  BC Extra  |  Company News

Supreme Court decision signals likely end to Allergan sovereign immunity gambit

A lower court's ruling that a sovereign entity cannot assert immunity to shield a patent from inter partes review (IPR) will stand, as the U.S. Supreme Court rejected a petition from Allergan and the Saint...
19:57 , Apr 12, 2019 |  BC Extra  |  Company News

Gilead, Novo team up to combine NASH compounds

A day after Gilead presented Phase II data at EASL for its cilofexor plus firsocostat combination to treat non-alcoholic steatohepatitis, the company partnered with Novo Nordisk to test the duo in combination with semaglutide in...
00:03 , Apr 12, 2019 |  BC Week In Review  |  Clinical News

Allergan's modified abicipar pegol decreases intraocular inflammation

Ahead of a BLA submission to FDA this half for AMD therapy abicipar pegol, Allergan and Molecular Partners reported top-line safety data from the Phase II MAPLE trial showing that an optimized formulation of the...
00:06 , Apr 6, 2019 |  BioCentury  |  Finance

Big caps under pressure

Biogen’s fall in the wake of its decision to discontinue late-stage trials of Alzheimer’s therapy aducanumab is yet another reminder that large caps are in dire need of new pipeline products, and could serve as...
13:15 , Apr 1, 2019 |  BC Innovations  |  Emerging Company Profile

Arixa: Breaking resistance with oral beta lactamase inhibitors

Arixa has made an IV antibiotic oral with prodrug chemistry. Arixa Pharmaceuticals Inc. is modifying diazabicyclooctanes, a class of β-lactamase inhibitors that suffer from poor absorption across the GI tract, for use in combination with...
22:50 , Mar 25, 2019 |  BC Extra  |  Company News

Allergan activist investor says plan to split CEO, chair roles lacks urgency

Activist investor Appaloosa said Monday that Allergan's promise to elect an independent chairman would be "nothing more than a meaningless gesture" unless it's enacted in the very near term. Allergan plc (NYSE:AGN) said in a...