18:27 , Mar 30, 2018 |  BC Week In Review  |  Company News

ICER issues final evidence report on CAR T therapies with policy recommendations

After the Institute for Clinical and Economic Review's California Technology Assessment Forum held a public meeting to discuss the comparative effectiveness and value of CAR T therapies, the institute released a final evidence report with...
00:43 , Mar 3, 2018 |  BioCentury  |  Finance

Rocky road

While a trio of buysiders who spoke with BioCentury believe sentiment toward Celgene Corp. will remain poor in the near term in the wake of a regulatory delay for ozanimod, they believe commercial success from...
00:06 , Mar 3, 2018 |  BC Extra  |  Politics & Policy

Senator questions pharmas on use of tax savings

Sen. Tina Smith (D-Minn.) sent letters to the CEOs of five large U.S. pharmas on Thursday questioning how they have been using their corporate tax savings since the passage of the Tax Cuts and Jobs...
20:46 , Feb 16, 2018 |  BC Week In Review  |  Clinical News

Priority Review for Agios' ivosidenib

Agios Pharmaceuticals Inc. (NASDAQ:AGIO) said FDA accepted and granted Priority Review to an NDA for ivosidenib (AG-120) to treat relapsed or refractory acute myelogenous leukemia (AML) in patients with an isocitrate dehydrogenase 1 (IDH1) mutation....
19:38 , Feb 16, 2018 |  BC Week In Review  |  Clinical News

FDA approves Banyan's brain trauma blood test

FDA approved the Banyan Brain Trauma Indicator (BTI) from Banyan Biomarkers Inc. (Alachua, Fla.) as an in vitro diagnostic blood test to aid in the evaluation of adults with suspected mild traumatic brain injury (TBI)....
19:45 , Feb 15, 2018 |  BC Extra  |  Company News

Priority Review for Agios' ivosidenib

Agios Pharmaceuticals Inc. (NASDAQ:AGIO) said FDA accepted and granted Priority Review to an NDA for ivosidenib (AG-120) to treat relapsed or refractory acute myelogenous leukemia (AML) in patients with an isocitrate dehydrogenase 1 (IDH1) mutation....
22:50 , Jan 19, 2018 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least seven profitable biotechs and pharmas are slated to report earnings this week. (A) Premarket on U.S. exchanges, during trading hours in Europe; (B) Fiscal 3Q CompanyDatePre/post mkt4Q17 EPS est4Q16 EPSExpected chgJohnson &...
23:36 , Jan 17, 2018 |  BC Extra  |  Company News

Management tracks: NanoString, Orchard

Molecular diagnostics company NanoString Technologies Inc. (NASDAQ:NSTG) hired Thomas Bailey as CFO. He was CFO of AgaMatrix Holdings LLC (Salem, N.H.). Gene therapy company Orchard Therapeutics Ltd. (London, U.K.) hired Frank Thomas as CFO and CBO....
20:41 , Jan 5, 2018 |  BC Week In Review  |  Company News

ICER issues affordability and access alert for tardive dyskinesia drugs

The Institute for Clinical and Economic Review issued an affordability and access alert for tardive dyskinesia drugs Ingrezza valbenazine (MT-5199, NBI-98854) and Austedo deutetrabenazine (SD-809), saying the drugs far exceed ICER’s budget impact threshold at...
00:20 , Dec 22, 2017 |  BC Innovations  |  Product R&D

Dengvaxia’s warning

The fallout of Sanofi’s dengue vaccine debacle has researchers scrambling to rationalize whether competitor products will fall afoul of the same effects, and whether other, related fields should change course. The early upshot is that...