BC Extra | Jan 24, 2020
Company News

ICER finds first wave of new sickle cell drugs improves outcomes, but not cost-effective

A draft cost-effectiveness report from the Institute for Clinical and Economic Review found that the three marketed sickle cell drugs would have to take steep price cuts to hit the $150,000 per quality-adjusted life year...
BioCentury | Jan 8, 2020
Politics, Policy & Law

Over 200 biopharma leaders endorse commitment to patients and the public

Dismayed by their industry’s abysmal reputation, leaders of small and medium-sized biotechs are taking rebuilding public trust into their own hands. Led by six CEOs, executives representing over 150 companies have signed an open letter...
BC Extra | Nov 26, 2019
Company News

Nov. 25 Company Quick Takes: FDA approves GBT's sickle cell therapy; plus ChemoCentryx, Astellas, La Jolla, Sorrento, Aquestive

GBT's sickle cell therapy snags accelerated approval  FDA granted accelerated approval to Oxbryta voxelotor from Global Blood Therapeutics Inc. (NASDAQ:GBT) to treat sickle cell disease three months ahead of its Feb. 26 PDUFA date, marking...
BC Extra | Nov 16, 2019
Company News

Approval of first targeted sickle cell therapy heralds arrival of new agents

Scoring approval about two months ahead of its PDUFA date, Adakveo crizanlizumab-tmca from Novartis AG (NYSE:NVS; SIX:NOVN) is the first targeted sickle cell therapy approved by FDA, designed to cut the disease’s pathology at the...
BioCentury | Nov 9, 2019
Product Development

Sickle cell disease poised for fresh infusion of hemoglobin-based endpoints

As new therapies designed to cut off sickle cell disease pathology at the root advance through the clinic, the field is moving beyond endpoints centered on pain crises to readouts based on hemoglobin. A single,...
BC Extra | Sep 5, 2019
Company News

Sept. 5 Company Quick Takes: Zafgen exploring alternatives; plus BridgeBio, Global Blood, Akouos, Mallinckrodt, uBiome

Zafgen evaluating strategic options  Metabolic company Zafgen Inc. (NASDAQ:ZFGN) has retained advisory firm MTS Health Partners to explore strategic alternatives after receiving new preclinical data that the company believes will be insufficient for FDA to...
BC Extra | Jun 27, 2019
Financial News

June 26 Financial Quick Takes: Adaptive prices upsized IPO; plus BridgeBio, Medicines Co., Global Blood, Odonate

Adaptive raises $300M in IPO  Adaptive Biotechnologies Inc. (NASDAQ:ADPT) raised $300 million through the sale of 15 million shares at $20 in an IPO on NASDAQ. The deal price values the computation immunology and diagnostics...
BC Extra | Jun 14, 2019
Clinical News

June 14 Clinical Quick Takes: Chi-Med, BeiGene, UCB, Global Blood and more

Chi-Med’s surufatinib meets in Phase III for extra-pancreatic neuroendocrine tumors  Hutchison China MediTech Ltd. (LSE:HCM; NASDAQ:HCM) said it is planning a pre-NDA meeting with China’s National Medical Products Administration (NMPA) after surufatinib (formerly sulfatinib) met...
BC Extra | Mar 18, 2019
Financial News

OrbiMed, Arix lead Imara's $63M B round

Imara will use its $63 million series B round to prepare lead compound IMR-687 for a Phase III program in adults with sickle cell disease, and to position the oral phosphodiesterase-9 (PDE-9) inhibitor for pediatric...
BC Week In Review | Dec 7, 2018
Clinical News

Global Blood's sickle cell therapy heading for NDA

Global Blood Therapeutics Inc. (NASDAQ:GBT) said FDA agreed with a proposed regulatory path by which the company could obtain accelerated approval of voxelotor (formerly GBT-440) to treat sickle cell disease. Global Blood hopes to meet...
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