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8:01 AM, Aug 17, 2018  |  BC Extra | Company News

Opdivo gets accelerated approval in SCLC population

FDA granted accelerated approval to Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) to treat small cell lung cancer in a third-line setting. BMS said the approval is the first for an immuno-oncology therapy in the...
8:49 PM, Aug 16, 2018  |  BC Week In Review | Company News  |  Other News

CVS to launch ICER-restricted formulary

CVS Health Corp. (NYSE:CVS) plans to offer a new formulary restricted to drugs deemed cost-effective by the Institute for Clinical and Economic Review (ICER). CVS believes the formulary will pressure manufacturers to moderate launch prices...
8:46 PM, Aug 16, 2018  |  BC Week In Review | Company News  |  Sales & Marketing

NICE draft guidance recommends against Biogen's Spinraza for SMA

U.K.’s NICE published draft guidance recommending against the use of Spinraza nusinersen from Biogen Inc. (NASDAQ:BIIB) to treat spinal muscular atrophy. The committee cited significant uncertainties around Spinraza's long-term benefits, as well as the drug's...
8:33 PM, Aug 16, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

Infectious company Aridis raises $26M in NASDAQ IPO

Infectious disease mAb company Aridis Pharmaceuticals Inc. (NASDAQ:ARDS) raised $26 million on Aug. 13 through the sale of 2 million shares at $13 in an IPO on NASDAQ. Cantor Fitzgerald, Maxim Group, Laidlaw, Northland Securities...
8:32 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Motif's antibiotic gets Priority Review

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said FDA accepted and granted Priority Review to an NDA for iclaprim (MTF-100) to treat acute bacterial skin and skin structure infections (ABSSSIs). Its PDUFA date is Feb. 13, 2019. The...
8:32 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA accepts applications for Circassia COPD products Duaklir, Tudorza

Circassia Pharmaceuticals plc (LSE:CIR) said FDA accepted for review an NDA for Duaklir Pressair aclidinium bromide/formoterol fumarate to treat chronic obstructive pulmonary disease (COPD). The company also said the agency accepted an sNDA for Tudorza...
8:32 PM, Aug 16, 2018  |  BC Week In Review | Financial News  |  Completed Offerings

NeoGenomics raises $125M follow-on

NeoGenomics Inc. (NASDAQ:NEO) raised $125 million through the sale of 9.8 million shares at $12.75 in an follow-on underwritten by William Blair, Leerink Partners, Craig-Hallum, Stephens, First Analysis Securities, Janney Montgomery Scott and Benchmark Co....
8:31 PM, Aug 16, 2018  |  BC Week In Review | Company News  |  Other News

Icahn changes course on Express Scripts acquisition

Activist investor Carl Icahn said he no longer opposes the acquisition of Express Scripts Holding Co. (NASDAQ:ESRX) by health insurance company Cigna Corp. (NYSE:CI). The move came after independent proxy advisory firms Glass Lewis &...
8:31 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA gives green light for Regeneron's 12-week Eylea regimen

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA approved an sBLA for an every 12-week dosing schedule of Eylea aflibercept to treat wet age-related macular degeneration (AMD). Eylea's updated label says patients may be treated with every 12-week...
8:30 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Preclinical Results

SOD1 antisense oligonucleotide improves survival in ALS model

Researchers at Biogen Inc. (NASDAQ:BIIB), Ionis Pharmaceuticals Inc. (NASDAQ:IONS) and colleagues reported data from a rat model of superoxide dismutase 1 (SOD1)-mutated amyotrophic lateral sclerosis (ALS) showing that a single bolus dose of intrathecal IONIS-SOD1Rx...

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