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3:35 PM, Aug 14, 2018  |  BC Extra | Company 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...
3:04 PM, Aug 14, 2018  |  BC Extra | Company News

Management tracks: Cheng departing Gilead as CMO

Gilead Sciences Inc. (NASDAQ:GILD) said CMO Andrew Cheng will leave the company, effective Sept. 7, after five months in the role to pursue another opportunity. Gilead did not say who would replace Cheng, who joined...
2:05 PM, Aug 14, 2018  |  BC Extra | Financial News

Loncar's China biopharma fund to list on NASDAQ Wednesday

The Loncar China BioPharma ETF (NASDAQ:CHNA) is scheduled to begin trading on NASDAQ on Wednesday. The ETF bundles the companies of the Loncar China BioPharma Index (LCHINA) under one security that trades in the U.S. Brad...
10:32 AM, Aug 14, 2018  |  BC Extra | Company News

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...
7:02 AM, Aug 14, 2018  |  BC Extra | Company News

Juvenescence, partners form anti-aging biotech

Juvenescence Ltd. (Douglas, Isle of Man), Insilico Medicine Inc. (Baltimore, Md.) and the Buck Institute for Research on Aging (Novato, Calif.) partnered to form anti-aging company Napa Therapeutics Ltd. (Tortola, British Virgin Islands). Napa will use...
4:04 PM, Aug 13, 2018  |  BC Extra | Politics & Policy

Trump signs expanded CFIUS jurisdiction into law

President Donald Trump signed into law Monday the Foreign Investment Risk Review Modernization Act (FIRRMA), which expands the jurisdiction of the Committee on Foreign Investment in the United States (CFIUS) to cover "foundational and emerging...
2:03 PM, Aug 13, 2018  |  BC Extra | Company News

Management tracks: FDA, Allergan

Patrick Frey will depart as chief of staff in FDA’s Office of New Drugs (OND) on Aug. 24 to become director of global regulatory policy and R&D at Amgen Inc. (NASDAQ:AMGN). Khushboo Sharma becomes OND’s...
1:50 PM, Aug 13, 2018  |  BC Extra | Company News

Mustang licenses immunodeficiency gene therapy from St. Jude

Mustang Bio Inc. (NASDAQ:MBIO) gained exclusive, worldwide rights to develop and commercialize an ex vivo lentiviral gene therapy to treat X-linked severe combined immunodeficiency (SCID) from St. Jude Children's Research Hospital. St. Jude will receive an...
1:46 PM, Aug 13, 2018  |  BC Extra | Preclinical News

Polygenic scores increase disease risk prediction

Two studies in Nature Genetics suggest that aggregating SNPs, instead of assessing single SNPs, to generate risk scores from genome-wide association studies (GWAS) could improve predictions for disease risk. The use of individual gene variants identified...
12:53 PM, Aug 13, 2018  |  BC Extra | Company News

Amicus prices Galafold at $315k per year

Amicus Therapeutics Inc. (NASDAQ:FOLD) said Monday that it will price Galafold migalastat at $315,000 per year and vowed to limit annual price increases of the Fabry disease drug to the rate of inflation. On Friday, FDA...

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