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4:55 PM, Feb 12, 2018  |  BC Extra | Company News

Third CF candidate from Vertex approved

Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) said FDA approved Symdeko tezacaftor/ivacaftor to treat cystic fibrosis in patients ages 12 and older who have two copies of the delta F508 mutation or who have at least one CF...
4:11 PM, Feb 12, 2018  |  BC Extra | Politics & Policy

Congress likely to reject Trump proposal for flat NIH funding

In his FY19 proposed budget released Monday, President Donald Trump asked Congress to flat-line NIH funding. Just as Congress ignored a Trump administration request to slash the NIH budget last year, it is unlikely to...
4:08 PM, Feb 12, 2018  |  BC Extra | Financial News

DiaCarta closes $45M series B

Molecular diagnostics company DiaCarta Inc. (Hayward, Calif.) said it completed a $45 million series B round. The round’s second close, announced Monday, was led by Fortune Foundation Capital with participation from Good Health Capital. The...
4:08 PM, Feb 12, 2018  |  BC Extra | Financial News

Biotech indexes rise

Biotech indexes rose on Monday as the broader markets climbed for a second straight day. The NASDAQ Biotechnology Index (NBI), NYSE Arca Biotechnology Index (BTK) and BioCentury 100 each gained about 2%, as did the...
3:04 PM, Feb 12, 2018  |  BC Extra | Politics & Policy

Former Celgene CEO Hugin expected to announce run for Senate

Bob Hugin, former executive chairman and CEO of Celgene Corp. (NASDAQ:CELG), is scheduled to speak Tuesday at a Veterans of Foreign Wars location in Delran, N.J., possibly to announce his anticipated run for senator of...
3:00 PM, Feb 12, 2018  |  BC Extra | Politics & Policy

BIO report shows lagging innovation for pain, addiction

The Biotechnology Innovation Organization called attention to lower venture funding and fewer clinical-stage novel compounds within pain and addiction indications in its second report in a series on funding and R&D for highly prevalent chronic...
2:59 PM, Feb 12, 2018  |  BC Extra | Politics & Policy

Trump budgets largest ever FDA spending increase

President Donald Trump's FY19 budget request proposes increasing FDA’s budget by $473 million, including $417 million in new outlays for medical products, over the FY18 budget. This is the largest budget authority appropriation increase in...
2:41 PM, Feb 12, 2018  |  BC Extra | Politics & Policy

Trump budget proposal seeks to cut Medicare, Medicaid drug costs

The Trump administration’s FY19 budget proposal includes numerous provisions that are intended to cut out-of-pocket drug costs for patients, as well as government spending on drugs. Many of the proposals could only be enacted through...
2:24 PM, Feb 12, 2018  |  BC Extra | Company News

FDA, EMA, Japan reviewing Pfizer's lorlatinib for NSCLC

Pfizer Inc. (NYSE:PFE) said FDA accepted and granted Priority Review to an NDA for lorlatinib (PF-06463922) to treat anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) in patients previously treated with one or more...
2:06 PM, Feb 12, 2018  |  BC Extra | Company News

Priority Review for Amicus' migalastat

FDA accepted and granted Priority Review to an NDA from Amicus Therapeutics Inc. (NASDAQ:FOLD) for migalastat (AT1001) to treat Fabry's disease in patients 16 years and older who have amenable mutations. The PDUFA date is...

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