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11:18 AM, Feb 23, 2018  |  BC Extra | Politics & Policy

FDA planning pilot program for innovative trial designs

FDA intends to launch by year end a pilot program for complex innovative designs of clinical trials, according to a notice in the Federal Register. The agency will seek input on the program at a...
11:01 AM, Feb 23, 2018  |  BC Extra | Clinical News

Bellicum planning changes to end clinical hold

Bellicum Pharmaceuticals Inc. (NASDAQ:BLCM) said FDA has outlined criteria required to lift the agency's clinical hold on U.S. trials of adjunct T cell therapy BPX-501. The treatment, which consists of genetically modified donor cells and...
4:56 PM, Feb 22, 2018  |  BC Extra | Politics & Policy

SubHealth to review bill on dispensing of injectable opioids

The health subcommittee of the House Energy & Commerce Committee will hold a hearing Feb. 28 to examine a series of bills pertaining to the Controlled Substance Act, including a bill that would allow pharmacies...
4:13 PM, Feb 22, 2018  |  BC Extra | Preclinical News

Patient-derived GI cancer organoids predict treatment response

Researchers at The Institute of Cancer Research have developed a living biobank of metastatic gastrointestinal cancer patient-derived organoids (PDOs), and showed PDOs could help predict patient responses to cancer treatment. In a paper published in Science,...
3:16 PM, Feb 22, 2018  |  BC Extra | Politics & Policy

NZ government to continue funding for rare diseases

The New Zealand Parliament Associate Minister of Health Julie Anne Genter said that PHARMAC, the government agency which determines public funding for pharmaceuticals, will continue trial-specific funds for rare diseases this year and the NZ$5...
3:12 PM, Feb 22, 2018  |  BC Extra | Politics & Policy

Prime says drug spending down in 2017

Prime Therapeutics LLC (Eagan, Minn.) said overall member spending in 2017 dropped 0.2% for commercial drugs, 0.8% for Medicare Part D drugs and 5.4% for Medicaid drugs compared to 2016. The PBM said autoimmune drugs were...
3:09 PM, Feb 22, 2018  |  BC Extra | Politics & Policy

FDA regulations down

FDA had a significant slowdown in regulatory actions last year and the fewest guidances in four years, said a new report by PricewaterhouseCoopers's Health Research Institute (HRI). According to the report, FDA Commissioner Scott Gottlieb has...
3:07 PM, Feb 22, 2018  |  BC Extra | Company News

Sangamo, Gilead in cell therapy gene editing deal

Sangamo Therapeutics Inc. (NASDAQ:SGMO) gained $3.20 (14%) to $25.40 on Thursday after partnering with the Kite Pharma Inc. subsidiary of Gilead Sciences Inc. (NASDAQ:GILD) to use Sangamo's zinc finger nuclease (ZFN) and adeno-associated virus (AAV)...
2:56 PM, Feb 22, 2018  |  BC Extra | Clinical News

Apellis reports 18-month data for GA candidate

Apellis Pharmaceuticals Inc. (NASDAQ:APLS) reported 18-month data from the Phase II FILLY trial to treat geographic atrophy showing that APL-2 for 12 months maintained significant reductions in lesion growth at six months after stopping treatment....
1:59 PM, Feb 22, 2018  |  BC Extra | Company News

Court sides with FDA in Sensipar exclusivity case

A federal court sided with FDA in a lawsuit in which Amgen Inc. (NASDAQ:AMGN) alleged that the agency had applied standards inconsistently when it denied pediatric exclusivity to Amgen's Sensipar cinacalcet, despite granting the same...

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