Ethics/Regulatory

FDA selects eight new patient groups for input

Monday, July 20, 2015

The FDA released a list of eight new conditions that it plans to assess during the next two years as part of its Patient-Focused Drug Development (PFDD) program. The program seeks to inform regulatory decision-making by soliciting patients’ perspectives on their diseases, treatment options and preferred endpoints for experimental therapies.

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U.S. House passes 21st Century Cures Act

Wednesday, July 15, 2015

The U.S. House of Representatives has approved H.R. 6, the 21st Century Cures Act, by a vote of 344-77 and now goes to the U.S. Senate for consideration. This legislation would reauthorize the National Institutes of Health, focus efforts to increase strategic investments and medical research at the NIH and modernize the approval and regulatory process for new drugs, biologics and medical devices at the FDA.  On May 21, 2015, the bill passed the House Energy and Commerce Committee by a vote of 51–0. 

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FDA sued by advocacy groups seeking hepatitis C trials data

Monday, July 6, 2015

Seeking to force faster disclosure of clinical trial data that helped Gilead Sciences win approval for two blockbuster hepatitis C drugs, two public health advocacy organizations filed a lawsuit against the FDA last month—the latest legal action where researchers and patient advocates have scuffled with drug makers and regulators over access to such information.

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Report: Venture financing in biotech follows male CEOs and boards

Monday, June 29, 2015

Gender still plays a role in biotech, with venture financing closely following male CEOs and all male boards, found Liftstream, a London-based company providing executive recruitment services to the biotechnology sector. Liftstream has published a new gender diversity report, Investing in Biotechnology Management, a study of venture financing and hiring trends in European and U.S. biotechnology companies and the gender representation on the boards and at the executive level. The research analyses 110 investment deals in private biotechnology companies as well as 308 biotech executive appointments.

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ASBM responds to Australia’s breaks with other regulators on biosimilar substitution

Wednesday, June 24, 2015

The Alliance for Safe Biologic Medicines (ASBM) has condemned recent announcements by Australian Health Minister Sussan Ley and the Pharmaceutical Benefits Advisory Committee (PBAC) that Australia would break with widely-held international standards by becoming the first and only nation to allow pharmacy-level substitution of biologic medicines without physician involvement.

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