Ethics/Regulatory

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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PhRMA launches new Expanded Access principles

Monday, June 22, 2015

Pharmaceutical Research and Manufacturers of America (PhRMA) has formally introduced new Ex­panded Access principles to assist companies in evaluating whether to voluntarily grant patients access to an investigational treat­ment. Originally introduced to its members last December for review and discussion, PhRMA’s newly implemented Expanded Access principles were recently adopted with commitments from each member.

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