Weaker IP protection, more Medicare cuts could stifle drug access Reducing intellectual property protection for biologic drugs and further cutting Medicare Part B reimbursements would suppress access to needed drugs and weaken community caregivers, writes Peter Pitts, president of the Center for Medicine in the Public Interest and a former associate commissioner at the FDA. Part B's reimbursement formula is helping to curb long-term health care costs and guarantees access to necessary treatments, Pitts writes. Forbes (8/2)
Isis discontinues development of ISIS-CRPRx for rheumatoid arthritis Isis Pharmaceuticals is halting development of its investigational drug ISIS-CRPRx as a treatment for rheumatoid arthritis based on the findings of a Phase II study. The drug failed to significantly outperform a placebo in the alleviation of symptoms. The firm will continue to develop the drug for other diseases, including atrial fibrillation. Reuters (8/5) | Medicines Co. finalizes buyout of ProFibrix The Medicines Co. has finalized its acquisition of ProFibrix following the successful late-stage trial of the latter's Fibrocaps for the control of surgical bleeding. Fibrocaps is a dry, topical formulation of the coagulation proteins fibrinogen and thrombin. Medicines paid ProFibrix $90 million upon closing on top of the $10 million upfront fee paid in June. Additional payments of up to $140 million are contingent on certain milestones. Bloomberg Businessweek/The Associated Press (8/5) | | Industrial & Environmental | Energy Department commits $22M for price-competitive biofuels The Department of Energy is committing $22 million in new investments to promote development of biofuels that can compete pricewise with fossil fuels. "By partnering with industry and universities, we can help make clean, renewable biofuels cost-competitive with gasoline, give drivers more options at the pump and cut harmful carbon pollution," said Energy Secretary Ernest Moniz. United Press International (8/2) | BIO Survey on FDA-Sponsor Communication During Drug Development BIO is conducting a survey to capture information about your interactions with FDA during the various stages of drug development prior to submitting an NDA/BLA. This survey is designed to assist in the implementation of the PDUFA V program on Enhancing Communication during drug development. Your feedback will be used to better understand and measure FDA's existing communication practices and to help identify best practices for communicating with sponsors, which will further inform BIO's future advocacy. Take the survey. We expect it to take 20-30 minutes. If you have any questions, please contact Charles Crain. |  | The best way out is always through." -- Robert Frost, American poet | | | The news summaries appearing in BIO SmartBrief are based on original information from news organizations and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The information is not compiled or summarized by BIO. Questions and comments should be directed to SmartBrief at bio@smartbrief.com. | Please contact one of our specialists for advertising opportunities, editorial inquiries, job placements, or any other questions.
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