Biogen and Columbia University Medical Center plan to develop a genetic map of ALS using $3.5 million in funds raised by last year’s Ice Bucket Challenge, according to Bloomberg Business. Having a better understanding of the disease’s genetic makeup may help identify how much genes contribute to an ALS diagnosis, a Biogen executive said.
The FDA granted Merck’s PD-1 inhibitor, Keytruda, Priority Review as the drugmaker seeks an indication for the therapy as a first-line treatment for advanced melanoma. The agency set Dec. 19 as the action date. The company is also seeking to get Keytruda approved as a treatment for ipilimumab-refractory advanced melanoma.
Sen. Joe Manchin (D-WV) criticized the FDA’s decision to approve OxyContin for children 11 years old and older, The Hill reported. He called for a Senate investigation into the approval, in part to question why the agency did not convene an advisory committee before making the decision.
Patients with breast cancer who report more side effects from treatment and have poor communication with their doctors are more to likely to skip a dose of a hormone therapy like tamoxifen, according to Reuters. A researcher who is not affiliated with the study said women may not be receiving advice or monitoring about adherence to an endocrine therapy.
Industry spending on clinical research fell 32% in the last five months of 2014, compared to the same period a year, according to Policy & Medicine’s Life Science Compliance Update, which analyzed Open Payments data. The CMS in June released the first full year of Open Payments data, which is mandated by the Physician Payments Sunshine Act.