Ethics/Regulatory

Mylan confirms Zytiga-related patent challenge

Wednesday, August 19, 2015

Mylan has been sued by BTG International, Janssen Biotech, Janssen Oncology and Janssen R&D in connection with the filing of an Abbreviated New Drug Application (ANDA) with the FDA for Abiraterone Acetate Tablets, 250mg. This product is the generic version of Zytiga, which is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer.

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AB Science warned about putting study volunteers in danger

Monday, July 27, 2015

The FDA’s Office of Scientific Investigations has issued a warning letter to Paris-based AB Science, a pharmaceutical company that targets cancer and other diseases with high unmet medical need, for compromising the safety of study participants by failing to properly monitor its clinical trials and ensure investigators follow protocol requirements.

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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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