Ethics/Regulatory

Immunization programs face growing challenge

Friday, August 21, 2015

People who delay or refuse vaccines for themselves or their children are presenting a growing challenge for countries seeking to close the immunization gap. Globally, one in five children still do not receive routine life-saving immunizations, and an estimated 1.5 million children still die each year of diseases that could be prevented by vaccines that already exist, according to the World Health Organization (WHO).

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China to reform drug approval system

Thursday, August 20, 2015

China has decided to reform its appraisal and approval system for drugs and medical instruments with the aim of improving drug safety and quality and encouraging innovation.

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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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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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