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5944 items
1:34 PM, Aug 17, 2018  |  BC Extra | Politics & Policy

China unveils cancer drugs for medical insurance access negotiation

China's State Medical Insurance Administration announced 18 cancer drugs that will be included in 2018 medical insurance access negotiations. Companies with drugs on the list will now enter into negotiations to include the drugs on...
4:24 PM, Aug 16, 2018  |  BC Extra | Politics & Policy

Innovative drugs reformer Bi out amid China vaccines scandal

Thursday’s resignation of Jingquan Bi, party secretary of the State Administration of Market Supervision, means that China has lost a champion of innovative biopharma products; however, it remains to be seen whether his departure will...
2:59 PM, Aug 16, 2018  |  BC Extra | Politics & Policy

Trump calls for federal lawsuit against opioid companies

Upon President Donald Trump's request, Attorney General Jeff Sessions agreed during a cabinet meeting Thursday to sue U.S. drug manufacturers for aiding the opioid crisis. While several states have already filed suit against companies such...
2:28 PM, Aug 16, 2018  |  BC Extra | Politics & Policy

NIH seeks to trim gene therapy review, turn oversight to newer tech

NIH wants to scrap Recombinant DNA Advisory Committee (RAC) review for gene therapy protocols in a move that will reduce redundant oversight while allowing RAC to advise on newer innovations. NIH established RAC in 1974 to...
2:28 PM, Aug 16, 2018  |  BC Extra | Politics & Policy

U.K. offers no solace on future access to EU research funding

The U.K. government reiterated a promise that Brexit will not affect funding of current U.K. projects under Horizon 2020, the European Commission's research funding program, but stopped short of clarifying U.K. researchers' access to Horizon...
1:07 PM, Aug 16, 2018  |  BC Extra | Politics & Policy

FDA, NIAID to host workshop for microbiome products

FDA and NIH’s National Institute of Allergy and Infectious Diseases will hold a workshop on Sept. 17 to discuss the clinical, manufacturing and regulatory considerations of live microbiome-based products when used to prevent or treat...
11:38 AM, Aug 16, 2018  |  BC Extra | Politics & Policy

Bach proposes CAR T payment options for CMS

In a perspectives piece in the New England Journal of Medicine, Peter Bach recommended several different payment options that CMS could employ under its National Coverage Determination (NCD) for CAR Ts, including the use of...
4:04 PM, Aug 13, 2018  |  BC Extra | Politics & Policy

Trump signs expanded CFIUS jurisdiction into law

President Donald Trump signed into law Monday the Foreign Investment Risk Review Modernization Act (FIRRMA), which expands the jurisdiction of the Committee on Foreign Investment in the United States (CFIUS) to cover "foundational and emerging...
6:17 AM, Aug 10, 2018  |  BC Extra | Politics & Policy

FDA rolls out guidance for seamless cancer trials

FDA released draft guidance Friday outlining how companies can use seamless trial designs to consolidate the traditional three-phase approach into one first-in-human study to expedite development of cancer drugs and biologics. Seamless trials use a single...
3:00 PM, Aug 09, 2018  |  BC Extra | Politics & Policy

China releases list of overseas drugs eligible for Priority Review

China’s Drug Evaluation Center posted a list of 48 drugs already approved in the U.S., EU or Japan that could be eligible for Priority Review in China. Last December, China's State Drug Administration released guidance to...