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258373 items
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...
2:24 PM, Aug 16, 2018  |  BC Extra | Clinical News

Regeneron, Teva’s anti-NGF mAb meets 16-week endpoints in Phase III for OA pain

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) said fasinumab met the co-primary endpoints at week 16 in a substudy of the larger Phase III FACT LTS & OA trial to...
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...
11:56 AM, Aug 16, 2018  |  BC Innovations | Translation in Brief

Selective hearing

A pair of Cell papers published this month used single-cell RNA sequencing to molecularly define three subtypes of auditory neurons, opening up new therapeutic targets for restoring synaptic connections in hearing loss disorders. Researchers from Decibel...
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...
10:05 AM, Aug 16, 2018  |  BioCentury | Finance

Navigating the Hot Topics landscape

Investors are making aggressive bets on the ability of early stage companies to deliver on the next generation of therapeutics and technologies. But advances in biology and novel technologies come with challenges ranging from unknown...
9:15 AM, Aug 16, 2018  |  BC Innovations | Distillery Therapeutics


INDICATION: Lung cancer Cell culture studies suggest inhibiting IKK or its scaffold protein NEMO in combination with inhibition of MC-1 could help treat STK11-deficient lung cancer. In a human STK11-deficient lung cancer cell line, the MC-1...
9:14 AM, Aug 16, 2018  |  BC Innovations | Distillery Therapeutics


INDICATION: Melanoma Patient sample and mouse studies suggest inhibiting USP7 could help treat metastases of melanoma. In 114 melanoma patients, high primary tumor levels of USP7 correlated with poor survival, and in eight xenograft mouse...
9:13 AM, Aug 16, 2018  |  BC Innovations | Distillery Therapeutics


INDICATION: Pain Mouse and rat studies suggest inhibiting PANX1 or its activator P2RX7 in spinal microglia, or an antibody-drug conjugate (ADC) targeting the microglia, could help treat joint pain. In spinal cord samples from a rat...