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Top Stories Monday, July 25, 2016 Bristol-Myers Squibb will team up with AbbVie to run an early-stage lung cancer study combining BMS’ marketed checkpoint inhibitors with AbbVie’s experimental antibody drug conjugate Rova-T. Monday, July 25, 2016 Tobira Therapeutics fell by about half in premarket trading on news that its Phase IIb trial to treat nonalcoholic steatohepatitis (NASH) failed to meet the primary endpoint. The South San Francisco, CA-based company aims to trudge ahead, though, by shifting a secondary endpoint that it did meet in Phase IIb into the new primary endpoint for Phase III--with a trial start slated for next year. Monday, July 25, 2016 The first spinout company from Cydan, an orphan disease incubator created by Pfizer Ventures and New Enterprise Associates, is headed full-steam ahead. Known as Vtesse, it’s nabbed an additional $17 million to bump up its Series A financing to total $42 million. Monday, July 25, 2016 Californian upstart Tricida has raised its highest level of cash to date with a $55 million Series C funding round backed by major biotech VC players. Monday, July 25, 2016 The FDA has designated Morphochem’s MCB3837 as a Qualified Infectious Disease Product and simultaneously put the antibiotic on its regulatory fast-track program. The regulatory rulings give Morphochem the opportunity to liaise more frequently with the FDA at a time when it is gearing up for the start of a Phase II trial. Sunday, July 24, 2016 With oral Relistor approval, Valeant just got a new weapon in its battle with AstraZeneca for the opioid-induced constipation throne. Can that weapon reach the billion-dollar sales benchmark quoted by Valeant's GI unit, Salix? Don't count on it. Thursday, July 21, 2016 Biogen has made Medidata Rave its primary clinical trial technology platform. The deal, which marks another transfer of business from Oracle to Medidata, means the Rave provider now has a close working relationship with 18 of the top 25 biopharma companies. | | | GenVec and partner Novartis say the FDA has lifted the clinical hold on the Phase I/II trial of CGF166 in patients with severe-to-profound hearing loss. Statement Bind Therapeutics says two new bidders have joined Pfizer’s stalking horse bid in the auction for the biotech’s assets. Release Merck has been given a breakthrough designation from the FDA and PRIME status from the EMA for its investigational Ebola Zaire vaccine. Statement Ocular Therapeutix has been handed a Complete Response Letter from the FDA for its NDA for Dextenza in postsurgical ocular pain due to manufacturing concerns. Release | |
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Resources Presented by: Biotech Primer This 3-part webinar series is specifically geared toward the non-science professional who needs to better understand industry terminology, science, techniques and issues. Sponsored by: Speid & Associates, Inc. Do you have what it takes? Drug Development training does not have to be boring. Sponsored by: Veeva Systems Gartner research on short- and long-term strategies for IDMP compliance. BioImmersion: In Depth Biotech for the Non-Scientist October 5-7, 2016 | Chicago, IL Drug Development Boot CampTM 2016 November 16-17, 2016 | Boston, MA Characterization of Animal Models for Alzheimer’s disease: Webinar Presented by Charles River July 19, 2016 Master of Science in Bioinformatics at Northeastern University Fall 2016, Spring 2017 Courses BIOSPAIN 2016 September 28-30, 2016 | Bilbao, Basque Country, Spain FierceBiotech Drug Development Forum September 19-21, 2016 | Boston, MA Immunotherapy: Mapping the future July 28, 2016 | Foster City, CA |
