| This week's sponsor is Ajinomoto Bio-Pharma Services. | | | |
Today's Rundown Gottlieb criticizes sponsors’ ‘continued reluctance’ to rethink clinical trials NASH-focused Genfit guns for $132M Nasdaq IPO FDA delays Karyopharm PDUFA to review extra information [Sponsored] Incorporating The Patient Voice To Improve Ulcerative Colitis Recruitment ExcepGen emerges from Y Combinator, taking aim at better proteins for drug discovery EuroBiotech Report—BioNTech IPO; AstraZeneca-Seres; Snipr's $50M round; CARB-X and EMA FiercePharmaAsia—Gilead loses Riva to Glenmark; Biocon biosim plant; Akili-Shionogi pact Chutes & Ladders—Novartis' Sandoz chief exits, fueling spinoff and sale rumors Featured Story | | | Friday, March 15, 2019 Outgoing FDA Commissioner Scott Gottlieb, M.D., has criticized the “continued reluctance” of sponsors and CROs to adopt innovative approaches to clinical trials. Gottlieb challenged industry and academia to invest in new approaches and realign incentives to make clinical research more agile and effective. |
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Top Stories Thursday, March 14, 2019 Genfit will offer 5 million shares at $26.33 apiece in the hopes of raising up to $132 million in its U.S. debut. With the proceeds, Genfit hopes to complete the phase 3 trial for its lead asset elafibranor and build out its commercial organization in preparation for a potential launch. Friday, March 15, 2019 The FDA has pushed back the PDUFA date for Karyopharm Therapeutics’ oncology drug selinexor by three months. Officials took the action after Karyopharm complied with the FDA’s request for more information. Monday, March 11, 2019 Strengthen Your Protocol With Patient Insights. See how Covance helps sponsors reduce patient burden to increase participation and improve patient retention. Friday, March 15, 2019 ExcepGen is officially launching out of Y Combinator with technology that uses an engineered human cell line to produce full-length human proteins for use in drug discovery. Its founders believe the approach could speed up discovery and even come up with protein targets previously thought to be undruggable. Thursday, March 14, 2019 In this week's EuroBiotech Report, buzz about $800 million BioNTech IPO grows, AstraZeneca teams up with Seres and CRISPR startup raises $50 million. Friday, March 15, 2019 Gilead oncology EVP Alessandro Riva, M.D., will take the helm at Glenmark's U.S.-based innovation spinoff; the FDA dinged a plant where Biocon makes Mylan-partnered biosimilars; Shionogi is licensing rights to Akili's video game-based therapeutics; and more. Friday, March 15, 2019 Novartis' Sandoz chief Richard Francis exits, fueling spinoff and sale rumors; NCI Director Ned Sharpless to be interim FDA commissioner; C4 poaches new CMO; and Karuna hires another ex-Lilly scientist. Those moves plus more hirings, firings and retirings throughout the industry. Resources Sponsored by: Outer Edge Technology Software end of life puts you at risk for data breaches, business disruption and liability. Sponsored by: Patheon, part of Thermo Fisher Scientific The Right Partner Can Improve Flexibility and Mitigate Risks from Forecast Inaccuracy in Biomanufacturing. Sponsored by: Patheon, part of Thermo Fisher Scientific Download this whitepaper to learn more. Sponsored by: ON24 Which HCP Touchpoints and channels are yielding the best results in today’s digital world? Sponsored by: Blue Matter White paper outlining the key types of cell-based immunotherapies in oncology, as well as the development and commercial outlook for each. Sponsored by: AlphaSense It’s never been more challenging to stay on top of trends and innovation shaping the future of healthcare. Discover how AI can help competitive intelligence teams achieve more proactive strategies. Sponsored by: Biotech Primer The Biopharma industry is moving at lightning speed and it can be a challenge to keep pace. Here at Biotech Primer we spend hours each week researching, writing, and editing original content for the Biotech Primer WEEKLY with one goal in mind: to help everyone better understand the latest science and technology driving today’s healthcare industry. BioBasics: Biotech For The Non-Scientist March 28-29, 2019 | Boston, MA Drug Development Immersion April 3-4, 2019 | Philadelphia, PA BioBasics: Biotech For The Non-Scientist May 8-9, 2019 | New York, NY Drug Development Immersion May 16-17, 2019 | Boston, MA 2019 BIO International Convention June 3-6, 2019 | Philadelphia, PA FierceBiotech Executive Breakfast at BIO 2019 – Getting Real: The Changing Tide on Real-World Evidence in Drug Development June 5, 2019 | Philadelphia, PA Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! Calling Europe – Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! | 