Today's Rundown Editor’s Note: FierceBiotech will not publish on Monday in observance of Memorial Day, but we’ll be back in your inbox on Tuesday, May 28. Dynavax axes immuno-oncology pipeline and 82 staff Nektar unveils Inheris Biopharma, its new CNS-focused offshoot Stoke files for $86M IPO to take Dravet drug from preclinical to phase 3 FLX Bio keeps it uppercase in RAPT Therapeutics rebrand Miniature livers reveal behavior of common cancer-causing gene mutation EuroBiotech Report—Novartis-GSK, Affimed U-turn, Amgen-Nuevolution, Roche and VC fund raises cash FiercePharmaAsia—Shingrix's Chinese nod; Chugai's $1B R&D site; Lilly's Verzenio safety woes Chutes & Ladders—Ex-FDA commissioner goes back to biotech investing Featured Story | Friday, May 24, 2019 Dynavax is pulling out of immuno-oncology R&D, laying off 82 staff and parting company with its CEO. The actions will create a slimmed-down commercial-stage company focused on selling hepatitis B vaccine HEPLISAV-B. |
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| Top Stories Thursday, May 23, 2019 Nektar Therapeutics created Inheris Biopharma, a new subsidiary helmed by Merck veteran Jay Galeota that will focus on developing and marketing drugs for central nervous system disorders. Friday, May 24, 2019 Ed Kaye’s Stoke Therapeutics has filed to raise up to $86 million in a Nasdaq IPO. The preclinical-stage biotech wants the cash to take an antisense oligonucleotide treatment for Dravet syndrome through to phase 3. Friday, May 24, 2019 FLX Bio is renaming itself RAPT Therapeutics to reflect its expansion into allergy and inflammatory diseases. Thursday, May 23, 2019 Dutch researchers are using miniature livers, or “organoids,” to study the function of mutated genes in liver cancer. They've uncovered insight into the commonly mutated gene BAP1 that may explain how benign cells in the liver turn malignant. Thursday, May 23, 2019 In this week's EuroBiotech Report, Novartis bests GSK in asthma trial, Affimed scraps T-cell engager program and Amgen inks Nuevolution buyout. Friday, May 24, 2019 GlaxoSmithKline's Shingrix wins nod to tackle China but won't launch until 2020; Roche's Chugai plunks down $1 billion for a new R&D site in Japan; Eli Lilly's oncology rising star Verzenio faces a safety warning in Japan; and more. Friday, May 24, 2019 Ex-FDA commissioner Gottlieb goes back to biotech investing; Seattle Genetics taps pharma veteran as first chief commercial officer; Affimed parts ways with CSO, scraps T-cell engager program; and CSL Behring poaches former manufacturing executive from Biogen. Those moves plus more hirings, firings and retirings throughout the industry. This week's sponsor is ExL Events. | | | Resources Sponsored by: Catalent Download the executive summary to learn key considerations for a successful technology transfer for manufacturing drug products, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Patheon, part of Thermo Fisher Scientific Choosing the Best Sterile Dosage Form for Your Phase I Clinical Supply Needs. Sponsored by: Patheon, part of Thermo Fisher Scientific Designed with speed & flexibility,Quick to Clinic™ for Oral Solid Dose helps deliver products to Phase I Clinic in as little as 14 weeks. Sponsored by: AlphaSense What is agile competitive intelligence, and how can help healthcare researchers stay ahead of the curve? Sponsored by: JPEO-CBRND – Medical Countermeasure Systems MCS is currently seeking broad-based industry/academia collaboration on research and prototype work in technical areas related to developing medical countermeasures for the Joint Warfighter. Sponsored by: Outer Edge Technology Learn how the cloud can support the performance and security requirements for validated, mission-critical applications historically designed and implemented exclusively via on-premises deployment. 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. 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 Medical Sensors Design Conference June 25, 2019 | McEnery Convention Center | San Jose, CA Sensors Expo & Conference June 25-27, 2019 | McEnery Convention Center | San Jose, CA Drug Development Boot Camp® 2019 November 20-21, 2019 | Boston, MA | Register and start preparing Today! |