Today's Rundown Spark R&D chief High exits in wake of Roche takeover Genfit's NASH key phase 3 data delayed BioMarin gene therapy won't need an AdComm as it nabs speedy FDA review [Sponsored] Executive Interviews at J.P. Morgan 2020 Struggling Tocagen becomes Nasdaq on-ramp for Forte Bio Effector co-founder leaves to take up CSO post at Turning Point A CRISPR cure for cystic fibrosis? MIT's AI researchers find a new antibiotic in an old drug EuroBiotech Report—GSK's TCR deal, Vifor, PharmaMar filing, NeoTX series C and Novimmune FiercePharmaAsia—Coronavirus's impact on AstraZeneca, global drug supply; vadadustat PRV Chutes & Ladders—Scholefield out as Merck & Co. digital head Featured Story | | | Friday, February 21, 2020 Spark Therapeutics co-founder and R&D head Kathy High has left the gene therapy specialist in the wake of its takeover by Roche. The Basel-based Big Pharma talked up its ability to cope with the loss of the R&D chief, pointing to the 450-person team High helped build to back up its confidence. |
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Top Stories Friday, February 21, 2020 Genfit’s shares were in the red Friday morning after the French biotech announced it was delaying a data readout for its potential blockbuster fatty liver hopeful elafibranor. Friday, February 21, 2020 BioMarin’s hemophilia A drug has been set an Aug. 21 PDUFA date as the California biotech looks to gain a speedy approval for the first gene therapy for the bleeding disease. Thursday, February 13, 2020 FierceBiotech sits down with some of the most informative industry leaders at JPM 2020. Friday, February 21, 2020 Last fall, a late-stage brain cancer flop prompted Tocagen to cut 65% of its workforce to stay afloat. Now, out of options, the one-time cancer specialist will become Forte Biosciences’ route to the public markets. The duo announced Wednesday that they would merge in an all-stock deal. Friday, February 21, 2020 Siegfried Reich has ended his seven-year involvement with Effector Therapeutics. Reich co-founded Effector and served as its senior vice president of research but has moved on to take up the chief scientific officer position at Turning Point Therapeutics. Thursday, February 20, 2020 Scientists at the Hubrecht Institute in the Netherlands used base editing, an approach to CRISPR that doesn’t involve cutting DNA, to correct a gene mutation that causes cystic fibrosis (CF). They believe the study, which they performed in stem cells from CF patients, provides evidence that a disease-causing mutation in the gene CFTR could be corrected without damaging healthy parts of the genome. Friday, February 21, 2020 Researchers at MIT used a machine-learning algorithm to uncover the potent antibiotic properties hiding within a small-molecule drug that had been explored as a potential diabetes treatment. Thursday, February 20, 2020 In this week's EuroBiotech Report, GSK, Immatics strike cell therapy deal, Vifor buys priority review voucher and PharmaMar gets PDUFA date. Friday, February 21, 2020 AstraZeneca braces for COVID-19's impact on its China business as global health regulators monitor for potential disruptions in drug supplies. Akebia Therapeutics will use a priority review voucher on the application for its Otsuka-partnered anemia drug vadadustat. And more. Friday, February 21, 2020 Merck & Co. digital head Scholefield bolts for Marriott; Endo replaces CEO Campanelli; BMS vet Quigley joins Gilead. Resources Sponsored by: Research Solutions / Reprints Desk Inc. 3 ways you may be overspending on scientific literature access, and how to fix them. Sponsored by: H1 Biopharma companies don't want to go to market with a product no one knows about. H1 has homed in on the often time-consuming research and engagement phases that companies must ace for a successful launch, said Ariel Katz, co-founder of H1. Sponsored by: Clinical Ink Download this free white paper to learn how a BYOD ePRO approach is beneficial to your trial. Sponsored by: Catalent This whitepaper discusses the benefits of end-to-end solutions and share case studies on how flexible manufacturing strategies can accommodate the changing landscape of pharmaceutical products and help bring a drug to market. Sponsored by: Accenture Kevin Julian, senior managing director of Accenture’s life sciences practice, recently sat down with FierceBiotech to discuss market trends and Accenture’s new technology platform, INTIENT. Sponsored by: Eagle Productivity Solutions Mediocre adoption rates aren’t due to poorly designed software or lazy users. They’re the result of how skills are trained. Achieve high adoption rates for Veeva, Workday, Microstrategy or any software platform by implementing the right methodology with a focus on behavior change. Sponsored by: Blue Matter Consulting White paper describing how a biopharma company can successfully differentiate an oncology product when the clinical profile alone is not enough to get the job done. Sponsored by: Medidata To conduct a successful trial, do you need to understand the global eConsent Regulatory landscape? Sponsored by: USDM Life Sciences Details on the FDA’s upcoming Computer System Validation guidance Sponsored by: Veeva Learn how data management teams at ICON, Bioforum, and Vertex Pharmaceuticals are creating the spec and casebook in a single step, reducing study build times and effort by over 50%. Sponsored by: Catalent Get expert insights on strategies to implement flexible manufacturing and different technologies that are easily scalable and reproducible. Sponsored by: Catalent Regardless of the assigned FDA expedited approval designation and approach, the key action items should be: the assurance of a detail-oriented plan and the adaption of a “forward-thinking” approach that will assist in any future challenges and opportunities for growth of each project. Sponsored by: Catalent Learn how recent innovations in demand-led supply and direct-to-patient distribution are converging to create a next-generation clinical supply chain that is flexible, lean and most importantly patient-centric. Sponsored by: Altran This whitepaper highlights the challenges of implementing the right digital twin strategy while providing key use cases in the manufacturing domain for which a digital twin is extremely useful and several examples of technology trends that will shape the future. Sponsored by: Catalent Pharma Solutions In this Q&A, four Catalent Biologics experts share how scale-up, regulatory expectations, demand forecasting and process validation all play a role in the success of a biologic when embarking upon the commercial manufacturing journey. Molecular Med TRI-CON: Final Days to Register! March 1-4, 2020 | Moscone North Convention Center | San Francisco, CA BioBasics 101: The Biology of Biotech March 26-27, 2020 | Boston, MA BioBasics 101: The Biology of Biotech April 16-17, 2020 | Philadelphia, PA Drug Development Immersion April 23-24, 2020 | Boston, MA BIO International Convention June 8-11, 2020 | San Diego, CA Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now and begin Pre-Boot Camp Preparation. | Take your new medicine development skills to the next level. | 