Today's Rundown Vifor buys priority review voucher for vadadustat filing PharmaMar, Jazz get FDA priority review for lung cancer drug 'Closer to the science': Why Amgen vets Harper and Seidenberg set up their own VC shop [Sponsored] Executive Interviews at J.P. Morgan 2020 Crossover round, check. New team of biopharma execs, check. Now, Imara wants an IPO After $105M funding round, ALX Oncology nabs FDA fast-track tag for cancer hopeful Gene therapy tackles tau tangles in mouse models of dementia Featured Story | | | Tuesday, February 18, 2020 Vifor Pharma has struck a deal to buy a priority review voucher (PRV). The PRV sets Vifor and partner Akebia Therapeutics up to benefit from a fast review at the FDA when they file for approval of chronic kidney disease drug vadadustat. |
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Top Stories Tuesday, February 18, 2020 The FDA has accepted PharmaMar and Jazz Pharmaceuticals’ small cell lung cancer drug for priority review. Getting lurbinectedin on the fast track tees the partners up to learn whether the FDA will approve the drug by mid-August. Tuesday, February 18, 2020 After 17 years at Amgen, head of R&D Sean Harper was ready to get closer to the science. He reunited with his former colleague from Merck and Amgen, Beth Seidenberg, in Los Angeles and set up Westlake Village BioPartners with a $320 million fund. Thursday, February 13, 2020 FierceBiotech sits down with some of the most informative industry leaders at JPM 2020. Tuesday, February 18, 2020 Imara is looking to cap a good 2019 with an initial public offering in 2020. The rare disease biotech wants $86 million on the Nasdaq. Tuesday, February 18, 2020 It’s been a good month for ALX Oncology: After getting off a meaty $105 million series C last week, it’s started this week with two fast-track labels for its experimental drug. Tuesday, February 18, 2020 A University of South Florida team discovered that inactivating a subtype of the protein beta-arrestin-2 in mice reduced levels of the toxic brain protein tau. That restored the mechanism by which the brain disposed of tau before it could form the tangles that are a hallmark of neurodegenerative diseases like Alzheimer's and frontotemporal lobar degeneration, they reported. Resources 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: Research Solutions / Reprints Desk Inc. 3 ways you may be overspending on scientific literature access, and how to fix them. 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. 11th Annual SCOPE Summit: Summit for Clinical Ops Executives February 18-21, 2020 | Orlando, FL 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. | 