How a protein 'Polaroid' led Amgen to finally crack the 'Achilles heel tumor' with Lumakras in 8 years Phase 3 data boost EQRx's plan to undercut checkpoint inhibitors Provention Bio brought back down to earth as FDA panel narrowly backs diabetes prevention drug Karuna investor settles charge of insider trading that netted $120k on nonpublic clinical trial information HCW files for $50M IPO to trial fusion protein in solid tumors Fierce Pharma Asia—Moderna-Samsung COVID vaccine pact; Astellas' 5-year plan; more Novo investment Chutes & Ladders—Fledgling T-cell player Neogene adds Bristol Myers vet to U.S. roster Featured Story | By Annalee Armstrong Two of Amgen’s R&D and clinical development experts gave Fierce Biotech a snapshot into the light-speed development process that brought Lumakras, formerly known as sotorasib, to the cusp of an FDA approval in just over eight years. The agency is considering an application for Lumakras under a breakthrough designation to treat non-small cell lung cancer in patients with a KRAS G12C mutation who have failed on several prior treatments. read more |
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Top Stories By Nick Paul Taylor A phase 3 clinical trial of sugemalimab has met its primary endpoint. CStone Pharmaceuticals, which offloaded rights to the anti-PD-L1 antibody to EQRx and Pfizer last year, enrolled patients with stage 3 non-small cell lung cancer patients in the study. read more By Amirah Al Idrus Provention was flying high on Tuesday when an FDA advisory panel seemed to back the efficacy of its diabetes prevention drug, even after the agency flagged some issues with the data package supporting the therapy's application a month earlier. But the company is not out of the woods yet, with the final vote only narrowly supporting the drug’s approval Thursday afternoon. read more By Annalee Armstrong The SEC settled insider trading charges against one of Karuna Therapeutics’ investors, a doctor and medical investigator who bought more than 1,600 shares after hearing secret details from a positive clinical trial readout. read more By Nick Paul Taylor HCW Biologics has filed to raise up to $50 million in an IPO. The money will set HCW up to take two immunotherapy treatments into the clinic in solid tumors and an autoimmune disorder. read more By Angus Liu Moderna enlisted Samsung Biologics to help with fill-finish of its mRNA COVID-19 vaccine. Astellas targeted $17 billion in fiscal 2025 sales in a new five-year plan. Novo Holdings co-led a $200 million financing round in a Singapore cell and gene therapy tech company. And more read more By Fraiser Kansteiner Neogene snared a longtime BMS leader, courtesy of its quick entry into the next-gen cell therapy space. Tectonic is building out its C-suite roster with a 16-year veteran of the Genomics Institute of the Novartis Research Foundation. And Guardant Health has added oncology drug development bigwig Craig Eagle to its ranks. read more Resources Sponsored by: BBK Worldwide Create a more diverse and inclusive clinical trial enrollment and engagement environment by learning the barriers to participation and the strategies to overcome them. Sponsored by: Thermo Fisher Scientific Autologous cell and gene therapy workflows involve isolating cells from an individual, engineering the cells, expanding and concentrating them, and infusing them back into the patient. Optimized automation of certain steps of the workflow may decrease hands-on time and the cost of the cell manufacturing process. Sponsored By: Veeva Learn how to develop a standards program that has your full team’s buy-in and improves the efficiency and quality of your clinical trials. Sponsored By: Veeva One top 10 pharma outlines three key steps to launching a modular content strategy to generate localized content faster. Sponsored By: Blue Matter This 77-page e-book explores 7 keys to success that any biopharma company needs to keep in mind as it enters Europe. Sponsored by: Datacubed Health The average clinical trial spends $40,000 per patient. Yet despite these high costs, most trials struggle to retain patients. Sponsored By: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. Sponsored By: WCG Trifecta The new standards in study training help sponsors and CROs reduce costs by 60%, cut training time by 50%, and start enrollment 55 days faster – learn more today. Sponsored By: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: August Bioservices How has COVID-19 impacted CRO/CDMO customer (dis)satisfaction and outsourcing decisions for pharma and biotech companies in 2021 and beyond? Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: TAC Roche has inked a $1.8 billion, all-cash deal for GenMark Diagnostics, to acquire its molecular tests designed to screen patient samples for multiple infections simultaneously. Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. Sponsored by: Catalent Autologous cell therapies have seen propelled growth since 2017, with the spotlight on the first FDA approval of a chimeric antigen receptor (CAR) T cell immunotherapy, Kymriah® (tisagenlecleucel), for the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia. Sponsored by: Catalent Learn about drug product process development challenges and risks, the difference between innovator and biosimilar drug product process development, and more during the drug product process development phase. Sponsored by: Catalent Get insights on key considerations for a successful tech transfer process for manufacturing a biologic drug product, including a case study on overcoming challenges in a process transfer for a sterile diluent. Sponsored by: Catalent In a BioPharma Dive industry survey, planning and forecasting were identified as top concerns for trial sponsors. In response to this need, the CSM team at Catalent has developed a methodology for identifying, evaluating, and proactively managing the inherent risks involved in clinical trial supply chain management. Sponsored by: Catalent Learn how to drive excellence within the forecasting process and utilize forecasting throughout the clinical study to better plan clinical supply budgets and project timelines. Explore how to identify potential supply-related issues before they can negatively impact your study. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. HOOKIPA advances new, potent arenaviral immunotherapy class June 7, 2021 | 6:30 pm EDT Vaccines, cell and gene therapy, antibodies, and RNA-based drugs June 10-11, 2021 | 9 a.m. EST / 6 a.m. PST Next Gen: What’s beyond the leading edge of biotech and pharma? 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