| | Webinar: Key Ingredients for Your Security Framework Monday, June 7 | 2pm ET / 11am PT Large or small, cyberattacks are making headlines and elevating executive attention toward cyber resiliency. During this session, we will explore security considerations for developing cyber resilience covering security fundamentals and readiness planning to protect your IT and OT environments. Register now. |
WELCOME TO FIERCE LIFE SCIENCES WEEKLY DIGEST A week ago today, Amgen’s closely watched KRAS med Lumakras scored its FDA approval. Just before the approval came down, Fierce Biotech profiled Amgen’s 8-year journey with the drug, which started with an X-ray of the molecular structure that makes up the KRAS protein. Aside from those headlines, Abbott this week slashed its sales forecast as COVID-19 testing demand dries up. Novo Nordisk is hoping to gain FDA approval for its high-dose Ozempic after a prior rejection. Those stories, plus our top reads of the week, follow below. | |
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Featured Story | By Noah Higgins-Dunn What was once considered the "Achilles heel" of lung cancer tumors, as Amgen puts it, now has an FDA-approved treatment in the company's KRAS inhibitor, Lumakras. read more |
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Top Stories Of The Week 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 By Conor Hale The peak for COVID-19 testing may have thoroughly passed—judging by Abbott's new sales projections, at least. The testing giant now projects steeper-than-expected declines in diagnostic testing as vaccination rates climb, and it's not only slashed its sales forecast by as much as $2 billion, but also cut its spending plans for the rest of the year. read more By Fraiser Kansteiner Novo Nordisk is back for round two with a new Ozempic dosing regimen. The diabetes specialist resubmitted to the FDA on Friday after a March snub, renewing its bid to compete with Eli Lilly's already approved higher dose. read more By Kyle LaHucik The FDA told NRx Pharmaceuticals to try again in September when they attempted to obtain authorization for a COVID-19 therapy. Now, the biotech thinks they have the data they need to finally get the nod. Radnor, Pennsylvania-based NRx filed for emergency use authorization yesterday with the FDA for aviptadil-acetate, or Zyesami, to be used in COVID-19 patients with respiratory failure. read more By Beth Snyder Bulik As the American Society of Clinical Oncology conference preps to open this week, AstraZeneca asked cancer experts what they think about mentioning the C-word—in this case, cure—in talking about cancer treatment. The exercise shone a light on drug development advances—and what happens as some cancer cures move within reach. read more By Andrea Park With these clearances under its belt, Medtronic will begin rolling out the upgraded InPen and the Guardian 4 sensor in Europe later this fall. read more By Angus Liu Researchers in Taiwan have developed a DNA COVID-19 vaccine that’s delivered into cells with some extra help from electrical pulse. The candidate induced high levels of antibody response in animals and protected hamsters against the disease. read more By Fraiser Kansteiner With production on pause and millions of COVID-19 vaccine doses in limbo, Johnson & Johnson has been hustling to right the ship at CDMO Emergent BioSolutions' troubled Baltimore manufacturing facility. Now, it looks like relief is in sight. read more Resources Sponsored by: Clinical Ink For faster deployment, improved patient engagement, and better-quality data — go where your patients are. GO BYOD with Lunexis™ from Clinical Ink. 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: AmerisourceBergen Developing a quality product and getting it approved for distribution is not enough to guarantee commercial success. 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: 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: Within3 We enable virtual work — offering over-time sessions where participants are more focused, insights are more diverse and business goals are met. Sponsored by: Catalent Hear industry experts discuss the recent advances, challenges and considerations in pediatric drug development. Real-life examples presented by the experts illustrate the impact of age-appropriate dose forms for pediatrics and highlight insights into the caregiver perspectives. 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 proven strategies for a successful product launch, including cross-functional team collaboration, risk management and using the right project management tools. | 