Bayer to pay $2B upfront for AskBio to drive gene therapy expansion Mirati's KRAS drug shrinks 45% of NSCLC tumors, putting it in Amgen's slipstream on race to FDA AstraZeneca's U.S. COVID-19 trial is back on track after 45-day hold Forma Therapeutics' IDH1 blocker banishes leukemia in 33% of patients KSQ boosts PARP inhibition in animal models of ovarian and breast cancers with USP1 inhibitor Celltrion nabs emergency use for rapid COVID-19 test from FDA The 20 most influential people in the fight against COVID-19 Featured Story | By Nick Paul Taylor Bayer has struck a deal to acquire Asklepios BioPharmaceutical for $2 billion upfront. The deal, which features an additional $2 billion in milestones, will give Bayer control of an adeno-associated virus (AAV) gene therapy platform and a pipeline led by clinical-phase treatments for Parkinson’s, Pompe disease and congestive heart failure. read more |
| |
|---|
|
Top Stories By Nick Paul Taylor Mirati Therapeutics’ KRAS drug MRTX849 has triggered responses in 45% of patients with non-small cell lung cancer. The result, which beats the 35% reported by KRAS rival Amgen, sets Mirati up to file for FDA approval of the drug in the second half of next year. read more By Amirah Al Idrus It’s been a minute, but AstraZeneca has gotten the FDA’s all-clear to restart the U.S. study of its COVID-19 vaccine. The British pharma slammed the brakes on the program in early September when a patient in the U.K. developed an inflammatory side effect. The pause came just one week after the 30,000-patient U.S. trial kicked off. read more By Amirah Al Idrus On the heels of a $278 million IPO, Forma Therapeutics is inching toward its first FDA filing. Its lead asset, an IDH1 inhibitor, cleared cancer in one-third of patients with acute myeloid leukemia that had returned despite undergoing treatment or who did not respond to treatment in the first place. read more By Arlene Weintraub KSQ Therapeutics is developing a first-in-class drug that inhibits USP1, an enzyme that promotes the survival of cancer cells by facilitating DNA repair. In mouse models of breast and ovarian cancers, combining the drug with Merck and AstraZeneca's PARP inhibitor Lynparza was more effective than either drug on its own, KSQ reported. read more By Ben Adams Celltrion has nabbed a speedy preapproval for its quick pandemic virus test as it forecasts high demand. read more By Eric Sagonowsky For the pharma world, the pandemic has been a crisis with a purpose. Scientists, regulators, biotech companies and drugmakers large and small have taken center stage as they hunt for drugs, vaccines, diagnostic tests and other aids in halting the pandemic. We've chosen 20 of the people who hold our COVID-19 future in their hands. read more Resources Sponsored By: Paysign In this case study on the Alec Smith Insulin Affordability Act, you will learn not just about the law but about the portal platform designed to change the entire process for manufacturers, pharmacists, and patients. Sponsored By: Veeva Learn how to plan immersive digital event experiences Sponsored by: Aldevron Gene and cell therapy organizations are asked to balance the need for rapid clinical progression and stringent quality expectations throughout development. In this document, Aldevron provides an in-depth look at preparing for plasmid manufacturing based on our years of experience. Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper Sponsored By: Outer Edge Technology A sound Cloud Strategy provides the flexibility and tools businesses need to quickly adapt and operate securely in an ever-changing remote work environment. Learn how your company can cost-effectively empower its employees to be productive and secure while working remotely. Sponsored By: ICON Clinical Research Ltd The culture of clinical research is evolving from one directed by researchers to one driven by the needs of patients and those who care for them. Sponsored By: The PerkinElmer Signals Screening Team Creating integrated HCS workflows in a single platform increases accuracy; reduces time and helps to identify the most appropriate hits or drug candidates. Learn more about a reliable method for creating a more efficient, faster, 3D image and multi-parametric data analysis workflow. 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: Cascade Chemistry, API CDMO Struggling with complex chemistry to get APIs for clinical trials? Find out what to look for in an API CDMO partner to gain expertise and speed that lead to success. Sponsored by: EVERSANA An integrated compliance model can be the competitive differentiator to commercialization and move the needle from cost center to value. Learn How. 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. Sponsored by: Catalent This eBook provides insights on key approaches and considerations for preparing your drug development program for long-term success. Sponsored by: Catalent In this webinar, pharmaceutical scientists present real-life examples of challenges they’ve overcome in the transfer of oral small molecules from a dedicated early-phase development site to a dedicated late-phase manufacturing site. Sponsored by: Formedix Learn how to save time and reduce costs and complexity by streamlining the clinical trial process. Sponsored by: LabVantage Want to leapfrog lengthy LIMS deployments and position your pharmaceutical lab for success? Find out how with LabVantage Solutions. Sponsored by: Thermo Fisher Scientific Learn how to safeguard supply, improve distribution and reduce program costs and risks Sponsored by: Clinical Ink Learn how the right data capture solution can prompt the patient to follow the correct procedures and automatically sort the responses, according to protocol. Sponsored by: Guidehouse While COVID-19 has shifted the rules of the healthcare industry, research shows there was already progress on changes being made for how pharma companies are launching products. Sponsored by: Blue Matter Consulting Senior executives from 16 biopharma companies share their thoughts on how COVID-19 will change how the industry engages with its customers. A complete Life Science Industry Snapshot in One Report Sponsored by: Outer Edge Technology Cybercriminals Are Actively Exploiting The Coronavirus Pandemic To Gain Entry To Enterprise Networks. Don’t Let Your Company Become The Next Ransomware Headline -- Make These Changes Now! 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 Pharmaceutical and biotech companies are spending years developing drugs or promising new biologics, all with the hopes of saving or enhancing patients’ lives. It’s a “race to the finish” in some cases, and the quicker a company can get its product to patients, the better. 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 about a real-world example of how clinical supply management expertise was applied to overcome inventory challenges for a complex, global study. Sponsored by: Catalent Whether a study is simple or highly complex, forecasting and simulation reports serve as data driven communication tools to help minimize risks and keep the study on track. Learn more about forecasting solutions for informed decision making and supporting contingency planning for clinical study. 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 Immersion: Live, Online Course October 21-22, 2020 | 9am - 3:30pm ET Become Fluent In Drug Development With Our Industry Expert October 21-22, 2020 | 9am - 3:30pm ET Learn How To Bring A Drug Successfully To Market Oct 21-22, 2020 | Live, Online BioBasics 101: The Biology of Biotech for the Non-Scientist: Live, Online Course November 12-13, 2020 | 9am - 3:30pm ET Drug Development Boot Camp® VIRTUAL 2020 November 18-19, 2020 | Register now! Pre-Boot Camp training ongoing now | Due to COVID19 provisions – training will be conducted VIRTUALLY | Same excellent total immersion training in new medicine development will be made available to experts who want to make a difference to patients. | 