Merck bags solid tumor CAR-NKs from Artiva to push into cell therapy Medigene shares sag as it axes TCR-T blood cancer drug, with COVID-19 partly to blame Lilly lands clinical-phase pain drug via deal with Asahi Kasei WCLC: Takeda's new kinase inhibitor curbs 78% of lung cancers with rare EGFR mutation Roche joins Sofinnova, AbbVie in Enthera's €35M venture round AstraZeneca, BenevolentAI home in on computer-generated target for chronic kidney disease drugs Cancer drug derived from sea squirts outperforms remdesivir in COVID-19 preclinical models Featured Story | By Nick Paul Taylor Merck has secured global licenses to two CAR-NK programs from Artiva Biotherapeutics. The deal gives Merck control of two off-the-shelf solid tumor cell therapies in return for $30 million upfront and potentially many times that in milestones. read more |
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Top Stories By Ben Adams German biotech Medigene saw its shares down 7% Thursday after it decided to cull one of its TCR-T cancer assets after delays by COVID-19 restrictions hampered its efforts. read more By Nick Paul Taylor Eli Lilly has struck a deal to buy the near-global rights to a P2X7 receptor antagonist from Asahi Kasei Pharma. The agreement will give Lilly control of a treatment for neuroinflammatory pain conditions that recently completed phase 1 studies. read more By Amirah Al Idrus EGFR inhibitors like AstraZeneca’s Tagrisso and Genentech’s Tarceva have been on the market for years to treat patients with lung cancer. But those drugs are designed to treat patients with specific mutations and one patient group with a rare type of EGFR mutation has fallen through the cracks. With promising phase 1/2 data, Takeda is one step closer to providing those patients with a targeted treatment. read more By Amirah Al Idrus Roche’s venture arm is joining the likes of Sofinnova Partners and AbbVie in backing Italy’s Enthera Pharmaceuticals, bringing the diabetes-focused biotech’s series A round to €35 million ($42 million). The funding will bankroll the company's lead program, Ent001, to clinical proof of concept. read more By Conor Hale After launching a collaboration nearly two years ago to bring artificial intelligence to kidney drug design, AstraZeneca and BenevolentAI believe they’ve discovered a winner. read more By Angus Liu The search among existing drugs for potential COVID-19 treatments has pointed to another promising candidate—PharmaMar’s myeloma drug plitidepsin. In preclinical studies, it performed better than Gilead Sciences’ FDA-approved remdesivir against the SARS-CoV-2 virus behind the disease and was even effective against a more contagious variant. read more | | Experts in our field with 20+ yrs. experience in Viral Vector & Plasmid DNA (R&D, “HQ” High Quality, GMP) manufacture. Now part of the Cognate BioServices family, Your CDMO partner from concept to commercial for cell & gene therapy products. Learn more. |
Resources Sponsored by: Cytiva It’s an exciting time to pioneer what could be a life-changing medicine. Clear the path to the clinic with pro tips and expert insights from industry leaders. Sponsored By: Polpharma Biologics Innovative cell lines and early process development are critical to generate a high producing cell lines alongside a USP strategy to meet high quality standards. Sponsored By: Blue Matter Biopharma companies in rare diseases: How to maximize the odds of success by becoming a valued member of the unique “rare disease ecosystem.” Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process development and manufacturing of your novel molecule Sponsored by: GenScript A significant number of new treatments have been approved so far, but some manufacturing and regulatory guidelines pose challenges for advanced therapies, leading to poor production yields. Sponsored by: Catalent Cell and gene therapies hold the promise to offer novel therapeutic avenues for individuals facing serious medical conditions, but bringing them through the clinical trial process introduces a level of supply chain risk and complexity. Sponsored by: AllianceRx Walgreens Prime Gene and cell therapy are shifting paradigms for manufacturers, patients, healthcare providers and pharmacies. We invite you to learn more by reading Gene and Cell Therapy: A New Age of Medicine. 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: Covance Download the whitepaper to learn how your safety organization can implement automation technologies to enable process and cost efficiencies, improve resource allocation and ensure compliance and quality. Sponsored by: Premier Research Browse the latest learnings and insights from our clinical development professionals. Sponsored by: Rousselot This infographic describes the benefits of GelMA in various biomedical applications and how X-Pure® GelMA can help you in your developments. 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 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: 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 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. Fierce JPM Week January 11–13, 2021, 10AM ET | Virtual Event Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Virtual Clinical Trials Summit February 9-10, 2021 | Virtual Event Learn what it takes to get a drug developed and approved February 23-24, 2021 | 9:00am-3:30pm PST For non-scientists. Learn the science driving biopharma. February 25-26, 2021 | 9:00am-3:30pm EST Learn what it takes to get a drug developed and approved March 9-10, 2021| 9:00am-3:30pm EST Learn the science driving biopharma. Specific for the non-scientist. March 18-19, 2021 | 9:00am-3:30pm PST Learn what it takes to get a drug developed and approved April 13-14, 2021 | 9:00am-3:30pm PST
Learn the science driving biopharma. Specific for the non-scientist. April 20-21, 2021 | 9:00am-3:30pm PST Learn what it takes to get a drug developed and approved April 22-23, 2021 | 9:00am-3:30pm EST Learn the science driving biopharma. Specific for the non-scientist. May 6-7, 2021 | 9:00am-3:30pm EST Vaccines, cell and gene therapy, therapeutic antibodies and RNA drugs May 20-21, 2021 | 9:00am-3:30pm PST Learn what it takes to get a drug developed and approved June 2-3, 2021 | 9:00am-3:30pm EST Vaccines, cell and gene therapy, antibodies, and RNA-based drugs June 10-11, 2021 | 9:00am-3:30pm EST | 