Agios offloads oncology unit to Servier in $1.8B deal, zeroes in on genetically defined diseases GSK bags rights to Sosei Heptares drugs against untapped digestive disorder target UniQure/CSL hit by FDA clinical hold for hem B gene therapy program after liver cancer find Roche's bispecific matches Regeneron's Eylea in phase 3 trials 2 Nants become one as Soon-Shiong combines NantKwest, ImmunityBio Regeneron scientists target cell recycling to boost cancer immunotherapy Moderna scores FDA authorization for its COVID-19 vaccine, adding key 2nd shot as nationwide campaign ramps up The top 10 M&A targets in medtech Featured Story | By Amirah Al Idrus Agios Pharmaceuticals’ roots are in cancer drug development, but it’s passing that baton to Servier as it doubles down on its programs in genetically defined diseases, including a drug it’s developing for noncancerous blood diseases. The deal will see $1.8 billion changing hands upfront, but the deal could reach $2 billion in value if vorasidenib, a clinical-stage asset, hits certain goals. read more |
| |
|---|
|
Top Stories By Nick Paul Taylor GlaxoSmithKline has struck a backloaded $481 million deal with Sosei Heptares to secure the rights to a potential therapy for inflammatory bowel disease and related conditions. The agreement gives GSK global rights to a portfolio of GPR35 agonists discovered by Sosei. read more By Ben Adams Just two weeks after showing off positive results at the American Society of Hematology meeting, uniQure and partner CSL have been hit with an FDA clinical hold for their bleeding disease treatment etranacogene dezaparvovec. read more By Nick Paul Taylor Roche’s VEGFxAng2 bispecific antibody faricimab has matched Regeneron’s blockbuster Eylea in two phase 3 diabetic macular edema clinical trials. Faricimab was non-inferior to Eylea despite people on the experimental drug transitioning to a 16-week dosing window during the study. read more By Amirah Al Idrus Patrick Soon-Shiong’s NantKwest made a splash in 2015 with its $207 million IPO, but five years on, it’s becoming the vehicle for fellow Nant company ImmunityBio to go public. Slated to close in the first half of 2021, the all-stock deal will see ImmunityBio shareholders owning nearly three-quarters of the combined company (72%), with NantKwest shareholders holding the remaining 28%. read more By Angus Liu The cellular recycling process known as autophagy is important for cell survival. But scientists at Regeneron have found that autophagy can also protect tumor cells from immune attack. Deleting an autophagy gene made tumors more vulnerable to the blocking of the immune checkpoints PD-1 and CTLA-4 in mice, the team showed. read more By Eric Sagonowsky When COVID-19 began spreading earlier this year, the prospect of coronavirus vaccines launching before year’s end seemed like the longest of long shots. Now, partly in thanks to the research partnership between the federal government and industry, the U.S. has its second authorized COVID-19 vaccine. scores FDA nod for its COVID shot, adding key 2nd option read more By Conor Hale Many of our top M&A targets offer unique solutions through AI, sensors and the cloud to make medical technologies more portable, so providers can go to where the patients are and not the other way around—which may be essential as COVID-19 continues to change the landscape. read more Resources 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: Metabolon Learn six ways metabolomics provides greater confidence, higher success rates and complements the work of your in-house teams for your drug development pipeline. Sponsored by: ZS Learn how Aerie fueled their product launches with advanced analytics. Sponsored By: Elligo Health Research® Understanding the Challenges COVID-19 Pediatric Clinical Trials Face | White Paper Sponsored By: Thermo Fisher Scientific Lack of resources to move from lab concept to the manufacture/delivery of GMP clinical supplies to patients, key milestones can be missed. Sponsored by: Cytiva Human pluripotent stem cells (PSCs) have huge potential to produce cell therapies for many clinical areas. Here we describe a controlled, automated, and defined manufacturing process to fuel demand. 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: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored By: BBK Worldwide The BBK Worldwide Study Voices 2020 survey gives voice to the healthcare consumer in the wake of COVID-19 and reveals important insights for clinical trial enrollment and engagement. Sponsored By: BioAnalytix Download this eBook and Learn the Advantages of LC-MS based HCP Profiling for Development of Complex Biologics. 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: 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: Lonza Liquid-filled hard capsule formulations offer unique options for the manufacture and dosing of highly potent actives. 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: 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: 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: 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 Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Fierce JPM Week January 11–13, 2021, 10AM ET | Virtual Event Virtual Clinical Trials Summit February 9-10, 2021 | Virtual Event | 