Halozyme scores $190M Horizon deal to develop subQ Tepezza formula Wilson, Penn ink Regeneron pact to use gene therapy tech to deliver COVID-19 antibodies Rhythm Pharmaceuticals scores first FDA approval for obesity med targeting genetic defects Kinaset Therapeutics debuts with $40M for pan-JAK asthma med Who's fierce in Medtech? Submit your nominations now for 2020's Fierce 15 Featured Story | By Fraiser Kansteiner Halozyme has struck a licensing deal worth upward of $190 million with Horizon Therapeutics, granting the drugmaker access to Halozyme’s Enhanze drug delivery platform. Horizon will tap Enhanze to develop a subcutaneous formulation of its thyroid eye disease med Tepezza (teprotumumab-trbw), the companies said. read more |
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Top Stories By Ben Adams Gene therapy pioneer Jim Wilson and the University of Pennsylvania are teaming up with Regeneron to help deliver its COVID-19 antibody cocktail using AAV tech in the hope of curbing infection via a nasal spray. read more By Eric Sagonowsky Obesity is a major problem worldwide, but, for a fraction of patients, genetic mutations rather than habits are driving the disease. With its new FDA approval for Imcivree, Rhythm Pharmaceuticals is taking the first step toward treating those cases. read more By Amirah Al Idrus There is a host of treatments for people with asthma, from inhaled and oral corticosteroids to newer injected biologics. But these drugs don’t work for everyone, because different factors cause asthma in different people. Kinaset aims to close the treatment gap with a pan-JAK inhibitor designed to help patients regardless of what’s causing their disease. read more By Conor Hale Nominations are open for private startups and companies from across the globe, whether they’re currently working in COVID-19 or not. read more Resources 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: Veeva New industry-wide research reveals that the quality and breadth of HCP data is imperative as commercial teams adjust to remote engagement and execute a tailored approach. Read the full report to see all findings and benchmark your organization’s progress. 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: 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: Thermo Fisher Scientific One of the best ways to stay on-schedule is to start with a solid understanding of the most common API challenges. Awareness will help you choose a development partner with the ability to solve issues before they affect your timeline. 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: 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. Design Thinking: Innovate4Outcomes December 3, 2020 | Virtual Event Fierce JPM Week January 11–13, 2021, 10AM ET | Virtual Event | 