Ovid flunks Angelman phase 3, leaving field wide open for rivals Janssen buys up eye disorder gene therapy asset from Hemera Biosciences Bayer creates cell and gene therapy platform to support partners Sponsored: Biotech IPOs: New Steps to Success on the Road to Going Public Chinese biotech Zai Lab nabs Roche cancer veteran as new R&D exec, drug hunter Merck opts in for Dragonfly's TriNKET cancer immunotherapy program Restoring eyesight with genetically engineered stem cells Pfizer, BioNTech nab COVID-19 vaccine authorization from U.K. for first-ever marketed mRNA shot Featured Story | By Nick Paul Taylor A phase 3 trial of Ovid Therapeutics’ OV101 in Angelman syndrome has missed its primary endpoint, sending the biotech’s stock down 50%. Ovid has paused most other elements of its OV101 Angelman work in response to the setback and turned its focus to its next most advanced asset, OV935. read more |
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| | The Challenge of Keeping Cool Pharmaceutical drugs must be maintained within strict temperature guidelines to protect the efficacy of the product. Learn about end-to-end temperature management for the clinical supply chain. |
Top Stories By Ben Adams Janssen is tapping little-known and privately held Hemera Biosciences for a new gene therapy aimed at reversing a severe disease. read more By Nick Paul Taylor Bayer has created a cell and gene therapy platform to support its growing pipeline of advanced therapy medicinal products. The platform is intended to enable Bayer to make its expertise and resources available to its partners while preserving their autonomy and culture. read more Sponsored By: RBC Capital Markets 2020 is on track to post the highest number of biotech IPOs in five years. But the pandemic and today’s shifting market have rewritten the rulebook. What are the new best practices for going public? read more By Ben Adams Zai Lab is looking to boost its cancer credentials and pipeline with the appointment of Roche oncology vet Alan Sandler, M.D. read more By Ben Adams Merck is clearly still buzzing about its two-year Dragonfly Therapeutics pact, as it has snapped up a cancer program. read more By Arlene Weintraub Researchers at the Centre for Genomic Regulation in Barcelona are developing a stem cell treatment for retinal degeneration that focuses on two chemokine receptors that play an important role in cell signaling. The altered cells migrated in high numbers to degenerating retinal tissue and preserved its function, they reported. read more By Angus Liu Pfizer and BioNTech have made history. The two companies’ BNT162b2 has become the first COVID-19 vaccine allowed in the Western world as drug regulators in the U.K. doled out an emergency use authorization on Wednesday. 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: 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: 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: 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 | 