Pfizer, BioNTech nab fast track tag, prep for major phase 3 COVID-19 vax test this month FDA spotlights eye safety in GSK anti-BCMA AdComm, but analysts expect approval anyway Merck, Dewpoint unite to find HIV cure in deal worth up to $305M Sponsored: Kupffer Cells in Complex In Vitro Cultures: An Important Tool For Drug Discovery Roche targets 2021 start for hemophilia A gene therapy phase 3 as optimization effort drags on Angelini lands EU rights to Ovid's phase 3 rare disease drug Telegenomics provider Genome Medical raises $14M, plus Samsung Catalyst partnership Featured Story | By Ben Adams Pfizer and German mRNA partner BioNTech have grabbed an FDA fast track label as they look to start a late-stage, 30,000-patient COVID-19 vaccine test before the month is out. read more |
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| | Your clinical packaging strategy is key to a successful trial. When developing your strategy, it’s important to consider your patients' and healthcare providers' needs as well as packaging options and automation. Download our eBook to learn more. |
Top Stories By Amirah Al Idrus The multiple myeloma field is teeming with BCMA-targeting agents, including bispecific antibodies and CAR-T therapies. GlaxoSmithKline’s antibody-drug conjugate could beat the others to market, but first it has to convince an FDA panel that its benefits outweigh eye-related side effects. read more By Amirah Al Idrus In its second pharma deal, Dewpoint Therapeutics is teaming up with Merck to develop a new way to fight HIV using its molecular condensates platform. The duo kept specifics under wraps, but Dewpoint could net up to $305 million in upfront and milestone payments. read more Monday, July 13, 2020 The inclusion of Kupffer cells in in vitro hepatic cultures provides researchers with advanced tools for disease modeling and drug discovery. read more By Nick Paul Taylor Roche has posted updated clinical data on a hemophilia A gene therapy it acquired in its $4.3 billion takeover of Spark Therapeutics. The study linked SPK-8011 to improvements in factor VIII expression and bleeding out as far as 3.3 years after administering the therapy, but, with Spark still optimizing the regimen, it will be 2021 before phase 3 dosing begins. read more By Nick Paul Taylor Ovid Therapeutics has offloaded the European rights to OV101 in a genetic nervous system disorder to Italy’s Angelini Pharma. Angelini is paying $20 million upfront to secure a license to a drug that is due to come through a phase 3 trial in Angelman syndrome by the end of the year. read more By Conor Hale Since expanding its DNA-focused telehealth work into guiding patients and institutions from genetic testing through subsequent specialty care, Genome Medical has raised $14 million to help boost its clinic-focused operations. read more | | Webinar: Metabolites in Safety Testing (MIST): Analytical Strategy Wednesday, July 29 | 1pm ET / 10am PT Regulatory agencies have provided recommendations on when and how to identify and characterize drug metabolites to ensure their non-clinical toxicity has been adequately evaluated. This presentation will review the origins of these recommendations and the specific requirements that need to be considered in designing studies. Register now. |
Resources Sponsored by: Lonza Pharma & Biotech A novel spray-dried dispersion platform has been developed to faciliate high drug load applications Sponsored by: Florence Complimentary Download: How to connect to study sites remotely via the Electronic Investigator Site File (eISF) to streamline clinical operations. Insights from the largest eISF network in the world. Sponsored by: PRA Health Sciences Collaboration across the industry will be key to meeting the demands of the RACE Act and ensuring pediatric patients receive the care and treatments they need. Sponsored by: Cytiva On-demand video: fuel gene therapy development and production with modern AAV workflows. With today’s rapidly evolving environment, we have created this five-part content series to highlight pressing issues and topics that are more pertinent today than ever before. Sponsored by: Cambrex The industry trend of outsourcing to CDMOs continues. With more services, capabilities, facilities, and employees than ever before, our experts have contributed more articles to our biggest eBook yet. Sponsored by: EVERSANA How predictive analytics and machine learning have the potential to transform healthcare by predicting “Patient Switching Behaviors.” Sponsored by: Recro Gainesville Wurster processing is a versatile technique for developing and manufacturing multiparticulates for modified release dosage forms. Read this whitepaper to determine whether Wurster processing is the right option for your project. Sponsored by: Systech Get an inside look… Merck shares its next-generation approach to supply chain protection with new digital platforms, including Blockchain. Sponsored by: Automation Anywhere Built on advances in Artificial Intelligence (AI), data mining, and information integration into various systems at 100% accuracy, the new era of intelligent automation is integral to life sciences for devising new treatments faster and at a lower expense. Sponsored by: Research Solutions Learn four ways to squeeze more value from your limited R&D resources. Sponsored by: BioAnalytix Download this eBook and Learn the Advanced Analytical Approaches for Improved Development of Cell and Gene Therapies 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. The Bioprocessing Summit Virtual – Solving Today’s Challenges, Leading to Tomorrow’s Advances August 24-28, 2020 Drug Development Boot Camp® 2020 November 18-19, 2020 | Register now! Pre-Boot Camp training ongoing now. | COVID19 provisions – training will be on-site as normal. | New – may be possible for some individuals to access the training virtually in real time. | 