Roche to pay Blueprint $775M for pralsetinib rights, setting up showdown with Lilly Sanofi, MD Anderson join forces to ramp up cancer R&D FDA panel to chew over endpoint, safety strategies for Mallinckrodt’s terlipressin Sponsored: Kupffer Cells in Complex In Vitro Cultures: An Important Tool For Drug Discovery FDA spurns CytoDyn's HIV drug because of missing info Junshi taps Revitope for next-gen anticancer bispecifics Mahanthappa graduates from Scholar Rock, hires Taris CEO Kingsley as new chief A 'safety switch' for cell therapy based on nutrient deprivation electroCore’s nerve stimulator authorized for asthma patients facing COVID-19 The top 15 pharma companies by 2026 sales Featured Story | By Nick Paul Taylor Roche is paying Blueprint Medicines $775 million upfront for rights to RET inhibitor pralsetinib. The deal sets Roche up to compete with Eli Lilly for patients with RET fusion-positive tumors of organs including the lung and thyroid. 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 Immuno-oncology drugs such as checkpoint inhibitors have transformed cancer treatment for some patients—the key word being “some.” Sanofi aims to understand why these drugs work for some patients and not others, and it’s teaming up with the MD Anderson Cancer Center to do it. read more By Amirah Al Idrus Mallinckrodt unveiled phase 3 data in November showing its rare disease med terlipressin beat placebo at reversing a type of kidney failure. An FDA panel will convene on Wednesday to help the agency decide the drug’s fate—and their key question will be about the study’s surrogate endpoint. 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 Amirah Al Idrus The FDA rejected CytoDyn’s application for its lead program, a treatment for HIV, because it’s missing some information, the company announced Monday. The refusal-to-file letter comes two months after the company revealed it had previously sent the wrong data sets to the agency. read more By Nick Paul Taylor Junshi Biosciences has struck a deal to source T-cell engaging antibodies from Revitope Oncology. The deal, which is worth up to $160 million per molecule in milestones, comes as Junshi tries to pull off a $684 million IPO to fund development of a broad pipeline of therapeutics. read more By Ben Adams After eight years at the helm, Scholar Rock’s founding CEO Nagesh Mahanthappa, Ph.D., is stepping down from the biotech to become its scientific adviser. read more By Arlene Weintraub Startup Auxolytic is developing a “safety switch” for cell therapy that hinges on depriving engineered immune cells of the nutrient uridine, which they need to grow and proliferate. The technique inactivated transplanted T cells in mice, preventing a potentially dangerous rejection response. read more By Conor Hale The bioelectric therapy developer electroCore received an agency green light for its vagus nerve stimulation device, aimed at reducing exacerbations in people potentially affected by the novel coronavirus and have difficulty breathing due to asthma. read more By Eric Sagonowsky As the pharma industry enters a new decade, the world's largest drug companies are busy launching new meds, restructuring to focus on innovative offerings and eyeing new technologies. And despite challenges from the COVID-19 pandemic, analysts see growth ahead for many of them. 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. | 