In a test for Hahn's FDA, Biogen submits controversial Alzheimer's drug aducanumab Merck teams up with cancer startup Foghorn in $425M deal Sanofi licenses Kiadis' NK cells to boost efficacy of rival to J&J's Darzalex Sponsored: Keep post-pandemic trials on track: how the right clinical supply chain partner helps sponsors avoid trial disruption, now and going forward Gilead axes $445M Precision Biosciences gene therapy hep B pact French biotech Osivax nabs funding boost for universal flu, coronavirus vaccine work Propeller's digital inhaler tech to be co-prescribed with Novartis' new asthma med Fine-tuning regulatory T cells to treat cancer and autoimmune diseases Featured Story | By Amirah Al Idrus It took a little longer than expected, but Biogen’s done it—along with partner Eisai, the Big Biotech has completed an FDA filing for aducanumab, the Alzheimer’s drug it resurrected just in time for Halloween. Aducanumab’s fate will be a test of how far Stephen Hahn's FDA is willing to diverge from its established approval standards. read more |
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Top Stories By Ben Adams Two years after its official launch, next-gen cancer biotech Foghorn Therapeutics has nabbed a biobucks deal with Big Pharma Merck. read more By Nick Paul Taylor Sanofi has licensed natural killer cells from Kiadis Pharma to use in combination with its multiple myeloma drug Sarclisa. The backloaded, €875 million ($986 million) deal gives Sanofi global rights to therapies that could mitigate an efficacy-limiting shortcoming of anti-CD38 antibodies. read more Monday, July 6, 2020 Facing a new reality, pharma and biotech companies must address ongoing clinical trial distribution challenges. Here's how a supply chain partner can help keep your post-pandemic clinical program on track. read more By Ben Adams Gilead is ditching a new avenue of treating hepatitis B as it cuts ties with Precision Biosciences less than two years into their research pact. read more By Ben Adams Little Lyon biotech Osivax has grabbed €30 million ($33.8 million) for its universal coronavirus and influenza inoculations. read more By Conor Hale Novartis has teamed up with smart inhaler developer Propeller Health to package and ship its digital medication-tracking platform alongside the Big Pharma’s newly approved asthma treatment in Europe. read more By Angus Liu Regulatory T cells play a key role in modulating other cells in the immune system. Scientists at the Salk Institute for Biological Studies pinpointed genes that they believe could be used to fine-tune the activity of these cells to treat cancer and autoimmune diseases. read more Resources 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: 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: 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. 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. | 