| Scout Clinical helps remove the financial and logistical burdens for clinical trial participants. We offer personalized and adaptable patient payment and travel services globally. Learn more: Scout Clinical | Services! | Leading longevity researcher accused of sexual harassment Aprea gets 2nd clinical hold in a week, this time for lymphoid malignancy study Merck NK cell ally Artiva splashes out on new digs in San Diego From 'party drug' to ayahuasca to 'Sally D': ATAI sets up next shop for treating mental health Debut Biotech makes its entrance with a $22M series A for cell-free biomanufacturing facility Overcoming resistance to cancer immunotherapy by targeting garbage-cleaning cells in tumors Moderna's sky-high market value 'unjustifiable' to one analyst, story stock to another as it tops the likes of Merck and Amgen HIMSS21 Roundup—Epic rolls out customer story-sharing site; Young inventor's advice for health tech innovators Featured Story By Nick Paul Taylor Until this week, Aubrey de Grey was best known as the longevity researcher who predicted the first human to live 1,000 years may already be alive. Now, de Grey stands accused of being a sexual predator. read more |
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| Top Stories By Ben Adams Aprea saw its shares slide into the red today as the FDA doubled down on icing its trial work. In a brief statement, the biotech said the FDA has placed a clinical hold on a test of eprenetapopt with AstraZeneca’s Calquence, or with Roche/AbbVie’s Venclexta and Roche/Biogen’s Rituxan, in lymphoid malignancies. read more By Nick Paul Taylor In the challenging, capacity-constrained cell therapy sector, the multiyear move toward leaner, more virtual models of drug development is reversing. Now, biotechs want their own infrastructure—and are taking out leases to secure the ability to do work in-house. read more By Kyle LaHucik Another day, another subsidiary for mental health treatments. ATAI Life Sciences unveiled Revixia, which will investigate a psychoactive plant from the mint family in potentially treating treatment-resistant depression, substance use disorder and pain. read more By Kyle LaHucik Debut Biotech wants to be the next leading biomanufacturer but with a cell-free approach to commercializing ingredients for food and wellness products, cosmetics, colors, therapeutics and other areas. Investors are buying into the idea with $22.6 million to help build a facility in San Diego. read more By Angus Liu Combining immunotherapy, anti-angiogenic drugs and chemotherapy to treat non-small cell lung cancer hasn't proven to be all that effective. Now, a new study suggests that a four-drug combination including a CSF1R inhibitor can target tumor-associated macrophages and improve the anti-tumor response. read more By Noah Higgins-Dunn Moderna's record-breaking $200 billion market value earlier this week has split Wall Street as one analyst says it's gone from "unreasonable to ridiculous." read more By Heather Landi,Dave Muoio Here are a few slices of news and life from the first day of the 2021 Healthcare Information and Management Systems Society (HIMSS) Global Health Conference and Exhibition on Monday. read more | Looking for a simple and cost-effective solution to scalable production of ESCs and iPSCs? Learn how growing pluripotent stem cells in suspension enables scaling up without scaling out while saving time and cost. Download our free PSC suspension culture infographic | Resources Sponsored By: Patheon Pharmaceutical Services Inc. Learn how to build a robust packaging strategy and the key technical considerations in packaging design and operational planning to enable rapid commercialization of pharmaceuticals. Sponsored by: Patheon by Thermo Fisher Scientific Learn how a decentralized clinical trial strategy improves patient recruitment, reduces drop-out rates, and ultimately streamlines the path to the next trial phase. Sponsored by: Patheon by Thermo Fisher Scientific Learn how regulations are changing and key considerations for commercializing cell and gene therapies without sacrificing quality. Sponsored By: LabVantage Solutions, Inc. Uncover the real impact of “digital transformation” with practical advice to help you plan your own transformative journey to a harmonized digital ecosystem. Sponsored by: Box Read Get to Know Cloud Content Management for Life Sciences and learn how to eliminate silos across all workflows, from R&D to commercialization. Sponsored by: Evidera, a PDD business Learn about key post-marketing safety study solutions, including registries and REMS, and how they can most effectively help meet regulatory requirements and maximize patient access. Sponsored by: Cytiva A one-stop hub for Cytiva resources to support process intesification Sponsored By: Remarque Systems Remarque Systems consolidates data, then layers on visualization and automated metrics to generate consistent, actionable data insights in real-time. Click here for more info. 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 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. Drug Development Boot Camp® 2021 Onsite and VIRTUAL in real time November 17-18, 2021 | Register now! Pre-Boot Camp preparation is now available. Medical Affairs Strategic Summit (MASS) September 13-15, 2021 | New Brunswick, NJ Clinical Quality Oversight Forum September 27-29, 2021 | Philadelphia, PA Diversity, Equity & Inclusion Week November 9–11, 2021 | Virtual Event Fierce Biotech Forum Boston, MA | November 16-17, 2021 |