UPDATE: CRISPR hails safety, efficacy of off-the-shelf CAR-Ts, but stock slides amid durability doubts Intellia beefs up ocular pipeline with 10% stake in SparingVision Takeda bets up to $900M on Immusoft's cell therapies for neurometabolic disorders Sponsored: Purify DNA, RNA, proteins, and cells for many applications Axial Therapeutics tops up funding for phase 2 autism trial with $37M series C Sponsored: Partnership to unlock the full potential of data to advance the science and practice of healthcare: Q&A with Syntropy and the University of California, Irvine Regulus picks another horse in kidney disease in latest attempt to get pipeline back on track BioNova leapfrogs into the clinic with $200M Sutro blood cancer pact Apnimed sees positives in midstage data for its attempt at drugging the sleep apnea problem Aum bags $27M to hit cancer targets pursued by Bayer, Roche Ardelyx axes 65% of workforce with no clarity from FDA on kidney drug's future Eli Lilly's Verzenio snags first-in-class FDA approval for early breast cancer. But limited label poses a challenge Hospitals have spent more than $3B on personal protective equipment since COVID-19 began Broad Institute looks to Intel, Google Cloud to upgrade genomic data processing Barriers exist, but participation urgent in breast cancer clinical trials: report Featured Story | By Nick Paul Taylor CRISPR Therapeutics’ off-the-shelf CAR-T therapy has fallen short of the high bar set by investors. The prospect triggered responses in 58% of patients without causing grade 3 or higher cytokine release syndrome, but six-month durability compared unfavorably to rival drugs, sending shares in the biotech down 8%. read more |
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Top Stories By Kyle LaHucik Intellia Therapeutics was the first to prove gene editing can work in a human and now the famed CRISPR/Cas9 biotech is beefing up its ocular disease pipeline with a 10% equity stake in SparingVision. read more By Kyle LaHucik Takeda will pay an undisclosed upfront amount and up to $900 million in total value to Immusoft for cell therapies that tackle neurometabolic disorders. The Seattle biotech's platform is based on B cells that aim to induce sustained protein delivery for rare diseases. read more Sponsored by: Thermo Fisher Scientific Discover ways your Thermo Scientific™ KingFisher™ system can empower your research beyond SARS-CoV-2. read more By Kyle LaHucik Axial Therapeutics has picked up $37.3 million to bankroll a midstage test in autism and fund further work on neurological diseases. The Woburn, Massachusetts-based biotech began the phase 2b study in August and expects primary completion next December. read more Sponsored by: Syntropy Q&A with Syntropy and UCI on their collaboration to work across their enterprise and with external partners to advance health research and patient care. read more By Emmy Lucas Regulus Therapeutics is once again shuffling its pipeline and sliding a new kidney disease candidate into the high-priority queue, hoping for better fortunes after a string of failures and shifting priorities. read more By Kyle LaHucik BioNova wants in on Sutro Biopharma's phase 1 antibody-drug conjugate for hematologic cancers and will pay up to $200 million to develop and commercialize the asset in greater China. read more By Ben Adams Just a few months after a modest $25 million raise, little Apnimed has released some broadly positive data for its experimental sleep apnea drug. read more By Nick Paul Taylor Aum Biosciences is moving on to oncology turf targeted by companies including Bayer and Roche, securing $27 million to take inhibitors of MNK and TRK into midphase clinical trials. read more By Kyle LaHucik Ardelyx cut 83 jobs in August and is now slashing another 102 following a meeting with the FDA in which the agency gave the biopharma no clarity on the future of its chronic kidney disease drug. read more By Angus Liu As a late entrant in the breast cancer race, Eli Lilly has leapt ahead of rivals Pfizer and Novartis with a first-in-class FDA approval for Verzenio. But a patient population restriction is adding what Lilly Oncology chief called “a legitimate challenge” to the launch. read more By Dave Muoio Providers' PPE expenses peaked during the second quarter of 2020 due to high demand and increased prices, according to a Premier Inc. analysis. Spending has "steadily declined" since then, but still remains well above pre-pandemic averages. read more By Andrea Park After half a decade of working together to develop software to support genomic research, Intel and the Broad Institute of MIT and Harvard are taking their relationship to the next level. read more By Kyle LaHucik Online community Breastcancer.org is encouraging more racial and ethnic diversity in clinical trials of treatments for breast cancer. Multiple barriers exist to preventing people of color from entering clinical trials, and many recent approved treatments for the indication have had low rates of Black and Hispanic patients in trials. read more Resources Sponsored By: Unlearn AI Read Unlearn’s whitepaper to learn about how novel trial designs with Digital Twins enable more efficient clinical trials, with higher power and smaller required sample sizes. Sponsored By: Trial Interactive Check out the eTMF Implementation Quick Guide to see a checklist TMF experts developed to help you reduce risks, maintain compliance, and establish effective processes in your eTMF. Sponsored By: Bioclinica This whitepaper addresses where AI can make the biggest impact in clinical trials. Sponsored by: Thermo Fisher Scientific Looking to accelerate your biotech company, but not sure where to start? Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. 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: Oracle Health Sciences New research indicates an accelerated adoption of decentralized clinical trials due to COVID-19. Sponsored by: LabVantage Solutions Shift from data collection to data science. Add advanced analytics to your lab informatics platform to yield valuable, action-ready insights from LIMS and other data. 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: Thermo Fisher Scientific Integrate supply chain simulation into your early clinical trial planning to minimize risk in an uncertain supply chain environment, improve supply chain outcomes, and help streamline time-to-market for innovative therapies. Sponsored by: WCG Every biopharma sponsor faces the challenge of initiating, running and closing trials on time, but oncology studies pose several unique hurdles. 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. 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