Amid Amgen's similar struggles, AstraZeneca slams the brakes on MCL-1 blood cancer drug Stealth's not so sneaky strategy to file unprepared drug application foiled by FDA F-star shoots for the moon with massive $1.35B J&J biobucks deal for 5 bispecifics Sponsored: Considerations for Laboratory-Related Operational and Patient Burden in Decentralized Clinical Trials. Clinical Lab Testing in Your Home: Fact or Fiction? Galera shares slide nearly 70% as radiotherapy complication drug flunks out of phase 3 Receptos founder returns with ShouTi and $100M for oral drugs to treat chronic diseases Chase, after selling last biotech to Allergan, gets cash to start pivotal trials in depression, Parkinson's Takeda crashes out of Wave discovery pact at cost of $23M Injured tumor cells activate immuno-oncology drugs to combat breast cancer and melanoma in mice Intrivo launches at-home COVID test that returns results in 10 minutes via AI-powered app Security flaws in health apps, APIs potentially put millions of patient records at risk, report finds Failed cancer immunotherapies cost Medicare hundreds of millions. How should FDA revamp accelerated approvals? Featured Story | By Ben Adams AstraZeneca has paused an active phase 1 trial of AZD5991, a direct inhibitor of MCL-1, citing the need to suss out a potential safety issue. read more |
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Top Stories By Annalee Armstrong It was a bold strategy, filing a drug the FDA clearly said was not ready for prime time, but Stealth BioTherapeutics did it anyway. Today, its chickens have come home to roost. read more By Kyle LaHucik Add Johnson & Johnson's Janssen Biotech to the list of Big Pharmas lining up at the doors of 2011 Fierce 15 winner F-star Therapeutics. The $17.5 million upfront, $1.35 billion biobucks pact grants Janssen an exclusive license to up to five novel bispecific antibodies. read more Sponsored by: Q2 Solutions Clinical lab testing at home - fact or fiction? Many operational and patient-related considerations must be taken when using a decentralized approach to specimen collection at or near the trial participant's home. read more By Annalee Armstrong Galera Therapeutics’ drug for a radiotherapy complication failed to reduce incidences of the debilitating condition called severe oral mucositis during a phase 3 trial. read more By Kyle LaHucik ShouTi raised $100 million in series B funds to bankroll clinical trials of its oral, small-molecule treatments in chronic diseases spanning cardiovascular, metabolic and pulmonary conditions. The San Francisco and Shanghai biotech has raised $158 million since its 2019 inception. read more By Nick Paul Taylor Chase Therapeutics is heading into pivotal trials. Armed with $20 million, the biotech plans to start phase 3 clinical trials of candidates based on an old Boehringer Ingelheim drug in major depressive disorder (MDD) and Parkinson’s disease. read more By Nick Paul Taylor Takeda’s interest in Wave Life Sciences’ discovery programs has ebbed, leading it to exit that part of its alliance with the biotech while keeping the option to license a trio of more advanced programs. read more By Arlene Weintraub Scientists at the MIT Center for Precision Cancer Medicine developed a method for removing tumor cells, treating them with chemotherapy and then combining them with checkpoint-inhibiting drugs to stimulate an immune attack against cancer. In mouse models of melanoma and breast cancer, the technique eliminated 40% of tumors, they reported. read more By Andrea Park There’s an app for just about everything these days—including, now, to generate the results of an at-home COVID-19 test. read more By Rebecca Torrence Even when electronic health record systems are secure, the apps and aggregators using them may not be. In a new report, "recovering hacker" Alissa Knight tested the vulnerability of three interfaces linking EHR servers to third-party aggregators—and gained access to 4 million records with a single login. read more By Angus Liu A recent FDA review of past conditional go-aheads for cancer immunotherapies has led to several withdrawals. Health policy and economics researchers see the campaign as another opportunity to push for a revamp of the agency’s accelerated approval pathway. read more Resources Sponsored by: Thermo Fisher Scientific Learn how to develop a high-performing supply chain for cGMP chemicals used throughout your biologics workflow. Download the free whitepaper from Thermo Fisher Scientific 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: 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: 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. 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