FDA slaps clinical hold on AstraZeneca cancer drug amid heart safety scare in combo test Another $80M: mRNA biotech ReCode matches 2020 series A with Pfizer, Sanofi money for cystic fibrosis trial Ventyx nabs a $152M upsized IPO to challenge BMS' Zeposia—and a backer with intimate knowledge of its rival Sponsored: Considerations for Laboratory-Related Operational and Patient Burden in Decentralized Clinical Trials. Clinical Lab Testing in Your Home: Fact or Fiction? Menarini, chased by 3 Big Pharmas, records win in breast cancer phase 3, plots path to FDA GSK-backed Atreca inks license with Gates Medical Research Institute for malaria monoclonal antibody VCs back Leucid to trial CAR-T twist in ovarian cancer patients FDA contracts Aetion’s real-world evidence platform to assess COVID-19 treatments Pfizer strong-armed governments in COVID-19 vaccine supply talks, report says Medtronic issues EU safety warning for Percept PC deep brain stimulation implant Princeton and MIT gene-editing pioneers uncover clues for improving CRISPR and other tools Featured Story | By Ben Adams We found out, via a small and almost unnoticed ClinicalTrials.gov update today, that AstraZeneca suspended trial work on its experimental blood cancer drug AZD5991. Now, we have learned that things are in fact bleaker for the therapy. read more |
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Top Stories By Kyle LaHucik ReCode Therapeutics is back with its second $80 million financing round, this time a series B from Pfizer, Sanofi and VC shops, to bring its lead programs into human trials. Up first are cystic fibrosis and primary ciliary dyskinesia, another lung disease. read more By Ben Adams Ventyx Biosciences is in the fast lane: Less than a year ago, the biotech emerged from stealth with big plans to dampen down some blockbuster autoimmune/inflammation targets. Then last month, it sprinted to Wall Street with the now standard $100 million IPO ticket. 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 Nick Paul Taylor Menarini and Radius Health have gained a lead over AstraZeneca, Roche and Sanofi in the race to bring a new class of oral breast cancer drugs to market, posting phase 3 data and outlining plans to seek approvals on both sides of the Atlantic next year. read more By Kyle LaHucik Oncology biotech Atreca is linking arms with the Bill & Melinda Gates Medical Research Institute to work on a monoclonal antibody for the potential treatment of malaria. The licensing deal comes just two weeks after the WHO signaled a breakthrough in the fight against malaria with a recommendation for broader rollout of GlaxoSmithKline's vaccine. read more By Nick Paul Taylor John Maher has secured funding to put his ideas about CAR-Ts to the test. As chief scientific officer of Leucid Bio, Maher has pushed the idea that the configuration of co-stimulatory modules is the secret to success in CAR-T—and now he has the cash to run a phase 1 clinical trial in ovarian cancer. read more By Rebecca Torrence Clinical trials, though critical to the scientific process, can take a long time, which can be a problem in the face of a public health crisis. The FDA announced today it's partnering with the Aetion Evidence platform, which will allow the agency to analyze data about COVID-19 from real patients in real-time. read more By Eric Sagonowsky Pfizer is playing a leading role in producing vaccines against COVID-19, but new documents released by Public Citizen shine a light on the company's aggressive tactics when negotiating supply deals. read more By Andrea Park Medtronic identified an issue in which its Percept PC deep brain stimulation implant may stop working and need to be removed after an implanted patient undergoes a cardioversion. read more By Angus Liu Scientists at Princeton and MIT, including gene-editing pioneer David Liu, used a new screening method called Repair-seq to identify pathways that affect different outcomes in CRISPR/Cas9, prime editing and base editing. The findings could help design more accurate and efficient gene-editing systems, they say. 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? 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