| Featured Story | By Nick Paul Taylor Applied Genetic Technologies Corporation has run into safety problems after escalating the dose in its pediatric gene therapy trial. Sixty percent of subjects in the small high-dose cohort suffered suspected unexpected serious adverse reactions after being treated for a rare eye disease. read more |
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Top Stories By Annalee Armstrong Capricor Therapeutics’ Duchenne muscular dystrophy therapy appears to have slowed disease progression in older boys and young men who are in the later stages of their disease and unable to walk, setting the biotech up for a phase 3 trial. read more By Annalee Armstrong If CytoDyn’s management can’t get their lead treatment approved, a group of very optimistic investors want to give it a try. After weeks of very public infighting at the Vancouver, Washington-based biotech, a stockholder group has come forward with a strategic plan to get leronlimab approved in a cancer indication. read more Sponsored By: RBC Capital Markets Gene editing is at the new frontier of biotech innovation, driving capital investments and momentum within the IPO market. Learn more. read more By Nick Paul Taylor Bavarian Nordic has secured support to make a late move for the COVID-19 vaccine market. Having missed out on the first phase of the global vaccination campaign, Bavarian Nordic is set to receive up to 800 million Danish krone ($126 million) from the Danish government to muscle in on the booster market. read more Sponsored by: IPM.ai Rare diseases demand a modern recruitment approach grounded in uncovering the ideal, medically-eligible patient population with the highest propensity for study enrollment and retention. read more By Kyle LaHucik After about a year at Roivant Sciences, Roger Sidhu, M.D., is headed for the exit to take up the chief medical officer post at a smaller biotech, Brooklyn ImmunoTherapeutics. read more By Angus Liu A research team led by scientists at the Max Planck Institute for Heart and Lung Research has proposed a promising new method to give the heart regenerative capabilities. It involves transiently returning adult cardiomyocytes to a fetal-like state by selectively expressing four genes. read more By Andrea Park On their own, a group of physicians achieved an average accuracy of 92% when they reviewed a set of more than 600 breast exams—a number that jumped to 96% when aided by the AI model. The number of false positives dropped by a whopping 37%. read more By Kevin Dunleavy In endorsing Regeneron and Roche’s antibody cocktail for COVID patients, the World Health Organization also requests that the companies offer the treatment at a discount, distribute it equitably and release patents to enable better access. read more By Dave Muoio Reports are trickling out on firings and voluntary resignations as some provider organizations reach their first deadlines for partial or full COVID-19 vaccination for their workers. read more By Kyle LaHucik Carolin Barth, M.D., left a 17-year run at Novartis, most recently leading commercial and pipeline strategy for cell and gene therapies, to be the CEO of MiroBio. Novartis also lost Chief Digital Officer Bertrand Bodson, who left earlier this year to be CEO of video game creative services provider Keywords Studios. And Aerie Pharmaceuticals CEO Vicente Anido departed the company days after dismissing the importance of a midphase flop. read more By Angus Liu AstraZeneca and Daiichi Sankyo's Enhertu blows Roche's Kadcyla out of the water in breast cancer. Biogen and Samsung Bioepis win the FDA's first nod for a biosimilar against Lucentis. Clover Biopharmaceuticals' COVID-19 vaccine shows strong efficacy against the delta variant. And more. read more |  | Download the AppNote to learn about Thermo Fisher Scientific’s GMP-compliant, semiautomated manufacturing platform, which when used with Gibco CTS reagents, protocols, and analytics can result in consistent, efficacious CAR T cell production. Download Now. |
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: Patheon by Thermo Fisher Scientific Choose the right AAV platform for your viral vector-based therapy Sponsored by: XIFIN inc. Download the Value of Precision Medicine Informatics (PMI) Initiatives report to learn about the technology, data types, and the value derived from more than 100 PMI initiatives. Sponsored by: EVERSANA Today’s economics do not allow manufactures to keep making decisions in an antiquated way. They need to challenge tradition & deliver faster, cheaper, successful launches. Learn how. Sponsored by: Thermo Fisher Scientific Thermo Fisher Scientific introduces a new NK cell culture medium designed to support feeder-free, high-yield growth for cell therapy applications. Sponsored by: Cascade Chemistry by Aceto Read four customer success stories and four success factors that helped move pharmaceutical customers of Cascade Chemistry by Aceto quickly and effectively to clinic with trial-ready APIs. 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: 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. | 
