Featured Story By Amirah Al Idrus Protagonist Therapeutics’ treatment for a rare, slow-growing blood cancer is under an FDA clinical hold after the company reported safety concerns in a nonclinical mouse study. The mice in the study developed benign and malignant skin tumors, the company announced in a statement on Friday. read more |
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Top Stories By Ben Adams AstraZeneca is following suit of many other pharmas and tapping academic and cancer organizations to fill out its oncology research team. read more By Nick Paul Taylor Novartis is building the case for its radioligand therapy. With positive phase 3 primary endpoint data in the bag, Novartis arrived at the European Society of Medical Oncology Congress 2021 armed with evidence of the therapy’s effect on quality of life and pain. read more Sponsored by: IQVIA Are you using data and analytics to design smarter campaigns and more effective sales rep deployment? read more By Kyle LaHucik Elevian has picked up another $40 million to bankroll its work in age-related diseases. The funding will bankroll phase 1 trials, slated for 2023, testing its lead program for stroke recovery. read more By Ben Adams Daiichi Sankyo has seen some great successes in the clinic, the deal room and commercially when it comes to antibody-drug conjugates, but it’s not resting on its laurels. read more By Kyle LaHucik Everest Medicines bought into the COVID-19 vaccine and mRNA space earlier this week, and, now, the biopharma is paying up to $561 million to reach the summit in renal disease treatments. read more By Kyle LaHucik Sparsentan has gone through the wringer in recent months after the FDA denied an accelerated approval in May. Now, just one week after a successful meeting with the regulatory agency, Travere has a licensing agreement with Vifor Pharma that includes $55 million upfront and up to $135 million in biobucks. read more By Emmy Lucas Pfizer darling Pyxis Oncology will advance its lineup of oncology antibody-drug conjugates with the help of a newly-appointed chief medical officer. read more By Annalee Armstrong A CRISPR-Cas9 gene editing technology that has shown promise in clearing HIV from mice is headed into human testing. Excision BioTherapeutics will usher the CRISPR-based therapy EBT-101 into clinical trials after the FDA cleared an investigational new drug application. read more By Andrea Park The first two witnesses took the stand this week in former Theranos CEO Elizabeth Holmes’ federal fraud trial, both former employees of the disgraced blood-testing startup who mapped out the corners they say were regularly cut in the lab, the boardroom and beyond. read more By Arlene Weintraub A study out of Howard Hughes Medical Institute found that more than 100 mutated cancer-suppressor genes don’t act directly on cancer cells to cause them to grow, but rather block the immune system from recognizing and destroying tumors. They believe further research into those immune pathways could inspire new treatments. read more By Angus Liu Takeda snagged an FDA nod for a niche lung cancer med to challenge Johnson & Johnson's bispecific antibody. The FDA slapped another clinical hold on Astellas' gene therapy trial after a patient death. China's Everest Medicines bought its way into the mRNA sector. And more. read more By Kyle LaHucik After pivoting to immunology, AltruBio picked up a new chief medical officer from Sublimity Therapeutics who also held director-level roles at Ardea and Amgen. Rusty Williams is back from Prime time, this time leading Walking Fish Therapeutics as CEO. And ViaCyte filled its vacant chief scientific officer role with an academic. read more | The life-changing potential of cell & gene therapy demands lab services that are just as transformative. LabConnect® leads the evolution of lab services with customized solutions that simplify clinical trial complexity. Let us help with your next study so you can focus on the research. Learn 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: 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: ConnectiveRx Topple barriers to getting patients started on therapy. Guide them with mobile. 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. |