The potential independent third-party review of prior Phase 3 clinical data sounds great - but given FDA’s past protocol, I fear another trial will be required. Here’s to the best of all possible futures - regardless of the path that leads us there.
Nothing validates more than client testimonials!
See how Poseida Therapeutics, Inc. relies on ActiveDisclosure to use the right rules and templates to comply with new reporting requirements.
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PPMD is excited to learn that Capricor Therapeutics, Inc. has completed the submission of its rolling Biologics License Application (BLA) to the U.S. FDA seeking full approval for deramiocel for the treatment of #Duchenne cardiomyopathy. Learn more: https://lnkd.in/euFhd53V
Thank you, Aayushi Pratap, for featuring Perspective in this C&EN article on the rise of lead isotopes in the radiopharmaceutical industry. Many in the field are recognizing that, in addition to its clinical benefits, lead offers a relatively easier manufacturing process compared to its competitors.
Discover more about the benefits of lead-212 in alpha-particle therapy here: https://bit.ly/4cfRkxB
Have questions about treatment options for glaucoma? We've got answers. The 2024 Glaucoma Pipeline interactive poster, developed under the direction of Arsham Sheybani, MD, and Sahar Bedrood, MD, PhD, offers a view into the various surgical and pharmaceutical options for treating glaucoma as well as those in development. https://bit.ly/491yh9u
25+ year biotech patent attorney and entrepreneur/investor helping biotech companies maximize the value of their IP & find new customers to accelerate innovation (Founder of Double Helix Law and BiopharmIQ.com).
I love to see these bio/pharma therapeutics getting close to the FDA finish line. Of course, they all may not get approved, but it takes huge effort to get to this point.
Interesting group with antibiotics, small molecules, CAR-T cell therapy, and bi-specific antibody therapy.
Let's salute the power of bio/pharma to improve healthcare!
Co-Founder @ BiopharmIQ - Bio/Pharma data for business development and investors. Helping biotech sales/BD teams get high-quality targeted lists of potential partners.
BCBN Feed: Biogen offers to buy Sage Therapeutics for $469M
https://lnkd.in/g4jhuW2k Biogen has made an offer to acquire its partner Sage Therapeutics, according to a Friday evening regulatory disclosure, following months of setbacks by the smaller company that have led to a long slide in its ... ... [...]
In this latest K-Cast series, “Advancing Healthcare With Prescription Drug Therapeutics,” experts offer insights on the future of prescription digital therapeutics (PDTs) and how the landscape might evolve for PDTs over the next 5 years. Watch the series here: https://bit.ly/4dR4oLW#ManagedCare#HealthTechMahsa Salsabili
Join our experts, Mahdi Roohnikan and Sahil Shah, in this upcoming webinar that will uncover key aspects to consider for CMC testing for protein-based therapeutics. Topics will include FDA expectations for NDA submissions, analytical challenges unique to mAB/ADC, techniques utilized for demonstrating product quality attributes, and guidance for a successful CMC testing program.
Register today to save your seat and receive a complimentary recording!
Link: https://bit.ly/4cc59hu#drugdevelopment#biologicstesting#biopharmatesting#SGSNorthAmerica
CEO & Co-Founder at Ketim Technologies | Mum | PPD Survivor | Innovator | Entrepreneur | Neuroscientist | Mental Health Advocate |
5moCongrats! Great to see the continued work in this very needed space!