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Protaryx Medical Secures FDA Clearance for its Transseptal Access Device
Shots: The US FDA has granted 510(k) clearance to the Transseptal Puncture Device to advance minimally invasive access for left-heart procedures, with plans to begin US commercialization  The Device is a next-gen system enabling zero-exchange access to the left heart, integrating RF guidewire tech with standard electrosurgical generators & an echogenic, extendable atraumatic probe to…
April 14, 2026
Telix Partners with Regeneron to Develop and Commercialize Radiopharmaceutical Therapies for Pain in a ~$2.1B
Shots: Telix and Regeneron have entered into a collaboration to jointly develop and commercialize next-generation radiopharmaceutical therapies Telix will receive a $40M upfront from Regeneron for four initial programs, with options to expand. The companies will share commercialization costs and profits, while Telix may opt to earn up to $535M per program in development and…
April 13, 2026
Haisco Partners with AbbVie to Develop Novel Medicines for Pain in a ~$745M Deal
Shots: Haisco Pharma entered an exclusive licensing deal with AbbVie, granting later global rights (ex-China, Hong Kong & Macau) to develop, manufacture & commercialize novel pain therapies As per the deal, Haisco will receive $30M upfront, with the potential to receive up to $715M in development, regulatory, and commercial milestones, along with tiered royalties on future…
April 13, 2026
BioNTech Reports Positive P-II Data of Trastuzumab Pamirtecan in HER2-Expressing Endometrial Cancer
Shots: BioNTech reported positive results from a P-II study cohort of trastuzumab pamirtecan (BNT323/DB-1303) in HER2-expressing recurrent endometrial cancer, meeting its 1EP of ORR The study cohort (n=145) demonstrated a confirmed ORR of 47.9% (n=96; central testing) and 49.3% in pts. (n=73) previously treated with checkpoint inhibitors, with a mPFS of 8.1mos., showing consistent efficacy…
April 13, 2026
Miracell Reports US FDA 510(k) Clearance for SMART M-CELL PRP and Bone Marrow Concentration Systems
Shots: The US FDA has granted 510(k) clearance to Miracell’s SMART M-CELL PRP Concentration System and Bone Marrow Concentration System, including associated blood and bone marrow kits Clearance was based on substantial equivalence to SmartPReP, with the system demonstrating high cell viability, efficient growth factor extraction, and integrated performance across centrifuge and kit components SMART…
April 13, 2026
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