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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…
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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…
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The biopharma industry is a multi-hundred-billion-dollar market, with a projected compound annual growth rate (CAGR) of 8.6%, the global biopharma market is expected to reach $1.41T by 2034. Eli Lilly and Co. ranked first with $65.17B, followed by Pfizer ($61.19B) and AbbVie ($61.16B), reflecting strong market concentration among large-cap innovators with diversified, high-value portfolios …
Oxford BioTherapeutics Partners with BMS to Develop Next-Generation T-cell Engagers for Solid Tumors
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Oxford BioTherapeutics has entered into a multi-year strategic collaboration with Bristol Myers Squibb (BMS) to discover and develop next-generation T-cell engager therapies targeting solid tumors
Under the agreement, OBT will leverage its OGAP-Verify platform to identify tumor-selective targets and design & delivery of developed candidates, while Bristol Myers Squibb will lead subsequent clinical research,…
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China’s National Medical Products Administration has accepted the BLA for DualityBio’s trastuzumab pamirtecan (T-Pam; DB-1303/BNT323), an investigational ADC, for the second-line treatment of unresectable or metastatic HER2+ breast cancer
The application is supported by interim results from the pivotal P-III (DB-1303-O-3001) trial, which met its primary endpoint, demonstrating statistically significant improvement in PFS vs…
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Health Canada has approved Empaveli (pegcetacoplan) for patients (≥12yrs.) with C3 glomerulopathy (C3G) or primary IC-MPGN to reduce proteinuria, marking the first approved therapy for these indications in Canada
Approval was based on the P-III (VALIANT) study, where Empaveli demonstrated a 68% reduction in proteinuria (uPCR), stabilization of kidney function, and clearance of C3…
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The US FDA has accepted the resubmitted NDA for TLX101-Px (Pixclara; 18F-FET), an investigational PET imaging agent for the detection and characterization of glioma in adult and pediatric patients
The US FDA has assigned a PDUFA date of 11’Sep, 2026; TLX101-Px has received Orphan Drug and Fast Track designations, addressing unmet needs in distinguishing…
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Gilead Sciences has exercised its option to exclusively license KT-200, a first-in-class oral CDK2 molecular glue degrader, from Kymera Therapeutics under their existing collaboration
The option exercise triggers a $45M milestone payment to Kymera; the company remains eligible for up to $750M in total payments, including milestones and tiered royalties on net sales
Gilead…
Imagene AI has entered into a collaboration with Daiichi Sankyo to advance biomarker discovery and response prediction across oncology drug development programs
Under the collaboration, Daiichi Sankyo will leverage Imagene’s OI Suite, powered by the CanvOI foundation model, to integrate H&E and IHC whole-slide images with molecular and clinical data to enhance biomarker identification and…
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The Healthcare IPOs in 2025 underscore sustained investor confidence across biotech, medtech, digital health, and AI-enabled healthcare companies, signaling robust capital deployment into next-generation therapies, advanced diagnostics, and evolving healthcare delivery models worldwide.
IPO activity was dominated by high-value raises, with Medline Industries ($7.2B) leading by a wide margin, followed by Caris Life Sciences…

