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Velavigo
NEWS

Ollin Biosciences Signs a ~$440M Licensing Agreement with VelaVigo Bio for VBS-102

Shots: VelaVigo Bio has granted Ollin Biosciences an exclusive license to develop, manufacture & commercialize VBS-102 worldwide, except Greater China, where VelaVigo will maintain its rights As per the deal, VelaVigo will receive an upfront payment along with development, regulatory, & commercial milestones in cash & equity, making an aggregate of ~$440M, plus tiered royalties…
April 21, 2025

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Akesobio
NEWS

China’s NMPA Approves Akeso’s Ebdarokimab (IL-12/IL-23 Dual-Targeted mAb) for Moderate to Severe Plaque Psoriasis

Shots: Akeso’s ebdarokimab has received NMPA approval for the treatment of moderate-to-severe plaque psoriasis in adult Clinical study showed strong efficacy and safety of ebdarokimab (135mg) two doses at weeks 0 and 4, with a PASI 75 response rate of 79.4% at 16wks. and ebdarokimab Q12W 77.9% at 52wks. along with significant improvements in patients'…
April 18, 2025

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Regeneron New
NEWS

The US FDA Accepts sBLA Priority Review for Regeneron’s EYLEA HD in Macular Edema Following RVO and Monthly Dosing In Approved Indications

Shots: Regeneron reported the US FDA acceptance for its priority review of the sBLA by using priority review voucher for EYLEA HD (aflibercept 8 mg) to treat macular edema from retinal vein occlusion (RVO) and to expand dosing to include monthly administration in all approved indications. The US FDA’s expected action date is Aug 19,…
April 18, 2025

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Sanofi
NEWS

Sanofi Enters a ~$1.84B Global License Agreement with Earendil Labs for HXN-1002 & HXN-1003

Shots: Earendil Labs has granted Sanofi exclusive global rights to develop HXN-1002 & HXN-1003 bispecific antibodies for autoimmune & inflammatory bowel diseases As per the deal, Earendil Labs will receive $125M upfront, ~$1.72B in development & commercial milestones, incl. a near-term $50M payment, & tiered royalties ranging from high-single to low-double digits Developed using Earendil…
April 17, 2025

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Innocare Pharma
NEWS

InnoCare Pharma Reports NMPA’s NDA Acceptance of Zurletrectinib to Treat NTRK Fusion-Positive Solid Tumors

Shots: China’s NMPA has accepted NDA of zurletrectinib (ICP-723) for the treatment of pts (≥12yrs.) with advanced solid tumors having NTRK gene fusions In a registrational trial, zurletrectinib demonstrated favorable safety & strong efficacy, with the ability to overcome acquired resistance to the 1st generation TRK inhibitors in mentioned pts Zurletrectinib is a next-generation pan-TRK inhibitor…
April 17, 2025

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Briacell
NEWS

BriaCell Reveals P-II Trial Data of Bria-IMT Regimen for Metastatic Breast Cancer

Shots: BriaCell has reported P-II trial data comparing Bria-IMT + check point inhibitors (CPI) to Trodelvy's historical data in heavily pre-treated pts (n=54) with late-stage metastatic breast cancer 37 HR+ breast cancer pts of P-II trial were treated with the ongoing pivotal P-III (BRIA-ABC) trial formulation of Bria-IMT, showing favorable survival data Trial showed 25/37…
April 17, 2025

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Ceribell
NEWS

Ceribell’s Clarity Algorithm Receives the US FDA’s 510(k) Clearance to Detect Electrographic Seizures in Pediatric Patients

Shots: The US FDA has granted 510(k) clearance to Clarity algorithm for the detection of electrographic seizures in pts (≥1yrs.) Pediatric clearance was backed by extensive electroencephalography (EEG) dataset developed from ~1,700 pts to detect non-convulsive seizures, ensuring rapid diagnosis & prevention of serious brain injury Clarity algorithm allows seizure detection in both pediatric &…
April 17, 2025

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