NEWS

Incyte Partners with Genesis to Develop and Commercialize Novel Small Molecules Using Genesis’ GEMS AI Platform

Shots: Incyte has partnered with Genesis to advance research, discovery, & development of novel small molecules using GEMS (Genesis Exploration of Molecular Space) AI platform, initially focusing on targets selected by Incyte As per the agreement, Incyte will gain exclusive rights to develop & commercialize products arising from this deal in exchange for $30M…

February 21, 2025

GSK Reports the China’s NMPA Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD

Shots: China’s NMPA has accepted the NDA for Nucala as an add-on treatment for COPD with eosinophilic phenotype based on P-III (MATINEE) study; global regulatory filings is ongoing The MATINEE study assessing Nucala (100mg, Q4W, SC) vs PBO in addition to inhaled triple therapy in COPD pts (n=804) with type 2 inflammation achieved its 1EP, showing…

February 20, 2025

Harbour BioMed Enters into a Collaboration with Insilico Medicine to Advance AI-Driven Antibody Discovery and Development

Shots: Harbour BioMed has entered into a strategic collaboration with Insilico Medicine to accelerate therapeutic antibody development, combining their expertise in antibody discovery and artificial intelligence The companies will also collaborate on early-stage drug discovery targeting novel antibodies, leveraging Insilico's AI expertise and Harbour BioMed's wet lab capabilities for immunology, oncology, and neuroscience, aiming…

February 20, 2025

Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

Shots: The US FDA has accepted the BLA of AVT06 (2mg) for treating eye disorders, including diseases that can lead to vision loss or blindness. The regulatory approval process is expected to finish in Q4’25 AVT06/AVT29 is a recombinant fusion protein and biosimilar candidate to Eylea (aflibercept), targeting VEGF to inhibit receptor activation, neovascularization,…

February 20, 2025

The US FDA Accepts NDA of Boehringer Ingelheim’s Zongertinib for HER2 (ERBB2)-Mutant NSCLC

Shots: The US FDA has accepted & granted priority review to the NDA of zongertinib (BI 1810631) for the treatment of pts with inoperable or metastatic NSCLC harboring HER2 (ERBB2) mutations who have received prior systemic therapy (PDUFA: Q3’25) Submission was based on P-Ib (Beamion LUNG-1) trial assessing zongertinib as Monotx. in 2 arms…

February 20, 2025

CSPC Pharmaceutical Collaborates with Radiance Biopharma to Develop and Commercialize RB-164 (SYS6005) as an Anti-Cancer Therapy

Shots: CSPC has granted Radiance exclusive rights to develop & market RB-164 in the US, Canada, EU, UK, Switzerland, Norway, Iceland, Liechtenstein, Albania, Montenegro, North Macedonia, Serbia, & Australia, while retaining rights to other markets As per the deal, CSPC will get $15M upfront, ~$150M in development & regulatory milestones and ~$1B in commercial…

February 20, 2025

Epitopea Partners with Merck to Discover Cryptigen Tumor-Specific Antigens

Shots: Epitopea & Merck have entered into license & research collaboration agreement to discover Cryptigen tumor-specific antigens (TSAs) in an undisclosed solid tumor As per the deal, Epitopea will receive an undisclosed upfront & ~$300M in milestones per product in exchange for Merck receiving exclusive development & commercialization rights to the TSA products identified…

February 20, 2025

BMS Reports P-III (CheckMate-816) Trial Data of Opdivo as a Neoadjuvant Treatment of Resectable NSCLC

Shots: BMS has reported final data from P-III (CheckMate-816) trial of neoadj. Opdivo + Pt-doublet CT to treat adults with operable NSCLC (tumors ≥4cm or node positive) The P-III (CheckMate-816) trial evaluates Opdivo (360mg, Q3W for 3 cycles) + CT vs CT alone in 358 pts with resectable stage IB to IIIA NSCLC regardless…

February 19, 2025

Biogen Collaborates with Stoke Therapeutics to Develop and Commercialize Zorevunersen for Dravet Syndrome

Shots: Biogen & Stoke have partnered to develop & market zorevunersen for Dravet syndrome with Stoke retaining rights in the US, Canada, & Mexico while leading global development & Biogen securing marketing rights in other regions As per the deal, Stoke will get $165M upfront, ~$385M in development & commercial milestones, & net sales-based…

February 19, 2025

Celltrion Secures the EC’s Approval for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

Shots: The EC has approved Eydenzelt (CT-P42, aflibercept), a biosimilar to Eylea, Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products The P-III trial of Eydenzelt (40 mg/mL solution for injection in a vial & pre-filled syringe) vs Eylea (aflibercept) in diabetic macular edema (DME)…

February 19, 2025

NEWS

Incyte Partners with Genesis to Develop and Commercialize Novel Small Molecules Using Genesis’ GEMS AI Platform

GSK Reports the China’s NMPA Acceptance of Nucala (Mepolizumab) as an Add-on Treatment for COPD

Harbour BioMed Enters into a Collaboration with Insilico Medicine to Advance AI-Driven Antibody Discovery and Development

Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US

The US FDA Accepts NDA of Boehringer Ingelheim’s Zongertinib for HER2 (ERBB2)-Mutant NSCLC

CSPC Pharmaceutical Collaborates with Radiance Biopharma to Develop and Commercialize RB-164 (SYS6005) as an Anti-Cancer Therapy

Epitopea Partners with Merck to Discover Cryptigen Tumor-Specific Antigens

BMS Reports P-III (CheckMate-816) Trial Data of Opdivo as a Neoadjuvant Treatment of Resectable NSCLC

Biogen Collaborates with Stoke Therapeutics to Develop and Commercialize Zorevunersen for Dravet Syndrome

Celltrion Secures the EC’s Approval for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva)

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