NEWS

Lupin Receive the CHMP Positive Opinion for Ranluspec (Biosimilar, Lucentis)

Shots: The CHMP has recommended marketing authorization for Lupin’s Ranluspec, in both vial and PFS forms, a biosimilar version of Lucentis (ranibizumab) Opinion was supported by analytical similarity data and a global P-III trial (n=600 pts) in neovascular AMD across the US, EU, Russia, and India Under the agreement, Lupin’s biosimilar ranibizumab will be marketed by Sandoz across the EU (excluding Germany),…

December 17, 2025

Aptar Reports the US FDA Approval of Cardamyst (Etripamil) for PSVT

Shots: The US FDA has approved Aptar’s Cardamyst (Etripamil), developed by Milestone Pharmaceuticals, for the conversion of acute symptomatic episodes of paroxysmal supraventricular tachycardia (PSVT) to sinus rhythm in adults Cardamyst (Intranasal) is a Bidose (BDS) Liquid Nasal Spray System Aptar collaborated with Milestone Pharmaceuticals to design a custom polypropylene container closure system with an…

December 17, 2025

GeneScience Pharmaceutical Inks ~$1.3B Deal with Yarrow Bioscience for GS-098

Shots: GeneScience has entered into an exclusive global ex-China license agreement with Yarrow, backed by RTW Investments, for GS-098 (YB-101 outside of China) to treat Graves’ disease (GD) & thyroid eye disease (TED) As per the deal, Yarrow will obtain exclusive global ex-China rights to develop, manufacture, & commercialize GS-098 for GD & TED,…

December 17, 2025

Harbour BioMed and BMS Collaborate in ~$1.1B Deal to Advance Next-Generation Multi-Specific Antibodies

Shots: Harbour BioMed has entered into a multi-year, global strategic collaboration & license agreement with BMS to discover & develop next-generation multi-specific antibodies leveraging the Harbour Mice platform As per the deal, Harbour BioMed & BMS will jointly identify & advance multi-specific antibody programs, with Harbour eligible for $90M in total payments, ~$1.03B in development & commercial…

December 17, 2025

GSK Reports the FDA Approval of Exdensur (Depemokimab-ulaa) for Asthma with Eosinophilic Phenotype

Shots: FDA has approved GSK’s Exdensur as an add-on maintenance therapy for asthma pts (≥12yrs.) with an eosinophilic phenotype following MHRA’s approval for both asthma & CRSwNP; regulatory review is ongoing in EU, Japan & China Approval was based on the P-III trials: SWIFT-1 (n=382) & SWIFT-2 (n=380) assessing Exdensur vs PBO, both in addition to SoC,…

December 17, 2025

InnoCare Pharma Reports P-IIb Study Findings of Orelabrutinib for Systemic Lupus Erythematosus (SLE)

Shots: Innocare has reported P-IIb trial data assessing orelabrutinib (50 or 75mg, QD, PO) vs PBO in 187 SLE pts for 48wks. & NMPA approval to initiate P-III trial Trial met its 1EP, with 75mg achieving a significantly higher SRI-4 response at Wk. 48 vs PBO (57.1% vs 34.4%) & showing dose-dependent efficacy over 50mg; 75mg…

December 16, 2025

AstraZeneca Reports EC Approval of Saphnelo for Systemic Lupus Erythematosus (SLE)

Shots: The EC has approved AstraZeneca’s Saphnelo (anifrolumab; 120mg, SC, QW, PFS) for the treatment of adults with SLE in combination with SoC; regulatory review is ongoing in the US & Japan Approval was based on the P-III (TULIP-SC) trial assessing Saphnelo vs PBO in 367 pts (18-70yrs.) with mod. to sev. active, autoantibody-positive SLE while receiving SoC,…

December 16, 2025

Dren Bio and Sanofi Forge ~$1.8B Deal to Advance Next-Generation B-Cell Depletion Therapy

Shots: Dren Bio has partnered with Sanofi to discover & develop next-generation B-cell depleting therapy for the treatment of various autoimmune diseases As per the deal, Dren Bio will receive $100M upfront & ~$1.7B in milestones, with both parties jointly leading discovery & preclinical work using Dren Bio’s platform, after which Sanofi will handle…

December 16, 2025

Vanda Pharmaceuticals Seeks FDA Approval for Imsidolimab to Treat Generalized Pustular Psoriasis (GPP)

Shots: The FDA has received Vanda’s BLA for imsidolimab to treat GPP, with a priority review requested that could enable potential approval as early as mid-2026 BLA was supported by global P-III (GEMINI-1 & 2) trials, where GEMINI-1 (n=45) evaluated a single IV dose of imsidolimab (300 or 750mg) vs PBO, & GEMINI-2 re-randomized pts…

December 16, 2025

Adaptive Biotechnologies and Pfizer Sign Rheumatoid Arthritis TCR Target Discovery and Immune Data Licensing Deals

Shots: Adaptive has entered into 2 non-exclusive agreements with Pfizer, combining its T-cell receptor (TCR) discovery & immune receptor antigen-mapping platform to support Pfizer’s research across autoimmune & other disease areas As per the target discovery deal, Adaptive will identify disease-specific TCR targets in rheumatoid arthritis from Pfizer clinical samples, while Pfizer will lead development…

December 16, 2025

NEWS

Lupin Receive the CHMP Positive Opinion for Ranluspec (Biosimilar, Lucentis)

Aptar Reports the US FDA Approval of Cardamyst (Etripamil) for PSVT

GeneScience Pharmaceutical Inks ~$1.3B Deal with Yarrow Bioscience for GS-098

Harbour BioMed and BMS Collaborate in ~$1.1B Deal to Advance Next-Generation Multi-Specific Antibodies

GSK Reports the FDA Approval of Exdensur (Depemokimab-ulaa) for Asthma with Eosinophilic Phenotype

InnoCare Pharma Reports P-IIb Study Findings of Orelabrutinib for Systemic Lupus Erythematosus (SLE)

AstraZeneca Reports EC Approval of Saphnelo for Systemic Lupus Erythematosus (SLE)

Dren Bio and Sanofi Forge ~$1.8B Deal to Advance Next-Generation B-Cell Depletion Therapy

Vanda Pharmaceuticals Seeks FDA Approval for Imsidolimab to Treat Generalized Pustular Psoriasis (GPP)

Adaptive Biotechnologies and Pfizer Sign Rheumatoid Arthritis TCR Target Discovery and Immune Data Licensing Deals

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