NEWS

The NMPA Approves Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: The NMPA has approved Merck KGaA's Pimicotinib (PO) for the treatment of adults with symptomatic TGCT, where surgical resection can lead to functional limitation or relatively severe morbidity Approval was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which…

December 23, 2025

Alvotech Reports the European Launch of Gobivaz (Biosimilar, Simponi)

Shots: Alvotech has reported the launch of Gobivaz (AVT05), a biosimilar version of Simponi (golimumab) for the treatment of several chronic inflammatory diseases, with commercialization led by Advanz Pharma In the UK, Gobivaz’s launch is supported by an NHS England tender award, while rollout across EEA markets will advance in line with country-specific pricing, reimbursement…

December 23, 2025

Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINY-Endometrial02) Trial of Enhertu for HER2+ Endometrial Cancer

Shots: Daiichi Sankyo has dosed the first patient with Enhertu ± radiotherapy in the P-III (DESTINY-Endometrial02) trial, conducted in collaboration with The GOG Foundation & ENGOT, with the GINECO as the lead ENGOT group The trial will evaluate the efficacy and safety of Enhertu (5.4mg/kg) ± radiotherapy vs SoC CT (carboplatin & paclitaxel) ± radiotherapy…

December 23, 2025

Samsung Biologics Expands U.S. Manufacturing Footprint with Acquisition of Human Genome Sciences from GSK

Shots: Samsung Biologics’ US subsidiary entered a definitive agreement to acquire 100% of Human Genome Sciences from GSK, securing its first US based manufacturing site in Rockville, Maryland As per the deal terms, Samsung Biologics will acquire the Rockville assets for $280M, with closing expected by end of Q1’26, while retaining 500+ employees to ensure…

December 22, 2025

Jacobio Pharma Forge ~$2B+ Partnership with AstraZeneca for JAB-23E73

Shots: Jacobio Pharma entered a global exclusive licensing agreement with AstraZeneca for JAB-23E73, granting AstraZeneca exclusive development & commercialization rights outside China, while both companies will jointly develop & commercialize in China As per the deal, Jacobio will receive $100M upfront, and is eligible up to $1.91B in development & commercial milestones, and tiered royalties…

December 22, 2025

Johnson & Johnson’s Tremfya (Guselkumab) Receives the EC Approval for Pediatric Plaque Psoriasis (PsO)

Shots: The EC has approved Tremfya (SC) for children (≥6yrs.) with mod. to sev. PsO, who are candidates for systemic therapy Approval was based on P-III (PROTOSTAR) trial in 120 pediatric pts, which met its co-1EPs of PASI 75 (~76% vs 20%) & IGA 0/1 (66% vs 16%) at 16wks., with ~40% vs 4% achieving IGA…

December 22, 2025

Amneal Pharmaceuticals and mAbxience’s Boncresa and Oziltus (Biosimilar, Prolia and Xgeva) Receive the US FDA’s Approval

Shots: The US FDA has approved Boncresa (denosumab-mobz), a biosimilar version of Prolia, and Oziltus (denosumab-mobz), a biosimilar version of Xgeva Denosumab is an mAb that reduces bone resorption and is used in oncology and osteoporosis indications Under the Amneal and mAbxience collaboration, mAbxience manages development and manufacturing, and Amneal has exclusive US commercialization rights Ref: Amneal Pharmaceuticals| Image: Amneal Pharmaceuticals and mAbxience | Press Release Related News:- Kashiv BioSciences and Amneal…

December 22, 2025

Boehringer Ingelheim Receives the US FDA Approval of Jascayd (Nerandomilast) for Progressive Pulmonary Fibrosis

Shots: The US FDA has approved Jascayd for the treatment of adults with progressive pulmonary fibrosis (PPF) Approval was based on the P-III (FIBRONEER-ILD) trial of Jascayd vs PBO, where Jascayd significantly reduced lung function decline at Wk. 52, with FVC decreases of 86mL (18mg) & 69mL (9mg) vs 152mL with PBO, showing clinically meaningful…

December 22, 2025

BioMarin to Acquire Amicus Therapeutics for ~$4.8B

Shots: BioMarin has entered into a definitive agreement to acquire Amicus, strengthening BioMarin's commercial portfolio with Galafold (migalastat) for Fabry Disease & Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) for Pompe Disease As per the deal, BioMarin will acquire Amicus for $14.5/share in an all-cash transaction for a total equity value of ~$4.8B; closing is expected in Q2’26 Amicus also…

December 22, 2025

Cytokinetics Reports the US FDA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

Shots: The US FDA has approved Cytokinetics’ Myqorzo (5, 10, 15 & 20mg) for the treatment of adults with symptomatic oHCM, available in second half of Jan 2026 through a restricted program via REMS Approval was based on P-III (SEQUOIA-HCM) trial of Myqorzo, showing improved exercise capacity vs PBO at 24wks., with increased peak oxygen…

December 22, 2025

The NMPA Approves Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Alvotech Reports the European Launch of Gobivaz (Biosimilar, Simponi)

Daiichi Sankyo Reports First Patient Dosing in P-III (DESTINY-Endometrial02) Trial of Enhertu for HER2+ Endometrial Cancer

Samsung Biologics Expands U.S. Manufacturing Footprint with Acquisition of Human Genome Sciences from GSK

Jacobio Pharma Forge ~$2B+ Partnership with AstraZeneca for JAB-23E73

Johnson & Johnson’s Tremfya (Guselkumab) Receives the EC Approval for Pediatric Plaque Psoriasis (PsO)

Amneal Pharmaceuticals and mAbxience’s Boncresa and Oziltus (Biosimilar, Prolia and Xgeva) Receive the US FDA’s Approval

Boehringer Ingelheim Receives the US FDA Approval of Jascayd (Nerandomilast) for Progressive Pulmonary Fibrosis

BioMarin to Acquire Amicus Therapeutics for ~$4.8B

Cytokinetics Reports the US FDA Approval of Myqorzo (Aficamten) for Obstructive Hypertrophic Cardiomyopathy (oHCM)

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