HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Fanregratinib for Intrahepatic Cholangiocarcinoma (ICC)

Shots: The Chinese NMPA has accepted NDA & granted priority review to fanregratinib (HMPL-453) for the treatment of adults with advanced, metastatic, or unresectable ICC with FGFR 2 fusion/rearrangement who have previously received systemic therapy NDA was supported by the P-II trial in China, which met its 1EP of improved ORR, with 2EPs findings, …

ByRidhi RastogiDecember 29, 2025

NEWS

Transcenta and EirGenix Collaborate to Advance Integrated Continuous Biomanufacturing Technologies

Shots: EirGenix has entered into a strategic collaboration and non-exclusive licensing agreement with Transcenta for its Highly Intensified Continuous Bioprocessing (HiCB) platform Under the agreement, Transcenta will grant EirGenix a non-exclusive license to its HiCB platform, incl. continuous perfusion & integrated hybrid continuous purification process technologies, as well as documentation, know-how & regulatory support to…

ByRidhi RastogiDecember 29, 2025

NEWS

CARsgen Reports the NMPA’s Dual IND Application Submission for CT0596 to Initiate P-Ib/II Trials in R/R MM and pPCL

Shots: Chinese NMPA received two IND applications for CT0596 to initiate P-Ib/II trials in r/r multiple myeloma (MM) & primary plasma cell leukemia (pPCL), respectively IIT in China showed favorable efficacy as of Aug 31, 2025, with 6/8 evaluable R/R MM pts achieving PR or better (3 CR/sCR, 1 VGPR, 2 PR) at an mFU…

ByRidhi RastogiDecember 29, 2025

NEWS

Harbour BioMed Collaborates with Yantai Lannacheng Biotechnology to Develop Radionuclide Drug Conjugates (RDCs)

Shots: Harbour BioMed has entered into a long-term strategic collaboration with Yantai Lannacheng Biotechnology to jointly advance the development of next-generation RDCs Collaboration will combine Harbour’s fully human antibody discovery capabilities via its Harbour Mice platform with Lannacheng’s radiopharmaceutical R&D & commercialization strengths Harbour Mice platform provides fully human mAbs in both conventional & heavy chain-only…

ByRidhi RastogiDecember 29, 2025

NEWS

ABL Bio Secures Upfront Payment and Equity Investment from Lilly to Accelerate Grabody Programs

Shots: ABL Bio has secured a total of $55M, incl. $40M upfront & $15M in equity investment, from Eli Lilly under their ~$2.602B license, research & collaboration agreement Under the deal, ABL Bio & Eli Lilly are jointly advancing multiple therapeutic candidates across diverse modalities, leveraging ABL Bio’s Grabody platform for collaborative research & development…

ByRidhi RastogiDecember 29, 2025

NEWS

Bruno Vision Care Reports the US FDA Clearance of Deseyne for Presbyopia

Shots: FDA has cleared Deseyne, a daily disposable soft contact lens for presbyopia that uses patented Extended Depth of Focus technology Deseyne provides continuous near, intermediate, & distance vision through Cataltheia’s patented hyper-refractive central zone, showing a clinical advantage over multifocal lenses with minimal patient adaptation, strong comfort, & no adverse events reported in studies Made…

ByRidhi RastogiDecember 26, 2025

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Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD

Shots: The US FDA has granted IND clearance to initiate a P-IIa trial of 9MW1911 for the treatment of patients with mod. to sev. chronic obstructive pulmonary disease (COPD) In the China P-IIa trial (n=80) vs PBO, 9MW1911 showed dose-proportional exposure & dose-dependent efficacy, with the RP2D (n=30) reducing mod. to sev. COPD exacerbations by…

ByRidhi RastogiDecember 26, 2025

NEWS

Sanofi and Regeneron’s Dupixent (Dupilumab) Receives MHLW Approval for Children with Bronchial Asthma

Shots: The MHLW has approved Sanofi and Regeneron’s Dupixent for the treatment of bronchial asthma in children (6-11yrs.) with severe or refractory disease whose symptoms are inadequately controlled with existing therapy Approval was based on the P-III (VOYAGE) trial data in the overall population & those with a type 2 inflammation phenotype, which showed reduced…

ByRidhi RastogiDecember 26, 2025

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Italfarmaco and JCR Pharmaceuticals Partner to Commercialize Givinostat in Japan

Shots: Italfarmaco has entered into an exclusive licensing agreement with JCR Pharmaceuticals for the development and commercialisation of givinostat in Japan As per the deal, JCR will secure exclusive rights to commercialize givinostat, marketed as Duvyzat in US, EU & UK, for Duchenne muscular dystrophy (DMD) in Japan & will lead local execution of clinical…

ByRidhi RastogiDecember 26, 2025

NEWS

Omeros Receives the FDA Approval for Yartemlea (Narsoplimab-wuug) to Treat TA-TMA

Shots: The US FDA has approved Yartemlea for the treatment of HSCT-Associated Thrombotic Microangiopathy, with US launch planned for Jan 2026. MAA is under the EMA’s review, with a decision expected in mid-2026 Approval was based on the TA-TMA Study (n=28) plus EAP (N=221 adults & pediatric pts), where 19 pts (13 adult & 6…

ByRidhi RastogiDecember 26, 2025

Ridhi Rastogi

HUTCHMED Reports NMPA’s NDA Acceptance with Priority Review of Fanregratinib for Intrahepatic Cholangiocarcinoma (ICC)

Transcenta and EirGenix Collaborate to Advance Integrated Continuous Biomanufacturing Technologies

CARsgen Reports the NMPA’s Dual IND Application Submission for CT0596 to Initiate P-Ib/II Trials in R/R MM and pPCL

Harbour BioMed Collaborates with Yantai Lannacheng Biotechnology to Develop Radionuclide Drug Conjugates (RDCs)

ABL Bio Secures Upfront Payment and Equity Investment from Lilly to Accelerate Grabody Programs

Bruno Vision Care Reports the US FDA Clearance of Deseyne for Presbyopia

Mabwell Receives the US FDA IND Clearance to Initiate P-IIa Trial of 9MW1911 in COPD

Sanofi and Regeneron’s Dupixent (Dupilumab) Receives MHLW Approval for Children with Bronchial Asthma

Italfarmaco and JCR Pharmaceuticals Partner to Commercialize Givinostat in Japan

Omeros Receives the FDA Approval for Yartemlea (Narsoplimab-wuug) to Treat TA-TMA

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