NEWS

Bio-Thera Solutions Secures the CHMP’s Positive Opinion for Usymro (Biosimilar, Stelara)

Shots: The CHMP has recommended Usymro (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference product Opinion was based on comprehensive analytical, non-clinical, & clinical data incl. extensive analytical characterization, P-I trial in healthy subjects & P-III trial in mod. to sev. plaque PsO pts, showing similar efficacy, safety, PK &…

June 23, 2025

Madrigal Pharmaceuticals’ Rezdiffra Receives the CHMP’s Positive Opinion for MASH with Liver Fibrosis

Shots: The CHMP has recommended Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic MASH with mod. to advanced liver fibrosis; the EC’s decision is expected by Aug 2025 Opinion was based on P-III (MAESTRO-NASH) trial assessing Rezdiffra (100 & 80mg, PO, QD) vs PBO in MASH pts, which met its 1EPs of fibrosis improvement…

June 23, 2025

Dizal Reports Enrollment Completion in P-III (WU-KONG28) Trial of Sunvozertinib for EGFRm NSCLC

Shots: Dizal has completed pts enrollment in P-III (WU-KONG28) trial of sunvozertinib as a 1L treatment of NSCLC harboring EGFR exon 20 insertion mutations (exon20ins); NDA under the US FDA’s priority review (PDUFA: Jul 7, 2025) Trial assessed sunvozertinib vs Pt-based doublet CTs in treatment-naïve NSCLC pts with EGFR exon20ins across 16 countries & regions…

June 20, 2025

GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: Japan’s MHLW has accepted sNDA of Arexvy RSV vaccine for adults aged 18-49yrs. at increased risk, expanding its use beyond those aged ≥50yrs. Submission was based on P-IIIb trial (n=1458) assessing non-inferiority & safety of Arexvy RSV vaccine in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429); an additional cohort (18-49yrs.; n=603) was followed for…

June 20, 2025

Regeneron and Sanofi Receive the US FDA’s Approval for Dupixent to Treat Bullous Pemphigoid

Shots: The US FDA has approved Dupixent to treat adults with bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks.; regulatory review is ongoing in the EU, Japan, & China Pts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks.…

June 20, 2025

Partner Therapeutics Reports CHMP’s Positive Opinion for Imreplys to Treat Exposure to Myelosuppressive Doses of Radiation

Shots: The CHMP has recommended Imreplys (sargramostim) to treat pts of all ages with Haematopoietic Sub-syndrome of Acute Radiation Syndrome (H-ARS) following myelosuppressive radiation exposure, across the EU, Norway, Iceland, and Liechtenstein Sargramostim is a recombinant human GM-CSF produced using yeast (S. cerevisiae) expression technology In 2018, the same formulation was approved by the US…

June 20, 2025

ExCellThera Reports CHMP’s Positive Opinion for Zemcelpro to Treat Haematological Malignancies

Shots: The CHMP has recommended conditional approval of Zemcelpro in 30 EEA states for adults with haematological malignancies requiring allogeneic HSCT after myeloablative conditioning with no suitable donor; EC’s decision is expected within 2mos. Zemcelpro (UM171 Cell Therapy) was evaluated in P-II trials for pts with high & very high-risk acute leukemias & myelodysplasias with…

June 20, 2025

Johnson & Johnson MedTech Reports the US Launch of VOLT Wrist and Proximal Humerus Plating Systems

Shots: J&J MedTech has launched Variable Angle Optimized Locking Technology (VOLT) Distal Radius (Wrist) & VOLT Proximal Humerus 3.5 Plating System in the US VOLT Wrist, developed with the AO Technical Commission, features the VOLT Two-Column Distal Radius Rim Plate with a new shape that sits more distal to target fragments & is less prominent…

June 20, 2025

ELIAS Animal Health Reports Interim Study Data of ELIAS Cancer Immunotherapy (ECI) in Canine Osteosarcoma

Shots: ELIAS Animal Health has reported interim data from an ongoing study of ELIAS Cancer Immunotherapy (ECI) + CT in dog with osteosarcoma Trial assessed carboplatin (single dose) followed by ECI after 21 days (n=14) vs carboplatin alone (4 doses; n=14), showing 1yr. survival rates of 71% vs 21%; data was presented at ACVIM Forum…

June 20, 2025

Merck and Daiichi Sankyo Report First Patient Dosing with Ifinatamab DXd in P-III (IDeate-Prostate01) Trial for mCRPC

Shots: Merck & Daiichi Sankyo have dosed first pts with ifinatamab deruxtecan (I-DXd) in its P-III (IDeate-Prostate01) trial for metastatic castration-resistant prostate cancer (mCRPC), which was initiated based on positive P-I/II (IDeate-PanTumor01) trial data The P-III (IDeate-Prostate01) trial will evaluate I-DXd (12mg/kg) vs docetaxel (75mg/m²) plus corticosteroid in ~1440 mCRPC pts, who progressed during or after…

June 19, 2025

NEWS

Bio-Thera Solutions Secures the CHMP’s Positive Opinion for Usymro (Biosimilar, Stelara)

Madrigal Pharmaceuticals’ Rezdiffra Receives the CHMP’s Positive Opinion for MASH with Liver Fibrosis

Dizal Reports Enrollment Completion in P-III (WU-KONG28) Trial of Sunvozertinib for EGFRm NSCLC

GSK Reports the MHLW’s sNDA Acceptance of Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Regeneron and Sanofi Receive the US FDA’s Approval for Dupixent to Treat Bullous Pemphigoid

Partner Therapeutics Reports CHMP’s Positive Opinion for Imreplys to Treat Exposure to Myelosuppressive Doses of Radiation

ExCellThera Reports CHMP’s Positive Opinion for Zemcelpro to Treat Haematological Malignancies

Johnson & Johnson MedTech Reports the US Launch of VOLT Wrist and Proximal Humerus Plating Systems

ELIAS Animal Health Reports Interim Study Data of ELIAS Cancer Immunotherapy (ECI) in Canine Osteosarcoma

Merck and Daiichi Sankyo Report First Patient Dosing with Ifinatamab DXd in P-III (IDeate-Prostate01) Trial for mCRPC

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