GSK Receives MHLW Approval for Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The Japanese MHLW has approved GSK's Arexvy RSV vaccine for adults (18-49yrs.) at increased risk for RSV disease, expanding its use beyond those aged ≥50yrs. Approval was based on P-IIIb trial (n=1458) assessing Arexvy in individuals (18-49yrs.; n=426) compared to adults (≥60yrs.; n=429), which showed a non-inferior immune response in individuals (18-49yrs.) who are at increased…

ByRidhi Rastogi1 day ago

NEWS

MEDIPOST Reports P-III Trial Data in Japan for Cartistem in Knee Osteoarthritis

Shots: MEDIPOST has reported the P-III trial data assessing Cartistem (n=59) vs hyaluronic acid (n=61) in 130 knee osteoarthritis pts over a 52wk. follow-up period across 13 Japanese sites Trial met both co-1EPs of WOMAC knee pain & function scores, and ICRS cartilage repair grading. Improvements were also observed across all 2EPs, incl. VAS pain…

ByRidhi RastogiMay 15, 2026

NEWS

Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

Shots: The Japanese MHLW has approved Dupixent to treat adults with mod. to sev.bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks. 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. 4 to 6 if disease control was…

ByRidhi RastogiMarch 25, 2026

NEWS

Cytiva and Yoshindo Collaborate to Strengthen Domestic Biosimilar Manufacturing through their FlexFactory Contract in Japan

Shots: Cytiva and Yoshindo sign a FlexFactory contract to support the establishment of domestic biosimilar drug substance manufacturing in Japan. The investment is partly supported by Japan’s MHLW Yoshindo plans to supply biosimilars from its Toyama plant starting in 2028, supporting a stable and affordable biologics supply in Japan Cytiva’s FlexFactory platform uses modular bioprocessing technologies to support faster transition from facility design to GMP…

ByDipanshu DixitMarch 23, 2026

NEWS

GSK Reports the MHLW’s NDA Acceptance for Bepirovirsen to Treat Chronic Hepatitis B

Shots: The Japanese MHLW has accepted the NDA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB) NDA was supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in pts from 29 countries for the treatment of CHB Trials showed statistically significant &…

ByRidhi RastogiFebruary 27, 2026

NEWS

GSK Reports the MHLW Approval of Exdensur (Depemokimab) for Severe Asthma and CRSwNP

Shots: GSK’s Exdensur was approved for sev. or refractory bronchial asthma unresponsive to existing therapies & for CRSwNP in pts whose disease remains inadequately controlled with SoC, based on the P-III (SWIFT & ANCHOR) trials, respectively; filings under regulatory review in the EU & China SWIFT-1 (n=382) & SWIFT-2 (n=380) trials showed depemokimab reduced asthma…

ByRidhi RastogiJanuary 6, 2026

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

INSIGHTS+

New Drug Designations – November 2025

Shots: PharmaShots’ Designation Report provides a concise overview of the latest drug designations granted by major regulatory authorities, including the FDA, EMA, MHLW, Health Canada, and NMPA  The November 2025 report covers designations granted to 22 drugs and 1 medical device, spanning 8 small molecules, 8 biologics, 2 cell and gene therapies & 1 medical…

ByRidhi RastogiDecember 23, 2025

NEWS

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R Follicular Lymphoma (FL)

Shots: The MHLW has approved Incyte’s Minjuvi + rituximab & lenalidomide for the treatment of adults with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy Approval was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL or r/r nodal, splenic or extranodal MZL…

ByRidhi RastogiDecember 23, 2025

NEWS

Renalys Pharma Reports the Topline P-III Trial Data of Sparsentan for Japanese Patients with IgA Nephropathy

Shots: Renalys Pharma has reported topline P-III trial data assessing sparsentan (RE-021; PO) in Japanese pts with IgA nephropathy, with MHLW’s NDA submission based on trial results planned in 2026 Trial met its 1EP, with a least-squares geometric mean UPCR reduction of 58.54% after 36wks. in Japanese IgAN pts (N=35) & showed favorable safety Additionally,…

ByRidhi RastogiNovember 26, 2025

GSK Receives MHLW Approval for Arexvy to Prevent Respiratory Syncytial Virus (RSV) Disease

MEDIPOST Reports P-III Trial Data in Japan for Cartistem in Knee Osteoarthritis

Regeneron and Sanofi Report MHLW’s Approval of Dupixent to Treat Bullous Pemphigoid

Cytiva and Yoshindo Collaborate to Strengthen Domestic Biosimilar Manufacturing through their FlexFactory Contract in Japan

GSK Reports the MHLW’s NDA Acceptance for Bepirovirsen to Treat Chronic Hepatitis B

GSK Reports the MHLW Approval of Exdensur (Depemokimab) for Severe Asthma and CRSwNP

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

New Drug Designations – November 2025

Incyte’s Minjuvi (Tafasitamab) Combination Gains the MHLW Approval for R/R Follicular Lymphoma (FL)

Renalys Pharma Reports the Topline P-III Trial Data of Sparsentan for Japanese Patients with IgA Nephropathy

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