Sanofi Reports P-III (LEAP2MONO) Trial Data on Venglustat in Type 3 Gaucher Disease

Shots: Sanofi has reported P-III (LEAP2MONO) trial data assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts (≥12yrs.) with GD3 Trial met its 1EP, improving neurological symptoms measured by modified SARA total score & RBANS at Wk. 52, & achieved 3 of 4 key 2EPs, incl. reductions in spleen & liver…

ByRidhi RastogiFebruary 3, 2026

NEWS

Sanofi Receives the CHMP Positive Opinion for Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Shots: The CHMP has recommended Rezurock (200mg) for conditional approval in chronic GVHD pts (≥12yrs., ≥40kg), with EC’s decision expected in the coming wks. Opinion was supported by extensive clinical data, incl. the P-II (ROCKstar) trial, which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic…

ByRidhi RastogiFebruary 2, 2026

TOP 20

Top 20 M&A of 2025 by Total Deal Value

Shots: 2025 pharma M&A was defined by fewer but more transformational deals, with companies prioritizing commercial-stage assets, late-stage pipelines, and platform technologies capable of reshaping long-term growth and strengthening core therapeutic franchises The year’s momentum was led by three standout transactions, J&J’s $14.6B acquisition of Intra-Cellular Therapies, Novartis’ $12B deal for Avidity Biosciences, and Merck’s…

ByPrince GiriJanuary 30, 2026

INSIGHTS+

EMA Marketing Authorization of New Drugs in December 2025

Shots: Innovation in drug development continues to reshape patient care across dermatology, cardiology, immunology, oncology, respiratory medicine, and infectious diseases, as regulatory momentum in Europe remains strong toward the end of 2025. Recent EMA actions highlight how advanced biologics, precision small molecules, and next-generation vaccines are translating clinical breakthroughs into real-world impact. In December 2025, the EMA…

ByDipanshu DixitJanuary 20, 2026

NEWS

Sanofi Secures China Approval for Myqorzo and Redemplo in oHCM and FCS

Shots: China’s NMPA has approved Sanofi-licensed Myqorzo (aficamten) for the treatment of obstructive hypertrophic cardiomyopathy (oHCM) and Redemplo (plozasiran) for triglyceride reduction in adults with familial chylomicronemia syndrome (FCS) on dietary control The approval of Myqorzo was based on the pivotal P-III (SEQUOIA-HCM) study in pts with symptomatic oHCM, while Redemplo’s approval was supported by…

ByDipanshu DixitJanuary 15, 2026

NEWS

Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Shots: The EC has approved Sanofi's Teizeild (Tzield outside the EU) to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the other regions Approval was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32)…

ByRidhi RastogiJanuary 12, 2026

NEWS

Arrowhead Pharmaceuticals Receives the NMPA Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Shots: The Chinese NMPA has approved Redemplo to reduce triglycerides (TGs) in adults with FCS; regulatory review is ongoing in other regions Redemplo will be commercialized by Sanofi in Greater China under an agreement with Arrowhead, with NMPA approval triggering a $10M milestone payment from Sanofi to Arrowhead’s subsidiary Visirna Therapeutics Redemplo is an siRNA…

ByRidhi RastogiJanuary 8, 2026

NEWS

Earendil Labs and Sanofi Forge ~$2.56B Deal to Advance Bispecific Antibodies for Autoimmune Diseases

Shots: Earendil Labs has entered into a strategic collaboration with Sanofi to advance bispecific candidates for autoimmune & inflammatory diseases using Earendil's discovery platform Under the deal, Earendil Labs will identify & optimize bispecific antibody candidates for autoimmune & inflammatory disease targets, while Sanofi will handle the development & worldwide commercialization of the products As…

ByRidhi RastogiJanuary 5, 2026

NEWS

Sanofi Reports the US FDA Priority Review of Tzield to Delay Progression of Type 1 Diabetes in Children (≥1years)

Shots: The US FDA has accepted sBLA & granted priority review to Tzield (teplizumab-mzwv) to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D (PDUFA: Apr 29, 2026) sBLA was supported by an interim 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of…

ByRidhi RastogiJanuary 5, 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

Sanofi Reports P-III (LEAP2MONO) Trial Data on Venglustat in Type 3 Gaucher Disease

Sanofi Receives the CHMP Positive Opinion for Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Top 20 M&A of 2025 by Total Deal Value

EMA Marketing Authorization of New Drugs in December 2025

Sanofi Secures China Approval for Myqorzo and Redemplo in oHCM and FCS

Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Arrowhead Pharmaceuticals Receives the NMPA Approval for Redemplo (Plozasiran) to Treat Familial Chylomicronemia Syndrome (FCS)

Earendil Labs and Sanofi Forge ~$2.56B Deal to Advance Bispecific Antibodies for Autoimmune Diseases

Sanofi Reports the US FDA Priority Review of Tzield to Delay Progression of Type 1 Diabetes in Children (≥1years)

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

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