Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)

Shots: Sanofi has reported the P-III (Baby-COMET) trial results assessing Nexviazyme (avalglucosidase alfa; 40mg/kg, Q2W, IV) in 17 treatment-naïve pediatric pts (≤12mos.) with IOPD Trial met its 1EP, with more treatment-naïve pts (≤6mos.) alive & free of invasive ventilation at 52wks., and achieved all 2EPs, including higher survival without invasive ventilation in pts at 12…

ByRidhi Rastogi1 day ago

NEWS

Sanofi Reports the EC Approval for Cenrifki (Tolebrutinib) to Treat SPMS without Relapses

Shots: The EC has approved Cenrifki (PO, QD) for the treatment of secondary progressive multiple sclerosis (SPMS) without relapses in the last 2yrs. Approval was backed by P-III (HERCULES) trial (vs PBO) in non-relapsing SPMS (nrSPMS) & supporting data from P-III (GEMINI 1 & 2) studies (vs teriflunomide) in relapsing MS, with HERCULES demonstrating delayed…

ByRidhi RastogiJune 23, 2026

NEWS

The MHLW Approves Sanofi’s Sarclisa SC Formulation to Treat Multiple Myeloma (MM)

Shots: The MHLW has approved Sarclisa (isatuximab; SC) + SoC for MM, while regulatory filing for the CirCLIQ on-body injector (OBI), based on the enFuse platform & submitted by Enable Injections, is under review; filing for both OBI & SC manual injection is under FDA review Approval was based on the P-III (IRAKLIA) study in R/R…

ByRidhi RastogiJune 19, 2026

NEWS

Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

Shots: The US FDA has granted accelerated approval to Sanofi's Tzield to delay the decline in endogenous (own) insulin production in pts (8-17yrs.) recently diagnosed with stage 3 T1D Approval was based on the P-III (PROTECT) trial assessing Tzield (n=217) vs PBO (n=111) in 328 children & adolescents (8-17yrs.) diagnosed with clinical stage 3 T1D…

ByRidhi RastogiJune 15, 2026

NEWS

Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

Shots: The US FDA has accepted NDA & granted priority review to Sanofi's venglustat for the treatment of neurological manifestations of type 3 Gaucher disease (GD3), with the PDUFA action date of Nov 25, 2026 NDA was supported by the ongoing P-III (LEAP2MONO) trial assessing venglustat (QD, PO) vs enzyme replacement therapy (IV, Q2W) in 43 pts…

ByRidhi RastogiMay 28, 2026

INSIGHTS+

EMA Marketing Authorization of New Drugs in April 2026

Shots: The European Medicines Agency advanced multiple approvals and late-stage recommendations in April 2026 across infectious diseases, neurology, immunology, endocrinology, and rare disorders, involving companies including Merck, Moderna, Novartis, Sanofi, and Mitsubishi Tanabe Pharma CHMP positive opinions included Redemplo for familial chylomicronemia syndrome, Itvisma for spinal muscular atrophy, and Cenrifki for non-relapsing SPMS The EC also approved therapies including Enflonsia for RSV prevention in infants, mCOMBRIAX for influenza/COVID-19 prevention, Palsonify for acromegaly, Rhapsido for…

ByDipanshu DixitMay 19, 2026

NEWS

Sanofi Reports P-II (ElevAATe) Trial Data on Efdoralprin alfa for Alpha-1 Antitrypsin Deficiency (AATD)-Related Emphysema

Shots: Sanofi has reported the P-II (ElevAATe) study data assessing efdoralprin alfa (Q3W or Q4W) vs SoC plasma-derived augmentation therapy (pdAAT; QW) in 97 pts with AATD-related emphysema Efdoralprin alfa achieved a mean increase in fAAT trough levels of 24.1μM (Q3W) & 16.8μM (Q4W) vs 7.6μM at Wk. 32, with Q3W meeting the 1EP, while…

ByRidhi RastogiMay 19, 2026

NEWS

Sanofi Reports the CHMP Positive Opinion for Cenrifki (Tolebrutinib) to Treat Non-Relapsing SPMS

Shots: The CHMP has recommended Sanofi's Cenrifki for the treatment of SPMS without relapses in the last 2yrs.; regulatory submissions are ongoing in other regions Opinion was backed by P-III (HERCULES) trial in non-relapsing SPMS & supporting data from P-III (GEMINI 1 & 2) studies in relapsing multiple sclerosis, with HERCULES demonstrating delayed onset of…

ByRidhi RastogiApril 27, 2026

TOP 20

Top 20 Biopharma Deal Terminations of 2025

Shots: Biopharma dealmaking in 2025 continued to face significant headwinds, with collaborations frequently collapsing due to strategic reprioritization, fierce competitive pressures, unfavorable clinical readouts, and failure to meet key closing conditions highlighting the inherent uncertainty and capital risk embedded in innovation-driven partnerships The year underscored a clear dominance of R&D-focused collaborations and licensing agreements,…

ByPrince GiriApril 24, 2026

NEWS

Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

Shots: FDA has approved Dupixent to treat CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, & P-III (CUPIDKids) trial Study A & C assessed Dupixent + SoC antihistamines (loading dose then 300mg Q2W; pts weighing <60kg received 200mg) vs PBO…

ByRidhi RastogiApril 23, 2026

Sanofi Reports P-III (Baby-COMET) Trial Data on Nexviazyme for Infantile-Onset Pompe Disease (IOPD)

Sanofi Reports the EC Approval for Cenrifki (Tolebrutinib) to Treat SPMS without Relapses

The MHLW Approves Sanofi’s Sarclisa SC Formulation to Treat Multiple Myeloma (MM)

Sanofi’s Tzield Secures FDA Accelerated Approval to Preserve Endogenous Insulin Production in Recently Diagnosed Stage 3 T1D

Sanofi’s Venglustat Secures the US FDA Priority Review for Type 3 Gaucher Disease

EMA Marketing Authorization of New Drugs in April 2026

Sanofi Reports P-II (ElevAATe) Trial Data on Efdoralprin alfa for Alpha-1 Antitrypsin Deficiency (AATD)-Related Emphysema

Sanofi Reports the CHMP Positive Opinion for Cenrifki (Tolebrutinib) to Treat Non-Relapsing SPMS

Top 20 Biopharma Deal Terminations of 2025

Regeneron and Sanofi Report the US FDA Approval of Dupixent (Dupilumab) for Chronic Spontaneous Urticaria (CSU)

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