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

NEWS

Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

Shots: The US FDA has approved Sanofi's Tzield (teplizumab-mzwv), under priority review, to delay of the onset of stage 3 T1D in pts (≥1yr.) diagnosed with stage 2 T1D Approval was supported by 1yr. data from the ongoing P-IV (PETITE-T1D) trial assessing the safety & PK of Tzield (IV, QD for 14 consecutive days) in…

ByRidhi RastogiApril 22, 2026

INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026

Shots: The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…

ByDipanshu DixitApril 21, 2026

NEWS

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

Shots: The EC has approved Dupixent to treat mod. to sev. CSU pts (age 2-11yrs.), who were symptomatic despite H1 antihistamine treatment & naïve to anti-IgE therapy based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program, and CUPIDKids Study A & C assessed Dupixent (LD → 300mg Q2W or 200mg Q2W for…

ByDipanshu DixitApril 13, 2026

TOP 20

Top 20 Biopharma Companies of 2026

Shots: The biopharma industry is a multi-hundred-billion-dollar market, with a projected compound annual growth rate (CAGR) of 8.6%, the global biopharma market is expected to reach $1.41T by 2034. Eli Lilly and Co. ranked first with $65.17B, followed by Pfizer ($61.19B) and AbbVie ($61.16B), reflecting strong market concentration among large-cap innovators with diversified, high-value portfolios …

ByPrince GiriApril 10, 2026

NEWS

Sanofi Reports Market Authorization for Nuvaxovid, Expanding COVID-19 Vaccine Options in Canada

Shots: Sanofi became the Nuvaxovid market authorization holder in Canada to supply the protein-based COVID-19 vaccine. Nuvaxovid to be available in Canada for the fall 2026-2027 season Authorization was supported by pivotal P-III trials demonstrating ~90% efficacy of Nuvaxovid in preventing symptomatic COVID-19. Demonstrated a favourable tolerability profile, supporting its use for seasonal vaccination Nuvaxovid…

ByDipanshu DixitApril 9, 2026

NEWS

Sanofi Reports P-II Trial Results on Lunsekimig Across Multiple Immunology & Inflammatory Indications

Shots: Sanofi has reported P-IIb (AIRCULES), P-IIa (DUET) PoC & P-IIb (VELVET) data assessing lunsekimig (SC) in adults with mod. to sev. asthma, CRSwNP, & in mod. to sev. atopic dermatitis, respectively In AIRCULES, lunsekimig met 1 & 2EPs, reducing exacerbations & improving lung fuction as measured by pre-BD FEV1 vs PBO, while in DUET it met…

ByRidhi RastogiApril 7, 2026

NEWS

Sanofi Reports the EC Approval of Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

Shots: The EC has approved Rezurock (200mg) to treat chronic GVHD pts (≥12yrs., ≥40kg) Approval was based on safety and efficacy clinical data, incl. the P-II (ROCKstar) trial (n=77), which showed an improved ORR of 74% in chronic GVHD pts post–stem cell transplant & after ≥2 prior systemic therapies Under the conditional marketing authorisation, Sanofi will conduct a confirmatory randomized study Ref:…

ByDipanshu DixitMarch 26, 2026

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)

Sanofi Reports the US FDA Approval of Tzield to Delay Onset of Stage 3 Type 1 Diabetes in Children (≥1years)

EMA Marketing Authorization of New Drugs in March 2026

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

Top 20 Biopharma Companies of 2026

Sanofi Reports Market Authorization for Nuvaxovid, Expanding COVID-19 Vaccine Options in Canada

Sanofi Reports P-II Trial Results on Lunsekimig Across Multiple Immunology & Inflammatory Indications

Sanofi Reports the EC Approval of Rezurock (Belumosudil) to Treat Chronic Graft-vs-Host Disease (GVHD)

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