EMA Marketing Authorization of New Drugs in October 2025

Shots: Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier In October, the EMA issued positive CHMP opinions for two significant therapies: Sanofi’s Wayrilz (rilzabrutinib) for adults with immune thrombocytopenia, and Insmed’s Brinsupri (brensocatib) for the…

ByDipanshu DixitNovember 18, 2025

NEWS

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

Shots: The CHMP has recommended Teizeild 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 Opinion was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32) for 14 days in 76…

ByRidhi RastogiNovember 17, 2025

NEWS

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

Shots: Sanofi has reported the P-II (ElevAATe) trial data assessing efdoralprin alfa (Q3W or Q4W) vs SoC plasma-derived augmentation therapy (QW) in 97 adults with AATD emphysema for ~32wks. Trial met its 1EP with a greater mean increase in functional AAT (fAAT) levels at Wk. 32 & achieved key 2EPs of higher fAAT levels &…

ByRidhi RastogiOctober 24, 2025

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Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

Shots: The CHMP has recommended Wayrilz (rilzabrutinib) for adults with ITP unresponsive to other treatments, with a final decision expected soon; under regulatory review for ITP in China Opinion was based on the P-III (LUNA 3) trial assessing Wayrilz (400mg, BID, PO) vs PBO during a 12–24-wk, followed by 28 wks, and then a four-week…

ByDipanshu DixitOctober 22, 2025

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EVOQ Therapeutics Signs a ~$500M Deal with Sanofi for NanoDisc Technology

Shots: EVOQ Therapeutics has entered into a collaboration & license agreement with Sanofi to advance EVOQ’s NanoDisc tech in immunology As per the deal, both companies will jointly lead research activities, with Sanofi responsible for global development & commercialization efforts. In exchange, EVOQ will receive over $500M, incl. upfront, preclinical, development & sales milestones, with tiered…

ByRidhi RastogiOctober 17, 2025

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Sanofi Reports P-II (ALPHAMEDIX-02) Trial Data of AlphaMedix for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

Shots: Sanofi has reported data from the ongoing P-II (ALPHAMEDIX-02) trial assessing AlphaMedix (67.6μCi/kg, Q8W, ~4 cycles) in pts, incl. PRRT-naïve (n=35) & exposed (n=26) pts with histologically confirmed unresectable or metastatic SSTR+ GEP-NETs & ≥1 site of measurable disease Trial met all 1EPs with improved ORR & prolonged benefit, plus showed improvement across 2EPs…

ByRidhi RastogiOctober 8, 2025

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Top 20 Monoclonal Antibodies of 2025

Shots: Redefining treatment paradigms, monoclonal antibody therapies utilize advanced mechanisms of action to provide care across multiple therapeutic areas As of 2024, the global monoclonal antibody therapy market was valued at $252.6B and is projected to reach $497.5B by 2029, growing at a CAGR of 14.5%. Keytruda leads the market with $29.48B in revenue, followed…

ByPrince GiriSeptember 18, 2025

NEWS

Sanofi Reports P-IIa (HS-OBTAIN) Trial Data of Brivekimig for Hidradenitis Suppurativa

Shots: Sanofi has reported the P-IIa (HS-OBTAIN) trial data assessing brivekimig (150mg, SC, Q2W) vs PBO in pts with mod. to sev. hidradenitis suppurativa, incl. biologic-naïve pts for 16 wks., followed by a 12wk. open-label period & an 8wk. safety follow-up At 16wks., brivekimig achieved higher HiSCR50 median response rates of 67% vs 37%, with 54%…

ByRidhi RastogiSeptember 17, 2025

NEWS

Sanofi’s Tzield Receives the NMPA’s Approval to Delay Progression of Type 1 Diabetes

Shots: China’s NMPA has approved Tzield (teplizumab) 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 EU & other regions Approval was based on the P-II (TN-10) trial assessing Tzield (QD for 14 days) vs PBO, which…

ByRidhi RastogiSeptember 10, 2025

TOP 20

Top 20 Oncology Companies of 2025

Shots: ADCs, cell therapies, and radioligand therapies are reshaping oncology, while biopharma companies focus on smarter trials, patient-first approaches, and faster access to bridge unmet needs in cancer care In 2024, the global oncology market was valued at $225.01B and is projected to reach $668.26B by 2034, reflecting a strong CAGR of 11.5% from 2025…

ByPrince GiriSeptember 3, 2025

EMA Marketing Authorization of New Drugs in October 2025

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

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

Sanofi’s Wayrilz (Rilzabrutinib) Receives the CHMP’s Positive Opinion to Treat Immune Thrombocytopenia (ITP)

EVOQ Therapeutics Signs a ~$500M Deal with Sanofi for NanoDisc Technology

Sanofi Reports P-II (ALPHAMEDIX-02) Trial Data of AlphaMedix for Gastroenteropancreatic Neuroendocrine Tumors (GEP-NET)

Top 20 Monoclonal Antibodies of 2025

Sanofi Reports P-IIa (HS-OBTAIN) Trial Data of Brivekimig for Hidradenitis Suppurativa

Sanofi’s Tzield Receives the NMPA’s Approval to Delay Progression of Type 1 Diabetes

Top 20 Oncology Companies of 2025

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