EMA Marketing Authorization of New Drugs in November 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 November, the EMA issued positive CHMP opinions for six significant therapies and 2 EU approval: Sanofi’s Teizeild (Teplizumab) to delay the onset of stage 3 type 1 diabetes, and Ionis and Otsuka’s Dawnzera (Donidalorsen) for the routine prevention of HAE attacks In…

ByDipanshu DixitDecember 16, 2025

NEWS

STADA & Bio-Thera Receive the CHMP Positive Opinion for Gotenfia (Biosimilar, Simponi)

Shots: The CHMP has recommended STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), for EC approval valid in all 30 EEA states Opinion was based on extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects, plus P-III…

ByRidhi RastogiDecember 12, 2025

NEWS

Samsung Bioepis Receive the CHMP Positive Opinion for Byooviz (Biosimilar, Lucentis)

Shots: The CHMP has recommended Samsung Bioepis’ Byooviz (0.5 mg/0.05 ml PFS), a biosimilar version of Lucentis (ranibizumab). The PFS presentation is expected to launch in Q2’26 Byooviz is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), and…

ByDipanshu DixitDecember 2, 2025

NEWS

AbbVie Reports P-III (ECLIPSE) Trial Data on Aquipta (Atogepant) for the Acute Treatment of Migraine

Shots: AbbVie has reported the P-III (ECLIPSE) trial data assessing Aquipta/Qulipta (atogepant, 60mg, PO, QD) vs PBO as an acute treatment of migraine in 1,223 adults (with or without aura) Trial met its 1EP, showing atogepant was superior to PBO for pain freedom at 2hrs. in the first treated migraine attack (with or without aura; 24.3%…

ByRidhi RastogiDecember 1, 2025

NEWS

Cosmo and Glenmark Reports the EC Approval on Winlevi to Treat Acne Vulgaris Across 17 countries in EU

Shots: The EC has approved Cosmo Pharmaceuticals and Glenmark Pharmaceuticals’ Winlevi (clascoterone 10 mg/g cream) for the Treatment of Acne Vulgaris in 17 countries in Europe Winlevi is authorized in the EU for treating acne vulgaris in adults and adolescents aged 12 to <18 years, with adolescent use limited to facial application Following approval, Glenmark will begin commercializing Winlevi across 17 European countries, including Belgium, France, Spain,…

ByDipanshu DixitDecember 1, 2025

NEWS

BeOne Medicines Reports the US FDA’s NDA Acceptance of Sonrotoclax with Priority Review for R/R Mantle Cell Lymphoma

Shots: The US FDA has accepted NDA & granted priority review to sonrotoclax for adults with r/r mantle cell lymphoma following treatment with a BTK inhibitor NDA was supported by the global P-I/II (BGB-11417-201) assessing sonrotoclax in r/r MCL pts (n=125), which met its 1EP of improved ORR per IRC, with benefits seen across…

ByRidhi RastogiNovember 26, 2025

INSIGHTS+

New Drug Designations – October 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 October 2025 report covers designations granted to 56 drugs and 9 medical devices, spanning 23 small molecules, 14 biologics, 10 cell and gene therapies & 9 medical devices, among…

ByRidhi RastogiNovember 25, 2025

INSIGHTS+

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

The CHMP Recommends Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The CHMP has recommended Dawnzera for the routine prevention of HAE attacks in pts (≥12yrs.) following the US FDA approval in Aug 2025; EC’s decision is expected in Q1’26 Opinion was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate even when Dawnzera…

ByRidhi RastogiNovember 17, 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

EMA Marketing Authorization of New Drugs in November 2025

STADA & Bio-Thera Receive the CHMP Positive Opinion for Gotenfia (Biosimilar, Simponi)

Samsung Bioepis Receive the CHMP Positive Opinion for Byooviz (Biosimilar, Lucentis)

AbbVie Reports P-III (ECLIPSE) Trial Data on Aquipta (Atogepant) for the Acute Treatment of Migraine

Cosmo and Glenmark Reports the EC Approval on Winlevi to Treat Acne Vulgaris Across 17 countries in EU

BeOne Medicines Reports the US FDA’s NDA Acceptance of Sonrotoclax with Priority Review for R/R Mantle Cell Lymphoma

New Drug Designations – October 2025

EMA Marketing Authorization of New Drugs in October 2025

The CHMP Recommends Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

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

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