Samsung Bioepis Inks Settlement and Licensing Deal with Regeneron and Bayer for Commercialization of SB15 (Biosimilar, Eylea)

Shots: Samsung Bioepis has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of SB15, a biosimilar version of Eylea 2 mg (aflibercept 40 mg/mL solution), in markets excluding the US and Canada The agreement allows Samsung Bioepis to launch SB15 in the UK from Jan 2026, across the EU from Apr 2026,…

ByDipanshu DixitJanuary 29, 2026

NEWS

GSK’s Arexvy Receives the EC Approval to Prevent Respiratory Syncytial Virus (RSV) Disease

Shots: The EC has approved the Arexvy RSV vaccine for adults ≥18 yrs in Europe. While it was previously authorized only for adults ≥50 yrs at risk The adjuvanted RSV vaccine includes a stabilized form of a protein from the respiratory syncytial virus (RSV), called the prefusion F protein (RSVPreF3), combined with GSK’s AS01E adjuvant,…

ByDipanshu DixitJanuary 27, 2026

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

INSIGHTS+

EMA Marketing Authorization of New Drugs in September 2025

Shots: The EMA’s CHMP has granted approvals to 5 Biologics and 5 new chemical entities in September 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug, Merck’s Enflonsia, has Adopted Positive Opinion for RSV Prevention in Infants PharmaShots has compiled a list of 9 drugs that have been…

ByDipanshu DixitOctober 21, 2025

VIEWPOINTS

Unlocking Approval: Sofie Berg from AbbVie in a Riveting Conversation with PharmaShots

Shots: AbbVie adds an eighth indication to Rinvoq’s label with the European Commission’s approval for treating adult patients with giant cell arteritis (GCA) Sofie Berg, Therapeutic Area Head of International Immunology at AbbVie, in a conversation with PharmaShots, shares insights from the SELECT-GCA trial evaluating Rinvoq in GCA, highlighting both primary and secondary endpoints Rinvoq…

BySaurabh ChaubeyJuly 9, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 2 Biologics and 1 New Chemical Entity in March 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Merck’s Capvaxive to treat invasive pneumococcal disease PharmaShots has compiled a list of 3 drugs that have been…

ByDipanshu DixitApril 22, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in February 2025

Shots: The EMA’s CHMP has granted positive opinions and approvals to 5 Biologics and 2 New Chemical Entities in February 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Merck’s Welireg to treat Von Hippel-Lindau & Renal Cell Carcinoma PharmaShots has compiled a list of 6 drugs…

ByDipanshu DixitMarch 18, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in January 2025

Shots: The EMA’s CHMP has granted positive opinions to 5 Biologics in January 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Merck’s Capvaxive to treat Pneumococcal Disease PharmaShots has compiled a list of 4 drugs that have been granted positive opinions and approvals by the EMA’s…

ByDipanshu DixitFebruary 18, 2025

INSIGHTS+

EMA Marketing Authorization of New Drugs in December 2024

Shots: The EMA’s CHMP has granted positive opinions to 5 Biologics and 4 New Chemical Entities in December 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Galderma’s Nemluvio to treat Prurigo Nodularis and Atopic Dermatitis PharmaShots has compiled a list of 9 drugs that have been granted positive…

ByDipanshu DixitJanuary 23, 2025

NEWS

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The EC has approved Sarclisa with SoC VRd (bortezomib, lenalidomide, & dexamethasone) to treat ASCT-ineligible NDMM patients, following the CHMP’s positive opinion. Regulatory findings are under review in Japan & China Approval was based on a P-III (IMROZ) study assessing Sarclisa + VRd vs VRd, which showed improved PFS of 40% (1EP) with findings reported…

ByRidhi RastogiJanuary 22, 2025

Samsung Bioepis Inks Settlement and Licensing Deal with Regeneron and Bayer for Commercialization of SB15 (Biosimilar, Eylea)

GSK’s Arexvy Receives the EC Approval to Prevent Respiratory Syncytial Virus (RSV) Disease

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

EMA Marketing Authorization of New Drugs in September 2025

Unlocking Approval: Sofie Berg from AbbVie in a Riveting Conversation with PharmaShots

EMA Marketing Authorization of New Drugs in March 2025

EMA Marketing Authorization of New Drugs in February 2025

EMA Marketing Authorization of New Drugs in January 2025

EMA Marketing Authorization of New Drugs in December 2024

The EC Approves Sanofi’s Sarclisa + standard-of-care VRd to Treat Newly Diagnosed Multiple Myeloma (NDMM)

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