Stoke Therapeutics and Biogen Report First Patient Dosing in P-III (EMPEROR) Trial of Zorevunersen for Dravet Syndrome

Shots: Stoke Therapeutics & Biogen have dosed their first patient with zorevunersen in global P-III (EMPEROR) trial for the treatment of Dravet syndrome; Trial has initiated in the US, UK, & Japan, with an EU study planned Trial will assess zorevunersen (70mg on Day 1 & Wk. 8, then 45mg at Wks. 24 & 40) vs sham…

ByRidhi Rastogi2 days ago

NEWS

Biogen’s Zurzuvae Receives the CHMP’s Positive Opinion to Treat Severe Postpartum Depression

Shots: The CHMP has recommended Zurzuvae (zuranolone) for the treatment of postpartum depression in adults; EC’s decision is expected in Q3’25 Approval was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depression Trial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15,…

ByRidhi RastogiJuly 28, 2025

TOP 20

Top 20 Immunology Companies of 2025

Shots: Immunology continues to be a key focus area, with biopharmaceutical companies rigorously advancing innovative therapies including drugs, vaccines, and antibodies to address evolving patient needs and improve disease outcomes In 2024, the global immunology market size was valued at $109.4B and expected to reach $254.23B by 2032, with a CAGR of 11.8% from 2024…

ByPrince GiriJuly 24, 2025

NEWS

Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the US

Shots: Samsung Bioepis has entered into a definitive agreement to grant Harrow exclusive commercial rights of its ophthalmology biosimilar portfolio incl. Byooviz, biosimilar to Lucentis (ranibizumab), & Opuviz, biosimilar to Eylea (aflibercept) in the US Byooviz has been available in the US through Biogen since its launch in Jun 2022. In Oct 2024, Biogen notified…

ByRidhi RastogiJuly 18, 2025

NEWS

Supernus Pharmaceuticals to Acquire Sage Therapeutics for ~$795M

Shots: Supernus to acquire Sage Therapeutics, strengthening its neuropsychiatry product portfolio with Zurzuvae (zuranolone), & a novel CNS discovery platform As per the deal, Sage’s shareholders will receive $8.5/share in an all-cash transaction totaling ~$561M, along with one non-tradeable CVR of $3.50/share (~$234M) tied to Zurzuvae milestones: $1 each for US sales allocable to Supernus reaching $250M (by…

ByRidhi RastogiJune 17, 2025

NEWS

Biogen Joins Forces with City Therapeutics to Develop Novel RNAi Therapies

Shots: Biogen has collaborated with City Therapeutics to develop novel RNAi therapies, leveraging the former’s drug delivery tech & City’s RNAi engineering tech As per the deal, City will receive $46M incl. $16M upfront + $30M investment in exchange for its convertible note, also eligible to receive ~$1B as development & commercial milestones, with high…

ByRidhi RastogiMay 28, 2025

NEWS

Eisai, Biogen and BioArctic Report the EC’s Approval of Leqembi (lecanemab) for Early Alzheimer’s Disease

Shots: The EC has approved Leqembi for the treatment of early Alzheimer’s disease in all 30 EEA states Eisai handles global development & regulatory filings for Leqembi, co-commercializing & co-promoting it with Biogen while retaining final decision-making authority. Eisai co-promotes Leqembi with Biogen in the EU (excl. Nordics) & with BioArctic in the Nordic countries, distributing it…

ByRidhi RastogiApril 16, 2025

NEWS

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen

Shots: Organon has acquired the US regulatory & commercial rights for Tofidence, a biosimilar version of Actemra (tocilizumab), from Biogen, which retains manufacturing rights in the US As per the deal, Biogen will receive upfront, while Organon will assume Biogen's obligation to pay Bio-Thera tiered annual net sales royalties & milestones Tofidence is a humanized…

ByRidhi RastogiApril 2, 2025

NEWS

Biogen Collaborates with Stoke Therapeutics to Develop and Commercialize Zorevunersen for Dravet Syndrome

Shots: Biogen & Stoke have partnered to develop & market zorevunersen for Dravet syndrome with Stoke retaining rights in the US, Canada, & Mexico while leading global development & Biogen securing marketing rights in other regions As per the deal, Stoke will get $165M upfront, ~$385M in development & commercial milestones, & net sales-based…

ByRidhi RastogiFebruary 19, 2025

VIEWPOINTS

Biogen at WMS 2024: Stephanie Fradette from Biogen in an Illuminating Dialogue Exchange with PharmaShots

Shots: Biogen recently shared findings from the P-II/III DEVOTE study, which investigated the safety and efficacy of a higher dose regimen of Spinraza for the treatment of spinal muscular atrophy (SMA) Stephanie Fradette, Head of Neuromuscular Development Unit at Biogen, joins PharmaShots for a stimulating conversation on Biogen's groundbreaking presentation at World Muscle Society 2024. …

BySaurabh ChaubeyFebruary 19, 2025

Stoke Therapeutics and Biogen Report First Patient Dosing in P-III (EMPEROR) Trial of Zorevunersen for Dravet Syndrome

Biogen’s Zurzuvae Receives the CHMP’s Positive Opinion to Treat Severe Postpartum Depression

Top 20 Immunology Companies of 2025

Samsung Bioepis Collaborates with Harrow to Commercialize its Ophthalmology Biosimilars in the US

Supernus Pharmaceuticals to Acquire Sage Therapeutics for ~$795M

Biogen Joins Forces with City Therapeutics to Develop Novel RNAi Therapies

Eisai, Biogen and BioArctic Report the EC’s Approval of Leqembi (lecanemab) for Early Alzheimer’s Disease

Organon Acquires Regulatory and Commercial Rights of Tofidence IV Infusion (Biosimilar, Actemra) from Biogen

Biogen Collaborates with Stoke Therapeutics to Develop and Commercialize Zorevunersen for Dravet Syndrome

Biogen at WMS 2024: Stephanie Fradette from Biogen in an Illuminating Dialogue Exchange with PharmaShots

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