Shots :Regeneron highlighted the data at RAD’25 from the P-IV (DISCOVER) study evaluating Dupixent in pts (N=120) with atopic dermatitis with skin of color that received Dupixent as monotx. Q2W based on weight after loading dose: 200mg for 30-60kg pts & 300mg for ≥60kg ptsDupixent achieved a ≥75% improvement in overall disease severity…
Shots:Regeneron has entered into an in-licensing agreement with Hansoh for exclusive global clinical development & commercialization rights of HS-20094, excl. Mainland China, Hong Kong & MacauAs per the deal, Hansoh will receive $80M upfront & ~$1.93B in development, regulatory & sales milestones, with low double digits royalties on sales in Regeneron-licensed areasHS-20094…
Shots:P-III (AERIFY-1 & AERIFY-2) trials assessed itepekimab (SC, Q2W or Q4W) vs PBO as an add-on therapy in pts (40-85yrs.) with mod. to sev. COPD, who haven’t smoked for ≥6mos.; data to be discussed with regulatory bodies AERIFY-1 (n=1127) met its 1EP of reduced exacerbations, with Q2W (n=375) showing a 27% reduction at Wk.…
Shots:Viz.ai has entered into a multi-year collaboration with Sanofi & Regeneron to deploy and evaluate its AI-powered chronic obstructive pulmonary disease (COPD) workflow solutionSanofi, Regeneron, and Viz.ai collaborated on an AI-powered solution to improve care for high-risk COPD pts, focusing on how the Viz COPD module can enhance EHR workflows, access to care,…
Shots:Regeneron has entered into an asset purchase agreement with 23andMe for $256M, strengthening Regeneron’s genetics-guided research & drug development activitiesRegeneron to acquire key assets of 23andMe, incl. Personal Genome Service, Total Health & Research Services business lines, plus its Biobank & associated assets, with services continuing uninterrupted; closing is expected in Q3’2523andMe…
Shots:The EC has granted conditional approval to Lynozyfic for the treatment of adults with r/r multiple myeloma based on P-I/II (LINKER-MM1) trial data assessing Lynozyfic in >300 pts; P-II dose expansion portion is ongoing. BLA under the US FDA’s Review (PDUFA: Jul 10, 2025)In the trial, 117 pts on 200mg had a 71% ORR, with…
Shots:FUJIFILM Diosynth Biotechnologies & Regeneron have entered into a 10-year manufacturing supply agreement, under which FUJIFILM will provide US-based manufacturing services for RegeneronAs per the deal, FUJIFILM will receive ~$3B to manufacture biopharmaceuticals for Regeneron at its Holly Springs, North Carolina facility, which will begin operations in late 2025Holly Springs site is…
Shots:The US FDA has approved Dupixent to treat CSU pts (≥12yrs.), who were symptomatic despite H1 antihistamine treatment based on 2 P-III (Study A & C) trials from LIBERTY-CUPID program; regulatory review ongoing in EU & other regionsStudy A & C assessed Dupixent (loading dose then 300mg Q2W; pts weighing <60kg received 200mg)…
Shots:Regeneron reported the US FDA acceptance for its priority review of the sBLA by using priority review voucher for EYLEA HD (aflibercept 8 mg) to treat macular edema from retinal vein occlusion (RVO) and to expand dosing to include monthly administration in all approved indications. The US FDA’s expected action date is Aug 19,…
Shots:Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK,…

