The US FDA Accepts sBLA Priority Review for Regeneron’s EYLEA HD in Macular Edema Following RVO and Monthly Dosing In Approved Indications

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,…

ByRidhi RastogiApril 18, 2025

News

Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

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 H2’26 Yesafili’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,…

ByRidhi RastogiApril 16, 2025

News

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots: Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapy Approval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…

ByRidhi RastogiMarch 28, 2025

News

The CHMP Recommends Conditional Approval of Regeneron’s Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Shots: The CHMP has recommended conditional approval of linvoseltamab for r/r MM pts who had ≥3 prior therapies (incl. proteasome inhibitor, immunomodulator, & anti-CD38 mAb) & had disease progression on last therapy, following the US FDA’s BLA acceptance (PDUFA: Jul 10, 2025) Opinion was based on P-I/II (LINKER-MM1) trial data assessing linvoseltamab (200mg; QW then…

ByDipanshu DixitMarch 3, 2025

News

Regeneron Presents P-I/II (CHORD) Trial Data of DB-OTO for Profound Genetic Hearing Loss at Association for Research in Otolaryngology 2025

Shots: Ongoing P-I/II (CHORD) trial assessed DB-OTO (intracochlear) in 12 pts (10mos.-16yrs.) with hearing loss due to variation in OTOF gene, where 9 pts received it in 1 ear, while 3 received it in both; pts enrolment (<18yrs.) ongoing in the US, UK & Spain At 48 wks., first subject (10mos. old) showed improved…

ByRidhi RastogiFebruary 25, 2025

News

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

Shots: The US FDA has accepted & granted priority review to the sBLA of Dupixent for the treatment of adults with BP (PDUFA: Jun 20, 2025) sBLA was supported by P-II/III (ADEPT) trial assessing Dupixent vs PBO in pts (n=106) for 52wks., that met its 1EP of 5x pts achieving sustained disease remission at…

ByRidhi RastogiFebruary 18, 2025

News

Regeneron Reports US FDA’s Acceptance of Resubmitted BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Shots: The US FDA has accepted resubmitted BLA for linvoseltamab to treat r/r MM in pts who received ≥4L or ≥3L & were unresponsive to the last line (PDUFA: Jul 10, 2025) after resolving third-party fill/finish manufacturing issues; MAA is under EMA review Application was backed by P-I/II (LINKER-MM1) trial data, assessing linvoseltamab (200mg)…

ByRidhi RastogiFebruary 12, 2025

News

Regeneron Reveals Data from Extended P-III (PULSAR) Trial of Eylea HD for Wet Age-related Macular Degeneration

Shots: Regeneron reported 3yr. data from an extension study of P-III (PULSAR) trial of Eylea for wAMD pts, randomized to Eylea HD (8mg; Q3M or Q4M) or Eylea (2mg; Q2M) After 2yrs., 88% of Eylea HD patients maintained a dosing interval of ≥3 months, while in 60wk. extension, 77%, 58%, 40% & 24% (out…

ByRidhi RastogiFebruary 10, 2025

News

Regeneron Reports Interim Data from P-III (C-POST) Trial of Libtayo Adjuvant to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Shots: The P-III (C-POST) trial assessed Libtayo adj. (n=205; 350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.) vs PBO (n=204) to treat high-risk CSCC patients (N=415) for ~48wks. Study met its first prespecified interim analysis, showing 68% reduced disease occurrence & death risk at 24mos. median follow-up, with additional…

ByRidhi RastogiJanuary 15, 2025

News

Regeneron’s Ordspono (Odronextamab) Receives the EC’s Approval to Treat R/R Follicular Lymphoma and Diffuse Large B-cell Lymphoma

Shots: The EC has approved Ordspono for treating r/r FL or r/r DLBCL in patients who have progressed after ≥2L of systemic therapy Approval was supported by Ordspono’s P-I (ELM-1; n=60) trial in patients with CD20+ B-cell malignancies, incl. those who progressed post CAR-T therapy & P-II (ELM-2; n=128) trial for 5 B-cell lymphoma…

ByDipanshu DixitAugust 24, 2024

The US FDA Accepts sBLA Priority Review for Regeneron’s EYLEA HD in Macular Edema Following RVO and Monthly Dosing In Approved Indications

Biocon Biologics and Regeneron Settle over Yesafili’s (Biosimilar, Eylea) US Launch

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

The CHMP Recommends Conditional Approval of Regeneron’s Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Regeneron Presents P-I/II (CHORD) Trial Data of DB-OTO for Profound Genetic Hearing Loss at Association for Research in Otolaryngology 2025

Regeneron and Sanofi Report the US FDA’s sBLA Acceptance for Dupixent to Treat Bullous Pemphigoid (BP)

Regeneron Reports US FDA’s Acceptance of Resubmitted BLA for Linvoseltamab to Treat R/R Multiple Myeloma (MM)

Regeneron Reports Interim Data from P-III (C-POST) Trial of Libtayo Adjuvant to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Regeneron’s Ordspono (Odronextamab) Receives the EC’s Approval to Treat R/R Follicular Lymphoma and Diffuse Large B-cell Lymphoma

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