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Biocon Biologics
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,…
April 16, 2025

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Sanofi & Regeneron
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)…
March 28, 2025

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Regeneron
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…
March 3, 2025

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Regeneron
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…
February 25, 2025

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Regeneron
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)…
February 12, 2025

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Regeneron New
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…
January 15, 2025

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Regeneron
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…
August 24, 2024

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Regeneron
NEWS

Regeneron’s Ordspono Gains the CHMP’s Positive Opinion to Treat r/r Follicular Lymphoma (FL) or Diffuse Large B-Cell Lymphoma (DLBCL) 

Shots:  The CHMP has granted a positive opinion for conditional marketing authorization of odronextamab (CD20xCD3 bispecific Ab) to treat r/r FL or r/r DLBCL post ≥2L of therapies, with the EC’s decision anticipated in the upcoming mos.  The opinion was based on the P-I (ELM-1) & pivotal P-II (ELM-2) studies, showing strong durable response rates…
June 28, 2024

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