Regeneron Reports the CHMP’s Positive Opinion for Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Shots:The CHMP has recommended Libtayo (cemiplimab) as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiationOpinion was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks. followed by 700mg, IV, Q6W for 36wks.; n=209) vs PBO (n=206) to treat…

ByRidhi RastogiOctober 21, 2025

NEWS

Regeneron Reports the US FDA’s Approval of Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Shots:The US FDA has approved Libtayo (cemiplimab-rwlc) under priority review as an adj. treatment for CSCC adults who are at high risk for recurrence after surgery & radiation; application under EMA’s review, with decision expected in H1’26Approval was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks.…

ByRidhi RastogiOctober 9, 2025

NEWS

Regeneron Reports Follow-Up Data from P-III (EMPOWER-Lung 3) Trial of Libtayo (Cemiplimab) to Treat NSCLC

Shots:The P-III (EMPOWER-Lung 3) trial assessed Libtayo (350mg, Q3W for 108wks.; n=312) vs PBO (n=154), both with Pt-based CT (Q3W ×4 cycles), in 466 adults with LA/M NSCLC harboring no EGFR, ALK, or ROS1 alterationAt mFU of 60.9mos., trial showed a 34% reduction in death risk (mOS: 21.1 vs 12.9mos.; 5yr. survival probability:…

ByRidhi RastogiSeptember 11, 2025

NEWS

Regeneron Reports P-III (NIMBLE) Trial Data of Cemdisiran for Generalized Myasthenia Gravis (gMG)

Shots:The P-III NIMBLE trial enrolled adults with symptomatic gMG & anti-AChR antibodies, randomizing them to cemdisiran (600mg, SC, Q12W, n=64), cemdi-poze (SC, Q4W, n=67), or PBO (n=59), with completion rates of 100%, 96%, & 90%, respectively; FDA’s filing is expected in Q1’26, pending discussionsTrial met its 1EP of improved MG-ADL total score, showing…

ByRidhi RastogiAugust 27, 2025

TOP 20

Top 20 R&D Spending Biopharma Companies of 2025

Shots: Research and Development (R&D) serves as the driving force behind groundbreaking therapeutic innovations, laying the foundation for advancements that transform patient health and overall well-being The global Top 20 pharmaceutical leaders spent ~$180B in 2024, with Merck & Co. contributing the most with a whopping $17.93B, followed by Johnson & Johnson ($17.23B) and Roche…

ByPrince GiriAugust 21, 2025

INSIGHTS+

The US FDA New Drug Approvals in July 2025

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of July 2025 The US FDA has approved a total of 6 new drugs, including 5 new molecular entities and 1 biologic, leading to the treatment of patients and advances in the pharmaceutical industry The major highlighted drug was Regeneron’s Lynozyfic, securing…

ByDipanshu DixitAugust 12, 2025

NEWS

Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

Shots:The US FDA has granted accelerated approval to Lynozyfic for the treatment of r/r MM pts, who have received ≥4L therapy, incl. a proteasome inhibitor, an immunomodulatory agent & an anti CD38 mAb based on P-I/II (LINKER-MM1) trial in >300 pts; a SC P-I trial portion & IV P-II dose expansion portion is ongoingIn…

ByRidhi RastogiJuly 3, 2025

VIEWPOINTS

Regeneron at ASH’24: Aafia Chaudhry in a Stimulating Dialogue Exchange with PharmaShots

Shots: Recently, Regeneron presented Odronextamab’s data in treating patients with different B-NHL subtypes (OLYMPIA studies) and marginal zone lymphoma (ELM-2 study) Aafia Chaudhry, Vice President, Global Program Head for Hematology-Oncology at Regeneron, discusses Odronextamab’s ongoing studies as monotherapy and in combination to treat various malignancies Aafia shares the upcoming PDUFA date on July 30th for…

BySaurabh ChaubeyJuly 2, 2025

VIEWPOINTS

Enhancing Hematologic Care: Lorah Perlee from Regeneron in a Riveting Dialogue Exchange with PharmaShots

Shots: At ASH 2024, Regeneron shared data from the P-III exploratory cohort investigating the pozelimab and cemdisiran combination (poze-cemdi) in patients with paroxysmal nocturnal hemoglobinuria The novel combination (poze-cemdi) achieved meaningful control of intravascular hemolysis compared to ravulizumab PharmaShots welcomes Lorah Perlee, Vice President, Global Program Head, Hematology and Translational Sciences at Regeneron, for an…

BySaurabh ChaubeyJune 23, 2025

NEWS

Regeneron and Sanofi Receive the US FDA’s Approval for Dupixent to Treat Bullous Pemphigoid

Shots:The US FDA has approved Dupixent to treat adults with bullous pemphigoid based on P-II/III (ADEPT) trial assessing Dupixent vs PBO for 52wks.; regulatory review is ongoing in the EU, Japan, & ChinaPts (n=106) received a loading dose of Dupixent (300mg; n=53) or PBO (n=53), followed by Q2W dosing with OCS. OCS tapering began at Wks.…

ByRidhi RastogiJune 20, 2025

Regeneron Reports the CHMP’s Positive Opinion for Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Regeneron Reports the US FDA’s Approval of Adjuvant Libtayo to Treat High-Risk Cutaneous Squamous Cell Carcinoma (CSCC)

Regeneron Reports Follow-Up Data from P-III (EMPOWER-Lung 3) Trial of Libtayo (Cemiplimab) to Treat NSCLC

Regeneron Reports P-III (NIMBLE) Trial Data of Cemdisiran for Generalized Myasthenia Gravis (gMG)

Top 20 R&D Spending Biopharma Companies of 2025

The US FDA New Drug Approvals in July 2025

Regeneron’s Lynozyfic (Linvoseltamab-gcpt) Receives the US FDA’s Accelerated Approval for R/R Multiple Myeloma

Regeneron at ASH’24: Aafia Chaudhry in a Stimulating Dialogue Exchange with PharmaShots

Enhancing Hematologic Care: Lorah Perlee from Regeneron in a Riveting Dialogue Exchange with PharmaShots

Regeneron and Sanofi Receive the US FDA’s Approval for Dupixent to Treat Bullous Pemphigoid

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