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NEWS

ModeX Therapeutics (OPKO Health) Enters $1B+ Deal with Regeneron to Develop Multispecific Antibodies for Select Therapeutic Indications

Shots: ModeX & Regeneron entered into a license & collaboration agreement to develop multispecific antibodies across cancer and metabolic, combining ModeX’s MSTAR platform with Regeneron’s antibody binders Regeneron will fund & lead all development & commercialization in exchange for $7M upfront, plus future product selection, clinical, regulatory, & commercial milestones over $200M per molecule, with…
October 30, 2025

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Regeneron New
NEWS

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 & radiation Opinion 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…
October 21, 2025

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Regeneron New
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 H1’26 Approval was based on the P-III (C-POST) trial assessing Libtayo adj. (350mg, IV, Q3W for first 12wks.…
October 9, 2025

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Regeneron New
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 discussions Trial met its 1EP of improved MG-ADL total score, showing…
August 27, 2025

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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…
August 21, 2025

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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…
July 2, 2025

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