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Teva and Alvotech

Alvotech and Teva Enter into an Agreement with Regeneron to Launch AVT06 (Biosimilar, Eylea) Across US  

Shots:  Alvotech and Teva reached a settlement and license agreement with Regeneron, allowing the US launch of AVT06, a biosimilar version of Eylea (aflibercept) in Q4’26 or earlier under certain conditions   AVT06 is an aflibercept (Eylea) biosimilar that inhibits VEGF and has been approved as Mynzepli in the UK and EEA and as Aflibercept BS in Japan   On…

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Biocon Biologics Inks Settlement and Licensing Deal with Regeneron and Bayer for Worldwide Commercialization of Yesafili (Biosimilar, Eylea) 

Shots:  Biocon Biologics has signed a settlement and license agreement with Regeneron and Bayer for Yesafili (Biosimilar, Eylea) in the EU and globally, following a prior US and Canada settlement  Biocon Biologics, Regeneron, and Bayer settled all pending litigation, allowing Yesafili’s UK launch in Jan’26 and other countries by Mar’26 or earlier. YESAFILI launched in Canada in 2024, and US market entry secured in April…

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A New Era for Myeloma Patients: Regeneron’s Karen Rodriguez Lorenc on Lynozyfic’s Rising Global Impact 

Shots:  Lynozyfic is emerging as a standout in heavily pre-treated multiple myeloma. In the pivotal LINKER-MM1 trial, it delivered early, deep, and durable responses, offering renewed hope for patients with limited options. Its response-adapted dosing regimen further reduces treatment burden and enhances convenience  Regeneron is accelerating progress with a broad development strategy, advancing Lynozyfic across multiple therapy lines, combination regimens, precursor conditions, and global markets. The program…

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Regeneron and Tessera Therapeutics Enter ~$275M Collaboration to Advance TSRA-196 for Alpha-1 Antitrypsin Deficiency (AATD)

Shots: Regeneron has entered into a global collaboration with Tessera Therapeutics to develop & commercialize TSRA-196 as a one-time gene editing treatment of AATD As per the deal, Tessera & Regeneron will equally share global development costs & potential future profits for TSRA-196. Tessera will receive $150M in upfront & equity investment plus $125M in near…

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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…

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Regeneron New

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…

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Regeneron New

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.…

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Regeneron New

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…

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