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INSIGHTS+

Key Biosimilars Events of March 2026 

Shots:  Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.  Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…
3 days ago

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NEWS

Novartis to Acquire Excellergy for ~$2B

Shots: Novartis has entered into an agreement to acquire Excellergy, incl. its asset Exl-111, strengthening Novartis immunology strategy in food allergy & other IgE-driven diseases  As per the deal, Novartis will acquire Excellergy for ~$2B, incl. upfront & milestone payments, with closing expected in H2’26 EXL-111 is engineered to dissociate receptor-bound IgE, enabling faster &…
March 27, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in February 2026    

Shots:  The European Commission approved multiple innovative therapies across vaccines, oncology, cardiology, immunology, and rare diseases, including products from Moderna, Hansoh Pharmaceutical, Cytokinetics, ImmunityBio, and GSK  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from Ipsen, X4 Pharmaceuticals, Novartis, and Moderna, alongside additional recommendations for therapies targeting chronic spontaneous urticaria, WHIM syndrome, pediatric…
March 17, 2026

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NEWS

Novartis Reports the US FDA Approval of Cosentyx for Pediatric Patients with Hidradenitis Suppurativa

Shots: The US FDA has approved Cosentyx(secukinumab) for the treatment of pts (≥12yrs., ≥30kg) with mod. to sev. hidradenitis suppurativa Approval was supported by adult clinical studies, PK modeling extrapolated from adult HS & psoriasis trials, pediatric trial data from other approved indications, & dosing analyses that showed weight-based pediatric dosing achieves exposure comparable to…
March 16, 2026

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NEWS

GSK to Acquire 35Pharma for $950M

Shots: GSK has entered into an agreement to acquire 35Pharma, incl. its asset HS235, expanding scalable growth opportunities within its Respiratory, Immunology & Inflammation portfolio As per the deal, GSK will acquire 100% of 35Pharma’s equity for $950M in cash, payable at closing HS235, a therapy targeting the activin receptor signalling pathway, has completed P-I…
February 25, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in January 2026    

Shots:  The European Commission approved multiple therapies across vaccines, rare diseases, endocrinology, and immunology, including products from BioNet, Sanofi, Fondazione Telethon, IntraBio, and Ionis / Otsuka.  The Committee for Medicinal Products for Human Use also issued positive opinions for late-stage assets from UCB and Gedeon Richter, with additional recommendations supporting Sanofi’s Rezurock.  Decisions were backed by strong Phase II/III data…
February 17, 2026

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NEWS

Memo Therapeutics and CSL Partner to Advance Recombinant Polyclonal IgG Technology

Shots: Memo has entered into a strategic collaboration & exclusive option-to-license agreement with CSL for Memo’s recombinant polyclonal IgG technology As per the deal, Memo will use its Dropzylla platform for cloning human antibody repertoires & polyclonal antibody expression to develop recombinant polyclonal IgG products, while CSL will obtain an option to exclusively license those…
February 9, 2026

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NEWS

Innovent and Eli Lilly Strike ~$8.85B ex-China Collaboration to Accelerate Oncology & Immunology Programs

Shots: Innovent & Eli Lilly have entered into a strategic collaboration to advance novel medicines in oncology & immunology As per the deal, Innovent will advance the programs from discovery through P-II PoC trial in China using its antibody platforms, while Lilly will receive exclusive rights to develop & commercialize the assets globally, excl. Greater…
February 9, 2026

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INSIGHTS+

Key Biosimilars Events of January 2026   

Shots:  Global biosimilar activity accelerated across ophthalmology, oncology, immunology, and diabetes, with new or advancing alternatives to Lucentis, Eylea, Stelara, Lantus, Avastin, Opdivo, and Neulasta, expanding patient access across Europe, the US, India, Canada, Ghana, and MENA  Regulatory and commercialization momentum remained strong, marked by FDA, EC, Health Canada, and Ghana FDA milestones, alongside Samsung Bioepis’…
February 3, 2026

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