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NEWS

Candel Therapeutics and RTW Enter Royalty Funding Agreement to Support the Launch Aglatimagene Besadenovec in Localized Prostate Cancer

Shots: Candel Therapeutics has entered into a $100M royalty funding agreement with RTW Investments, contingent on FDA approval of Aglatimagene Besadenovec (CAN-2409) for intermediate- to high-risk localized prostate cancer As per the deal, RTW will receive a capped, tiered single-digit percentage of US annual net sales of aglatimagene. Candel Plans to submit a BLA for…
February 20, 2026

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NEWS

NexEos Bio Receives US FDA IND Clearance to Advance NTX-1024 into P-II/III Study for Vernal Keratoconjunctivitis

Shots: The US FDA has cleared NexEos Bio’s IND application to initiate a P-II/III clinical study of NTX-1024 ophthalmic solution for the treatment of vernal keratoconjunctivitis (VKC) The P-II/III study will evaluate the safety and efficacy of NTX-1024 in VKC, following positive results from an open-label investigator-initiated study showing improvements in symptoms and ocular inflammation…
February 20, 2026

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NEWS

Zydus Lifesciences  Launches Anyra (Biosimilar, Eylea) in the Canada 

Shots:  Zydus Lifesciences has launched Anyra (aflibercept 2 mg), a biosimilar version of Eylea. Zydus has inked an agreement with Regeneron and Bayer  Aflibercept is a Vascular endothelial growth factor-A (VEGF-A) and placental growth factor (PlGF), which are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability…
February 19, 2026

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NEWS

Rezon Bio’s Warsaw-Duchnice facility Receives the US FDA Approval for Commercial Manufacturing 

Shots:  The US FDA grants approval for commercial manufacturing of a biosimilar at Rezon Bio’s Warsaw-Duchnice facility  The FDA approval of the Warsaw-Duchnice facility follows a comprehensive review process and indicates that the site meets regulatory standards for quality systems, technical capabilities, and operational readiness to supply the US market  This approval follows earlier EMA GMP certification and authorization for commercial…
February 18, 2026

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Sandoz
NEWS

Sandoz Reports the US FDA’s Approval of Enzeevu (Biosimilar, Eylea) 

Shots:  The US FDA has approved Enzeevu, a biosimilar version of Eylea (aflibercept), for multiple retinal indications, with an anticipated launch in Q4’26   Aflibercept is a recombinant fusion protein that blocks VEGF-A and PlGF, inhibiting abnormal blood vessel growth   Enzeevu (aflibercept-abzv) is approved for the treatment of patients with neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO),…
February 18, 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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Moderna
NEWS

Moderna Reports the EC Approval of mNEXSPIKE to Protect Against COVID-19 

Shots:  The EC has approved mNEXSPIKE (mRNA-1283), a COVID-19 vaccine, for active immunization against SARS-CoV-2 in individuals (aged≥12 yrs)   Approval was based on the P-III trial evaluating mNEXSPIKE (mRNA-1283; 10 µg) versus Spikevax (mRNA-1273; 50 µg) in ~11,400 participants (aged ≥12 yrs), with primary efficacy assessed from 14 days post-vaccination   mNEXSPIKE showed 9.3% superior relative vaccine efficacy (rVE) in subjects (≥12yrs.), whereas in a descriptive sub-group analysis mNEXSPIKE showed 13.5%…
February 12, 2026

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NEWS

Acrotech Biopharma and Otsuka Pharmaceutical Receive the US FDA Approval for Adquey to Treat Mild-to-Mod. Atopic Dermatitis 

Shots:  The US FDA has approved Adquey (difamilast 1%) ointment for treating mild-to-mod. atopic dermatitis in adults and children aged≥ 2 yrs.  Approval was based on multiple pivotal P-III trials, which showed a significantly higher proportion of patients treated with ADQUEY achieving IGA success after 4 wks vs vehicle, with a consistent safety profile  Adquey is a non-steroidal topical PDE-4 inhibitor for BID treatment…
February 12, 2026

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