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Amgen
NEWS

The CHMP Recommends Amgen’s Imdylltra to Treat 1L ES-SCLC   

Shots:  The CHMP has recommended Imdylltra (tarlatamab) as a monotx. to treat adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease relapsed during or after an initial treatment with Pt-based CT  Opinion was based on the P-III study in 509 ES-SCLC pts post Pt therapy, where Imdylltra showed improved mOS (13.6 vs 8.3 mos.; ~40% lower death risk) and higher mPFS (4.2 vs 3.2 mos.) vs SoC  Imdylltra is…
March 26, 2026

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Pfizer New
NEWS

Pfizer Reports P-III (TALAPRO-3) Trial Data on Talzenna Combination in HRR-Gene Mutated Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

Shots: Pfizer has reported P-III (TALAPRO-3) trial data assessing Talzenna (talazoparib; 0.5mg/day) + Xtandi (160mg/day) vs PBO + Xtandi in 599 pts with HRR gene-mutated mHSPC Trial met its 1EP, showing improved rPFS with a hazard ratio surpassing the pre-specified target of 0.63, as most pts remained progression-free; consistent benefit was observed across tumors with both…
March 19, 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

Servier to Acquire Day One Biopharmaceuticals for ~$2.5B

Shots: Servier has entered into a definitive agreement to acquire Day One Biopharmaceuticals As per the deal, Servier will acquire Day One for $21.5/share in cash, representing the total equity value of ~$2.5B, with remaining shares acquired later via a second-step merger; closing expected in Q2’26 Acquisition will strengthen Servier’s leadership in pediatric low-grade glioma…
March 9, 2026

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INSIGHTS+

Key Biosimilars Events of February 2026 

Shots:  Regulatory momentum accelerated globally with multiple biosimilars securing key approvals and positive opinions, including Sandoz’s Enzeevu (Eylea biosimilar) in the US and Canada, Accord BioPharma’s Filkri (Neupogen biosimilar) US FDA approval, EC approvals for Gotenfia (Simponi biosimilar) and Ranluspec (Lucentis biosimilar), and CHMP positive opinions for tocilizumab and insulin biosimilars.  Strategic partnerships expanded regional access as companies including Alvotech, Bio-Thera Solutions, Formycon,…
March 3, 2026

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Merck new
NEWS

Merck Carves Out Oncology as Standalone Division

Shots: Merck has reorganized its Human Health division into two units: Oncology, and Specialty, Pharma & Infectious Diseases, to sharpen commercial execution & support a growing portfolio of launches across diverse therapeutic areas Jannie Oosthuizen has been appointed EVP & President, Oncology & MSD International, while Brian Foard will serve as EVP & President, Specialty,…
February 24, 2026

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NEWS

Iambic Therapeutics Partners with Takeda to Advance AI-Driven Drug Discovery in Oncology and GI/Inflammation

Shots: Iambic has partnered with Takeda in a multi-year tech & discovery collaboration to utilize Iambic’s AI drug discovery models toward advancing select high-priority small molecule programs in Takeda’s Oncology, & GI & Inflammation therapeutic areas The collaboration will leverage Iambic’s AI drug discovery suite & wet lab capabilities, with Takeda also gaining access to…
February 10, 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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NEWS

Eisai and Henlius Partner to Commercialize Serplulimab in Japan

Shots: Eisai & Henlius have entered into an exclusive commercialization & co-exclusive development & manufacturing license agreement for serplulimab (Hetronifly in the EU) in Japan As per the deal, Eisai will obtain exclusive rights to commercialize serplulimab in Japan in exchange for $75M upfront, ~$80.01M in regulatory milestones, ~$233.3M in sales milestones, with double-digit royalties…
February 6, 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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