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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…
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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…
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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…
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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,…
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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,…
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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…
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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…
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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…
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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’…
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MS Pharma has signed a strategic partnership with Hetero to localize five established biosimilars across key areas, including oncology, immunology, and hematology, in the MENA region
The exclusive agreement will be implemented through El Kendi (MS Pharma Group’s Algeria affiliate) and Hetero Biopharma, a subsidiary of Hetero Group
This marks Hetero’s first local partnership in Algeria, supporting…

