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NEWS

C4 Therapeutics and Roche Enter Oncology Collaboration Worth Over $1B to Develop DAC with Payload

Shots: C4 has entered into a new collaboration with Roche to develop degrader-antibody conjugates (DACs), combining targeted protein degradation with ADCs for cancer treatment Partnership will focus on two oncology programs against undisclosed targets, leveraging C4’ Torpedo platform for degrader payloads, while Roche will select & design the antibodies, conjugate them to payloads, & lead…
13 hours ago

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NEWS

Nuvalent Reports the US FDA’s NDA Submission for Neladalkib to Treat ALK-Positive NSCLC

Shots: The US FDA has received the NDA of neladalkib for the treatment of TKI pre-treated pts with advanced ALK-positive NSCLC NDA was supported by global P-I/II (ALKOVE-1) trial of neladalkib in TKI-pretreated advanced ALK-positive NSCLC, showing favorable activity incl. intracranial responses, targeting key progression drivers, & a generally well-tolerated safety profile; data to be…
2 days ago

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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…
2 days ago

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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
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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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