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NEWS

Kymera Therapeutics Reports Gilead’s Option Exercise to License KT-200, a CDK2 Molecular Glue Degrader

Shots: Gilead Sciences has exercised its option to exclusively license KT-200, a first-in-class oral CDK2 molecular glue degrader, from Kymera Therapeutics under their existing collaboration The option exercise triggers a $45M milestone payment to Kymera; the company remains eligible for up to $750M in total payments, including milestones and tiered royalties on net sales Gilead…
53 minutes ago

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NEWS

Imagene AI Partners with Daiichi Sankyo to Advance Multimodal Biomarker Discovery in Oncology

Imagene AI has entered into a collaboration with Daiichi Sankyo to advance biomarker discovery and response prediction across oncology drug development programs Under the collaboration, Daiichi Sankyo will leverage Imagene’s OI Suite, powered by the CanvOI foundation model, to integrate H&E and IHC whole-slide images with molecular and clinical data to enhance biomarker identification and…
2 hours ago

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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…
20 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…
3 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
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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