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NEWS

Pfizer Expands into Obesity Treatments with ~$7.3B Metsera Acquisition 
Shots: Pfizer has entered into a definitive agreement to acquire Metsera, expanding to obesity & cardiometabolic market As per the deal, Metsera will receive $47.5/share, representing an enterprise value of ~$4.9B, plus a non-transferable CVR of ~$22.50/share tied to milestones: $5 on P-III start of MET-097i + MET-233i, $7 on FDA approval for MET-097i monotx.,…
Merck
Merck’s Keytruda Qlex Receives the US FDA’s Approval for Subcutaneous Use Across 38 Solid Tumor Indications for Keytruda
Shots: The US FDA has approved Keytruda Qlex (pembrolizumab & berahyaluronidase alfa-pmph) for subcutaneous dosing in adults across 38 approved indications of Keytruda, with US availability expected by late Sep 2025 Approval was based on P-III (3475A-D77) trial assessing Keytruda Qlex (790mg/9600 units, Q6W) + Pt doublet CT vs IV Keytruda (400mg, Q6W) + Pt doublet CT…
Alkem Laboratories launches Pertuza (Biosimilar, Perjeta) Across India for Treating HER2-Positive Breast Cancer 
Shots:  Alkem Laboratories has launched Pertuza 420mg/14mL, a Perjeta biosimilar, across India for treating HER2-positive breast cancer   In a P-III trial, Pertuza showed equivalent efficacy, safety, and immunogenicity to the reference product   Pertuzumab is a HER2/neu receptor antagonist that was approved for HER2-positive breast cancer  Ref: Alkem Laboratories | Image: Alkem Laboratories | Press Release Related News:- CuraTeQ Biologics Reports…
Medtronic’s Altaviva Device Receives the US FDA’s Approval to Treat Urge Urinary Incontinence
Shots: The US FDA has approved the Altaviva device, an implantable tibial neuromodulation therapy to treat urge urinary incontinence Altaviva device is placed under the skin above the fascia & near the ankle in a minimally invasive, sedation & imaging-free procedure to restore bladder–brain communication & improve bladder control by delivering electrical impulses to the tibial…
Henlius & Organon
Henlius and Organon Receive the EC’s Approval for Bildyos & Bilprevda (Biosimilars, Prolia & Xgeva)
Shots: The EC has approved Bildyos (60mg/mL) & Bilprevda (120mg/1.7mL), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) for all indications of the reference product Approval was based on extensive clinical data, incl. analytical, PK & clinical studies, which showed comparable immunogenicity, efficacy & safety of Bildyos & Bilprevda to reference denosumab In 2022, Henlius…
Avant Technologies and Austrianova Form Joint Venture Klothonova to Develop Klotho-Based Cell Therapies
Shots: Avant Technologies and Austrianova signed a joint venture and licensing agreement to form Klothonova, a 50/50 Nevada-based Joint Venture focused on developing cell-based therapies using encapsulated Klotho-producing cells Under the terms of the agreement, Klothonova will leverage Austrianova’s proprietary cell-encapsulation technology to develop and commercialize therapies for Alzheimer’s disease, heart disease, cancer, kidney disease,…