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Biocon Receives Health Canada Approval for Bosaya and Vevzuo (Biosimilars, Prolia and Xgeva)
Shots: Health Canada has granted NOC to Biocon's Bosaya (60mg/mL, SC, PFS) & Vevzuo (70mg/mL, SC, single-dose vial), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) Approval was based on extensive data, incl. analytical, nonclinical, & clinical data, showing that both biosimilars matched the reference product in quality, safety & efficacy Bosaya & Vevzuo are anti-RANKL monoclonal…
Astellas and Pfizer Gain FDA Priority Review for Padcev + Keytruda in Muscle-Invasive Bladder Cancer (MIBC), Regardless of Cisplatin Eligibility
Shots: The US FDA has accepted sBLA & granted priority review to perioperative Padcev + Keytruda/Keytruda Qlex for the treatment of pts with MIBC, regardless of cisplatin eligibility (PDUFA: Aug 17, 2026) sBLA was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs…
TJ Biopharma Licenses Felzartamab to Biogen for Greater China in ~$850M Deal
Shots: TJ Bio has granted Biogen exclusive rights to felzartamab in Greater China, giving Biogen full global ownership as the drug advances through P-III trials across multiple immune-mediated diseases As per the deal, TJ Bio will receive $100M upfront, with ~$750M in commercial & sales milestones, plus mid-single to low-double-digit % of royalties on Greater…
Eli Lilly to Acquire Kelonia Therapeutics for ~$7B
Shots: Eli Lilly has entered into a definitive agreement to acquire Kelonia Therapeutics, expanding Lilly’s genetic medicine capabilities As per the deal, Lilly will acquire Kelonia for ~$7B in cash, incl. $3.25B upfront, & additional clinical, regulatory & commercial milestone payments; closing expected in H2’26 Acquisition will add Kelonia’s in vivo gene placement system (iGPS0) & its lead asset, KLN-1010, a one-time IV…
Pheast Therapeutics Reports Early P-Ia Data for PHST001 at AACR 2026
Shots: Pheast Therapeutics presented initial P-Ia data for PHST001 at AACR Annual Meeting 2026, demonstrating target engagement, innate immune activation, and early clinical activity PHST001 (anti-CD24 macrophage checkpoint inhibitor) was generally well tolerated, across dose-escalation cohorts and early signals of clinical activity were observed incl. tumor shrinkage and disease stabilization Preclinical data showed enhanced tumor…