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Merck, Astellas and Pfizer Report the US FDA Approval of Perioperative Padcev + Keytruda for Cisplatin-Eligible MIBC Patients

Shots: The US FDA has approved Padcev (enfortumab vedotin) + Keytruda/Keytruda Qlex for neoadj. & adj. treatment for pts with muscle-invasive bladder cancer (MIBC), regardless of cisplatin eligibility Approval was supported by the P-III (EV-304/KEYNOTE-B15) trial assessing neoadj. Padcev + Keytruda, followed by surgery & then adj. Keytruda + Padcev vs neoadj. SoC + surgery in cisplatin-eligible MIBC…
July 13, 2026

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Hansoh Reports P-III (ARTEMIS-008) Trial Data on Risvutatug Rezetecan for Advanced or Relapsed SCLC

Shots: Hansoh has reported the P-III (ARTEMIS-008) trial results assessing risvutatug rezetecan (Ris-Rez/HS-20093) vs topotecan in pts with advanced or relapsed SCLC after prior Pt-based therapy Trial met its 1EP of improved OS in the interim analysis, with consistent benefit also observed across 2EPs, incl. PFS; data will be presented at an upcoming conference Based on…
July 10, 2026

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Viz.ai Partners with Cortechs.ai to Expand AI Platform into Neurodegenerative Disease Care

Shots: Viz.ai has partnered with Cortechs.ai to integrate its NeuroQuant & NeuroQuant MS into its AI-powered care coordination platform, expanding into neurodegenerative diseases The collaboration will initially focus on multiple sclerosis by integrating Cortechs.ai’s quantitative MRI analysis into Viz.ai’s clinical workflow & care coordination platform to improve MS identification, characterization, & management The company plans…
July 10, 2026

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Nanjing Leads Biolabs Receives NMPA Priority Review for Opamtistomig to Treat EP-NEC

Shots: The Chinese NMPA has accepted the BLA & granted priority review to Opamtistomig (LBL-024) as a monotx. for the treatment of advanced extrapulmonary neuroendocrine carcinoma (EP-NEC) BLA was supported by the registrational trial data, designed to assess the efficacy & safety of Opamtistomig in pts with advanced EP-NEC whose disease had progressed following ≥2…
July 10, 2026

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Rani Therapeutics Partners with PegBio to Expand Obesity Pipeline Across Multiple Novel Candidates

Shots: Rani Therapeutics has entered into a research and development collaboration with PegBio to evaluate delivery of multiple obesity & metabolic disease candidates using its proprietary RaniPill platform As per the deal, Rani and PegBio will collaborate on the preclinical development of RaniPill formulations for selected obesity & metabolic disease candidates, aiming to advance the…
July 10, 2026

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NEWS

Polpharma and Teva Sign Exclusive Licensing Deal for a Biosimilar Candidate to Ocrevus

Shots: Polpharma has granted Teva exclusive rights to commercialize both IV & SC formulations of Polpharma’s proposed biosimilar to Ocrevus (ocrelizumab) for multiple sclerosis, upon regulatory approval As per the deal, Polpharma will lead biosimilar development & manufacturing, while Teva will oversee regulatory filings & commercialization across the US, EU, Brazil, Canada, Australia, New Zealand,…
July 10, 2026

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CervoMed Completes Patient Enrollment in P-IIa Study of Neflamapimod for Nonfluent Variant Primary Progressive Aphasia

Shots: CervoMed has completed enrollment in the P-IIa study of neflamapimod for the treatment of nonfluent variant primary progressive aphasia (nfvPPA), a type of frontotemporal dementia, with interim results to be presented at CTAD 2026 The study will evaluate the safety, PK, & clinical effects of neflamapimod (40mg, PO, TID; n=19 and 80mg, BID; n=6)…
July 9, 2026

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Ipsen Pharmaceuticals
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Ipsen Reports Topline P-III (BEOND) Trial Program Data on Dysport in Both Episodic and Chronic Migraine

Shots: Ipsen has reported topline P-III (E-BEOND & C-BEOND) trial results assessing Dysport (abobotulinumtoxinA) vs PBO in a total of 1,510 adults with episodic & chronic migraine, respectively Both trials met their 1EP, with a reduction in monthly migraine days vs PBO & demonstrated a favorable safety profile; detailed results will be presented at a future…
July 9, 2026

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