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Ascletis Pharma Reports First Patient Dosing with ASC30 in P-IIa Trial for Obese or Overweight Patients
Shots: Ascletis Pharma has dosed first participants with ASC30 (PO, QD) in its US P-IIa trial for obesity (BMI ≥30kg/m^2) or overweight pts (BMI ≥27kg/m^2 but <30kg/m^2) with ≥1 weight-related comorbidity Trial will assess 2 ASC30 formulations (tablets & tablets A1), with pts starting at 1mg & undergoing weekly titrations to maintenance doses of 20 or 40mg…
July 3, 20250Comments
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mAbxience Reports the EC’s Approval of Denbrayce and Izamby (Biosimilar, Xgeva and Prolia)
Shots: The EC has approved Denbrayce & Izamby, biosimilar versions of Amgen’s Xgeva & Prolia (denosumab) following the CHMP’s recommendation Denbrayce prevents skeletal-related events in adults with bone-involved malignancies & treats giant cell tumors of bone in adults & skeletally mature adolescents Izamby is indicated to treat osteoporosis in postmenopausal women & men at increased risk…
July 3, 20250Comments
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Neurizon Therapeutics Licenses Monepantel from Elanco Animal Health to Accelerate NUZ-001 Commercialization
Shots: Elanco has granted Neurizon exclusive global rights to monepantel’s data package & related IP to develop & commercialize NUZ-001 & related compounds for the treatment, prevention, or palliation of ALS & other neurodegenerative diseases in humans As per the deal, Elanco will receive an upfront payment, development milestone payments of $9.75M for the initial…
July 3, 20250Comments
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Dizal Receives the US FDA’s Accelerated Approval for Zegfrovy (Sunvozertinib) to Treat EGFRm NSCLC
Shots: The US FDA has granted accelerated approval to Zegfrovy for locally advanced or metastatic NSCLC associated with EGFR exon 20 insertion mutations (exon20ins) in pts whose disease has progressed on or after Pt-based CT Approval was based on the multinational WU-KONG1 part B trial assessing Zegfrovy in above mentioned pts, which showed significant improvement…
July 3, 20250Comments
VIEWPOINTS
Regeneron at ASH’24: Aafia Chaudhry in a Stimulating Dialogue Exchange with PharmaShots 
Shots:   Recently, Regeneron presented Odronextamab’s data in treating patients with different B-NHL subtypes (OLYMPIA studies) and marginal zone lymphoma (ELM-2 study)  Aafia Chaudhry, Vice President, Global Program Head for Hematology-Oncology at Regeneron, discusses Odronextamab’s ongoing studies as monotherapy and in combination to treat various malignancies  Aafia shares the upcoming PDUFA date on July 30th for…
July 2, 20250Comments
Vertex Pharmaceuticals
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Vertex Pharmaceuticals’ Alyftrek Receives the EC’s Approval to Treat Cystic Fibrosis
Shots:    The EC has approved Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat pts (≥6yrs.) with cystic fibrosis (CF), having ≥1 non-class I mutation in the CFTR gene; regulatory review is ongoing in Canada, Switzerland, Australia, & New Zealand In 2 H2H trials, Alyftrek + ivacaftor matched Kaftrio (ivacaftor/tezacaftor/elexacaftor) on ppFEV1 & showed superiority in reducing sweat chloride…
July 2, 20250Comments