Policy & Regulation
Trastuzumab Deruxtecan Recommended for Approval in the EU by CHMP for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen
29 June 2022 - - Japan-based pharmaceutical company Daiichi Sankyo (TSX: 4568) and British-Swedish multinational pharmaceutical and biotechnology company AstraZeneca's (LSE: AZN) (STO: AZN) ...
SwanBio Presents Design of Innovative Natural History Study Aimed to Evolve Understanding of Adrenomyeloneuropathy and Inform Future Treatments
29 June 2022 - - US-based gene therapy company SwanBio Therapeutics presented details about the company's ongoing natural history study of adrenomyeloneuropathy at the 8th Congress of the Eu...
Lynparza Receives Positive Opinion from EU CHMP as Adjuvant Treatment for Germline BRCA-Mutated, HER2-Negative High-Risk Early Breast Cancer
29 June 2022 - - The European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Lynparza for the adjuvant treatment of pati...
First Two Patients Dosed in Phase 1b/2a Study of BX004 for Treatment of Chronic Respiratory Infections in Patients with Cystic Fibrosis
29 June 2022 - - The first two patients have been dosed in US-based clinical-stage microbiome company BiomX Inc's (NYSE American: PHGE) Phase 1b/2a study evaluating BX004 for the treatment of chr...
US FDA Approves Prestige Biopharma's IND for Phase 1/2a Trial of First-in-Class Pancreatic Cancer Treatment, PBP1510
29 June 2022 - - The US Food and Drug Administration has approved the Phase 1/2a clinical trial of Singapore-based biopharmaceutical company Prestige Biopharma Ltd's first-in-class anti-PAUF mono...
Bayer opens new research centre in Boston-Cambridge
29 June 2022 - German multinational pharmaceutical and life sciences company Bayer AG (ETR:BAYN) has opened a new Research and Innovation Center in the United States, the company announced on Wednesda...