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ImmunoGen Announces European Medicines Agency Acceptance of Marketing Authorization Application for Mirvetuximab Soravtansine in Platinum-Resistant Ovarian Cancer
The MAA is supported by positive data from the Phase 3 MIRASOL trial of ELAHERE in platinum-resistant ovarian cancer, which was disclosed in May 2023
US CDC recommends Bavarian Nordic’s Jynneos vaccine for routine use in adults
The ACIP panel voted to recommend that 18 years and older individuals with certain risk factors should be administered a two-dose regimen of the vaccine
FDA approves Servier’s Tibsovo for R/R myelodysplastic syndromes
The approval was based on the data from the Phase 1, multicentre study of IDH1-mutated R/R MDS patients in which Tibsovo showed a complete remission rate of 38.9% and objective response rate of 83.3%
Templewater to buy OncoCare Medical and Novena Heart Centre in Singapore
OncoCare is a medical oncology clinic group with seven clinics at hospitals and medical centres whereas NHC is a multi-disciplinary cardiology group with three cardiology clinics in Singapore
EC outlines steps to address medicine shortages and strengthen supply security
The governing body has launched a European Voluntary Solidarity Mechanism, will create a union list of critical medicines, and has announced regulatory flexibilities
INVO Bioscience to acquire NAYA Biosciences to establish life science firm
The enlarged company after the subsequent merger is anticipated to operate under the name NAYA Biosciences and will focus on enhancing patient access to treatments in oncology, fertility, and regenerative medicine
Sumitomo Pharma’s Orgovyx gets Health Canada’s nod for prostate cancer
The approval is supported by the safety and efficacy data from the Phase 3 HERO trial of Orgovyx in which the drug met the primary endpoint
Certa Therapeutics’ FT011 Granted US FDA Orphan Drug Designation for the Treatment of Systemic Sclerosis
Certa previously announced positive top-line results from a Phase 2 study which indicated that treatment with FT011 for 12 weeks resulted in a clinically meaningful improvement
Mayo Clinic, Oxford Nanopore partner to develop novel clinical tests for cancer and genetic disorders
Within the framework of the collaboration, Mayo Clinic and Oxford Nanopore have identified several key areas of development, including translational research in human genetics and the detection of genetic predisposition to cancer
FDA Grants Fast Track Designation to ANPD001, Autologous Investigational Cell Therapy for the Treatment of Parkinson’s Disease
Aspen plans to initiate a first-in-patient Phase 1/2a clinical trial of ANPD001 for participants with moderate to severe PD