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Dyne Therapeutics Receives FDA Orphan Drug Designation for DYNE-101 for the Treatment of Myotonic Dystrophy Type 1
On Track to Report Initial Data from the Global, Multiple Ascending Dose Phase 1/2 ACHIEVE Clinical Trial in the Second Half of 2023
European Commission approves Otsuka and Astex’s oral Inaqovi for AML
Co-developed by Japan-based Otsuka and British Astex, Inaqovi has been cleared by EC as monotherapy in AML patients who are ineligible for a standard induction chemotherapy
BeiGene regains worldwide rights from Novartis for Tevimbra
Tevimbra is a humanised IgG4 anti-PD-1 monoclonal antibody designed to lower binding to Fc-gamma (Fcγ) receptors on macrophages, supporting the body’s immune cells to detect and fight tumours
Rhythm Pharmaceuticals Receives Orphan Drug Designation from European Medicines Agency for Setmelanotide for Treatment of Acquired Hypothalamic Obesity
Rhythm is evaluating setmelanotide in a global Phase 3 clinical trial in acquired hypothalamic obesity and expects to complete patient enrollment in the fourth quarter of 2023
FDA Accepts for Priority Review Merck’s Supplemental New Drug Application for WELIREG in Certain Previously Treated Patients With Advanced RCC
Acceptance based on results from the Phase 3 LITESPARK-005 trial, which showed a statistically significant and clinically meaningful improvement in progression-free survival compared to everolimus in patients with advanced RCC that progressed following PD-1/L1 and VEGF-TKI therapies
Nephron Pharmaceuticals raises $350m to support future growth
The US-based firm will use the investment to fund its future growth in the production of manufactures safe, affordable generic inhalation medicines and suspensions
US FDA approves GSK’s Ojjaara for myelofibrosis patients with anaemia
The approval was based on the findings from the MOMENTUM study and a subpopulation of anaemia patients from the SIMPLIFY-1 Phase 3 trial which showed statistically significant improvement in constitutional symptoms, splenic response, and transfusion independence in patients
Precision BioLogic’s Factor VIII Deficient Plasma with VWF Now FDA-Cleared for Sale in US
CRYOcheck Factor VIII Deficient Plasma with VWF is intended for use in clinical laboratories to identify factor VIII (FVIII) deficiency in human plasma and aid in the management of hemophilia A
EMA CHMP backs Moderna’s updated Covid shot for authorisation in EU
Following the CHMP’s positive opinion, the European Commission will decide whether to approve the modified Covid-19 vaccine from Moderna for use in the fall/winter of 2023
SOPHiA GENETICS, Laboratorio Curie partner for BRCA gene mutations detection
Under the partnership, Laboratorio Curie will use the SOPHiA DDM Platform technology to deploy a new test for BRCA gene mutations identification to assist Paraguay’s expanding use of precision medicine