Results from the VALENTINE-PTCL01 phase 2 trial of Daiichi Sankyo’s EZHARMIA® (valemetostat tosilate) showed clinically meaningful and durable responses in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The data were presented in an oral session at the 2023…
Roche announced that the primary analysis of the Phase III HAVEN 7 study reinforced the efficacy and safety of Hemlibra® (emicizumab) in previously untreated or minimally treated infants with severe haemophilia A without factor VIII inhibitors. Results showed that Hemlibra…
Genmab and AbbVie announced new data from the ongoing phase 1/2 EPCORE™ NHL-1 clinical trial investigating epcoritamab (DuoBody® CD3xCD20), a T-cell engaging bispecific antibody administered subcutaneously, demonstrated an overall response rate (ORR) of 82 percent, a complete response (CR) rate…
Vertex Pharmaceuticals Incorporated and CRISPR Therapeutics announced today that FDA has approved CASGEVY™ (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 genome-edited cell therapy, for the treatment of sickle cell disease (SCD) in patients 12 years and older with recurrent vaso-occlusive crises (VOCs).…
Roche announced positive long-term follow-up data from the pivotal, phase III KATHERINE study in people with HER2-positive early-stage breast cancer (eBC) who have residual invasive disease following neoadjuvant (before surgery) treatment. “We are pleased that Kadcyla could offer people with…
Astellas Pharma announced that the European Commission (EC) on December 7 approved VEOZATM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, also known as hot flashes and/or night sweats,…
Novartis today announced that FDA approved Fabhalta® (iptacopan) as the first oral monotherapy for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). Fabhalta is a Factor B inhibitor that acts proximally in the alternative complement pathway of the immune…
Bristol Myers Squibb K.K. announced that the company has received manufacturing and marketing approval of the supplemental New Drug Application for an additional indication for Abecma®, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for patients…
AbbVie and Cerevel Therapeutics announced a definitive agreement under which AbbVie will acquire Cerevel Therapeutics and its robust neuroscience pipeline of multiple clinical-stage and preclinical candidates with potential across several diseases including schizophrenia, Parkinson’s disease (PD), and mood disorders. The…
Merck Group today launched its AIDDISON™ drug discovery software, the first software-as-a-service platform that bridges the gap between virtual molecule design and real-world manufacturability through SynthiaTM retrosynthesis software application programing interface (API) integration. It combines generative AI, machine learning and…