Watch Silke Gillessen give her thoughts on the CONTACT-02 trial of cabozantinib plus atezolizumab for mCRPC, presented at ESMO 2024.
Genentech is paying $850 million upfront for Regor Pharmaceuticals’ portfolio of CDK inhibitors, taking ownership of a breast cancer candidate that has shown signs of single-agent efficacy in patients failed by existing options
Bayer AG and BlueRock Therapeutics LP, a clinical stage cell therapy company and wholly owned independently operated subsidiary of Bayer AG today announced positive 24-month data from exPDite, a Phase 1 clinical trial of bemdaneprocel, an investigational cell therapy for the treatment of Parkinson's disease.
AstraZeneca’s Tagrisso (osimertinib) has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT)
Background and purpose: Two novel enzyme replacement therapies (ERTs), studied in phase 3 trials in late-onset Pompe patients, reached marketing authorization by the European Medicines Agency in 2022 and 2023. The European Pompe Consortium (EPOC) updates and extends the scope of the 2017 recommendations for starting, switching and stopping ERT.
IntraBio Inc., a leader in the discovery and development of innovative drugs for rare neurodegenerative diseases, announced that the FDA has approved Aqneursa (levacetylleucine) for the treatment of neurological manifestations of Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing greater than 15 kg. Aqneursa is the only FDA-approved stand-alone therapy indicated for the treatment of NPC.
Johnson & Johnson announced it is discontinuing the Phase II field study (NCT05201794) evaluating the efficacy of investigational antiviral candidate mosnodenvir for the prevention of dengue virus in adults aged 18-65 years
GSK plc announced new data from the AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial evaluating the efficacy of a single dose of Arexvy (respiratory syncytial virus vaccine, recombinant adjuvanted) against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 60 years and older, including those at increased risk over three full RSV seasons (NCT04886596)
The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 11 to 1 with 1 abstention against the risk:benefit profile of anti–PD-1 antibodies in the first-line treatment of patients with metastatic or unresectable esophageal squamous cell carcinoma (ESCC) with a PD-L1 expression of less than 1.1 The vote was preceded by a discussion of the following question: DISCUSSION: FDA would like the committee to discuss the risk and benefits of the treatment with anti PD-1 antibodies for the first line treatment of patients with metastatic or unresectable esophageal squamous cell carcinoma with PD-L1 expression < 1.2 “I voted no,” Christopher Lieu, MD, of The University of Colorado in Aurora, stated after the vote
UCB, announced the first presentation of two-year data from the Phase III studies, BE HEARD I and BE HEARD II, and their open-label extension, evaluating the efficacy and safety of bimekizumab, an IL-17A and IL-17F inhibitor, in adults with moderate to severe hidradenitis suppurativa (HS)