All The Most Important Pharmaceutical News Stories Of The Week – July 2018 – Week #2
FDA Grants Priority Review to Merck’s Supplemental Biologics License Application for KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy as First-Line Treatment for Metastatic Squamous Non-Small Cell Lung Cancer
July 2, 2018
Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with carboplatin-paclitaxel or nab-paclitaxel as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), regardless of PD-L1 expression. This sBLA, which is seeking accelerated approval for this new indication, is based on data from the Phase 3 KEYNOTE-407 trial, which were recently presented at the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting. The FDA has granted Priority Review to this sBLA and set a Prescription Drug User Fee Act (PDUFA), or target action, date of Oct. 30, 2018.
July 2, 2018
AstraZeneca and MedImmune, its global biologics research and development arm, have announced that the Japanese Ministry of Health, Labour and Welfare approved Imfinzi (durvalumab) as maintenance therapy after definitive chemoradiation therapy (CRT) in locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC).
Phase III IMpassion130 study showed Roche’s Tecentriq plus Abraxane significantly reduced the risk of disease worsening or death in people with metastatic triple negative breast cancer
July 2, 2018
Roche has announced that the Phase III IMpassion130 study met its co-primary endpoint of progression-free survival (PFS). Results demonstrated that the combination of Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]), as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in the intention-to treat and PD-L1 positive population with metastatic or unresectable locally advanced triple negative breast cancer (TNBC). Overall survival (OS) is encouraging in the PD-L1 positive population at this interim analysis and follow up will continue until the next planned analysis.
July 2, 2018
AstraZeneca and Merck, known as MSD outside the United States and Canada, have announced that Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has approved LYNPARZA® (olaparib) tablets for use in patients with unresectable or recurrent BRCA-mutated (BRCAm), human epidermal growth factor receptor 2 (HER2)-negative breast cancer who have received prior chemotherapy. Patients are selected for therapy based on an approved companion diagnostic.
July 3, 2018
Catalent, Inc., global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has announced that it has agreed to acquire Juniper Pharmaceuticals, Inc., including its Nottingham, U.K.-based Juniper Pharma Services division. When combined with Catalent’s existing industry-leading drug development and manufacturing capabilities in the U.S. and Europe, the acquisition of Juniper will expand and strengthen Catalent’s offerings in formulation development, bioavailability solutions and clinical-scale oral dose manufacturing, and will complement its integrated global clinical and commercial supply network.
July 05, 2018
Eisai Co., Ltd. and Biogen Inc. announced positive topline results from the Phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer’s disease. The study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer’s Disease Composite Score (ADCOMS) and on reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography).
Axovant Licenses Investigational Gene Therapy for Parkinson’s Disease from Oxford BioMedica and Announces Key Leadership Team Addition
June 6, 2018
Axovant Sciences has announced that it has licensed the exclusive worldwide rights to develop and commercialize OXB-102, now AXO-Lenti-PD, from Oxford BioMedica. AXO-Lenti-PD is an investigational gene therapy for Parkinson’s disease that delivers three genes encoding a critical set of enzymes required for dopamine synthesis in the brain. Oxford BioMedica is a world leader in lentiviral vector product development and manufacturing, and will be the clinical and commercial supplier of AXO-Lenti-PD. Axovant expects to initiate a Phase 1/2 dose escalation study of AXO-Lenti-PD in patients with advanced Parkinson’s disease by the end of 2018.
Axovant Announces Global Licensing Agreement for AXO-AAV-OPMD Program for Treatment of Oculopharyngeal Muscular Dystrophy and Broader Platform Collaboration with Benitec Biopharma
July 9, 2018
Axovant Sciences has announced that it has licensed exclusive global rights to an investigational Silence-and-Replace gene therapy program from Benitec Biopharma for the treatment of oculopharyngeal muscular dystrophy (OPMD) and has also entered into a research collaboration for the development of five additional gene therapy products in neurological disorders. The Silence-and-Replace gene therapy technology is designed to deliver a combination of DNA-directed RNA interference (silence) along with a functional copy of the gene (replace) in a single vector construct. This approach is applicable to various genetic diseases, including autosomal dominant disorders caused by nucleotide repeat expansion.
Celgene and Acceleron Announce Luspatercept Achieved Primary and All Key Secondary Endpoints in Phase III ‘BELIEVE’ Study in Adults with Transfusion-Dependent Beta-Thalassemia
July 9, 2018
Celgene Corporation and Acceleron Pharma Inc. have announced results from a phase III, randomized, double-blind, multi-center clinical study (BELIEVE). Luspatercept achieved a highly statistically significant improvement in the primary endpoint of erythroid response, which was defined as at least a 33 percent reduction from baseline in red blood cell (RBC) transfusion burden with a reduction of at least 2 units during the protocol-defined period of 12 consecutive weeks, from week 13 to week 24, compared to placebo.Top Pharma News of the Week – July 9th last edit: 2018-07-12T17:23:18+00:00 da