All The Most Important Pharmaceutical News Stories Of The Week – July 2018 – Week #3
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.
Anti-PD-L1 Immunotherapy Plus ABRAXANE® Significantly Reduced the Risk of Disease Worsening or Death in Patients with Metastatic or Locally Advanced Triple Negative Breast Cancer in Phase III IMpassion130 Study
July 11, 2018
Celgene Corporation has announced that the Phase III IMpassion130 study, which was sponsored by Roche, met its co-primary endpoint of progression-free survival (PFS). This is the first phase III study to demonstrate a statistically significant PFS improvement in first-line metastatic or unresectable locally advanced triple negative breast cancer (TNBC), a type of breast cancer with high unmet need. Results demonstrated that the investigational combination of TECENTRIQ® (atezolizumab) plus ABRAXANE® (paclitaxel) compared to ABRAXANE® monotherapy, as a first-line treatment, significantly reduced PFS in patients with metastatic or unresectable locally advanced TNBC in the ITT and PD-L1 positive populations.
July 11, 2018
Otsuka Pharmaceutical Co., Ltd. (Otsuka) and Visterra, Inc. (Visterra) announce that they have entered into a definitive merger agreement pursuant to which Otsuka will acquire Visterra for approximately USD 430 million in an all-cash transaction. The Otsuka and Visterra boards of directors have approved the transaction. Subject to customary closing conditions, including expiration or termination of the waiting period under U.S. antitrust laws, the transaction is expected to close in the third quarter of 2018.
Bristol-Myers Squibb’s Opdivo® (nivolumab) + Low-Dose Yervoy® (ipilimumab) is the First Immuno-Oncology Combination Approved for MSI-H/dMMR mCRC Patients Who Progressed Following Treatment with a Fluoropyrimidine, Oxaliplatin and Irinotecan
July 11, 2018
Bristol-Myers Squibb Company has announced has Opdivo (nivolumab) 3 mg/kg plus low-dose Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (mCRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan. Approval for this indication has been granted under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
July 12, 2018
Amgen and UCB have announced the resubmission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for EVENITY™ (romosozumab), an investigational monoclonal antibody for the treatment of osteoporosis in postmenopausal women at high risk for fracture. EVENITY increases bone formation and reduces bone resorption simultaneously to increase bone mineral density (BMD) and reduce the risk of fracture.
Genmab Enters Strategic Partnership with Immatics to Discover and Develop Next Generation Bispecific Cancer Immunotherapies
July 12, 2018
Genmab A/S has announced that it has entered into a research collaboration and exclusive license agreement with privately owned Immatics Biotechnologies GmbH (Immatics), to discover and develop next-generation bispecific immunotherapies to target multiple cancer indications. The deal strengthens Genmab’s position in immuno-oncology by combining Genmab’s proprietary technologies and antibody know-how with Immatics’ XPRESIDENT® targets and T-cell receptor (TCR) capabilities. Genmab will receive an exclusive license to three proprietary targets from Immatics, with an option to license up to two additional targets at predetermined economics. The companies will conduct joint research, funded by Genmab, on multiple antibody and/or TCR-based bispecific therapeutic product concepts.
Advaxis Announces FDA Lifts Clinical Hold on Phase 1/2 Combination Study of Axalimogene Filolisbac With Durvalumab
July 13, 2018
Advaxis, Inc., a late-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, has announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Company’s Investigational New Drug (IND) application for its Phase 1/2 study of axalimogene filolisbac (AXAL) in combination with durvalumab for the treatment of patients with advanced, recurrent or refractory cervical cancer and HPV-associated head and neck cancer.
U.S. FDA Approves Xtandi® (Enzalutamide) for the Treatment of Men with Non-Metastatic Castration-Resistant Prostate Cancer (CRPC)
July 13, 2018
Astellas Pharma Inc. and Pfizer Inc. have announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide), following FDA Priority Review designation, based on results from the Phase 3 PROSPER trial. The FDA action broadens the indication for XTANDI to men with castration-resistant prostate cancer (CRPC), now including men with non-metastatic CRPC. This approval makes XTANDI the first and only oral medication FDA-approved for both non-metastatic and metastatic CRPC. XTANDI was first approved by the FDA in 2012 for the treatment of patients with metastatic CRPC who had previously received docetaxel and was granted approval in 2014 for chemotherapy-naïve men with metastatic CRPC.
July 16, 2018
Pfizer Inc. and Spark Therapeutics have announced that Pfizer initiated a Phase 3 open-label, multi-center, lead-in study (NCT03587116) to evaluate the efficacy and safety of current factor IX prophylaxis replacement therapy in the usual care setting. The factor IX prophylaxis efficacy data obtained in the lead-in study will serve as the within-subject control group for those patients that enroll into the next part of the Phase 3 study, which will evaluate the investigational gene therapy fidanacogene elaparvovec for the treatment of hemophilia B. The interventional portion of this pivotal Phase 3 study will enroll patients who have completed at least six months in the lead-in study. Fidanacogene elaparvovec is the official United States Adopted Name (USAN) and will become the Recommended International Nonproprietary Name (INN) for the therapy formerly known as SPK-9001 and PF-06838435.Top Pharma News of the Week – July 16th last edit: 2018-07-17T17:15:48+00:00 da