Industry News

Inovio Pharmaceuticals, Inc. announced that Inovio and its collaborators have published results in Nature Partner Journals (npj) Vaccines demonstrating that its Zika DNA vaccine (GLS-5700) protected animals from infection, brain damage and death. In this study 100% of GLS-5700 vaccinated animals were protected from Zika infection after exposure to the virus. In addition, vaccinated mice were protected from degeneration in the cerebral cortex and hippocampal areas of the brain while unvaccinated mice showed significant degeneration of the brain after Zika infection.

Silicon Valley medical device innovator CapsoVision, Inc. is pleased to announce that they have received U.S. Food and Drug Administration (FDA) 510(k) clearance for the CapsoCam® Plus small bowel capsule endoscope system.

Bristol-Myers Squibb Company  announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo (nivolumab) injection, for intravenous use, for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy. Opdivo is the first and only Immuno-Oncology treatment proven in a Phase 3 trial to significantly extend overall survival (OS) for these patients. In oncology clinical trials, OS is considered the gold standard primary endpoint to evaluate the outcome of any therapy.

Gilead Sciences, Inc. announced that the US Food and Drug Administration (FDA) has approved Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.

Roche announced positive results from the phase III GiACTA study, which evaluated Actemra®/RoActemra® (tocilizumab) in people with giant cell arteritis (GCA). GiACTA met its primary and key secondary endpoint, demonstrating that Actemra/RoActemra – initially in combination with a six month steroid (glucocorticoid) taper – enabled significantly more patients to achieve sustained disease remission while also significantly reducing steroid exposure compared with steroids alone.¹ Data results will be presented in an oral session on Sunday, 13 November at the 2016 American College of Rheumatology (ACR) and Association for Rheumatology Health Professionals (ARHP) Annual Meeting.

Bristol-Myers Squibb Company  announced that the company has entered into a five-year research collaboration with the Johns Hopkins University. The collaboration is designed to identify mechanisms of response and resistance in patients whose cancer is being treated with checkpoint inhibitor-based immunotherapies, including Opdivo (nivolumab) monotherapy, or Opdivo in combination with Yervoy (ipilimumab) or other investigational immunotherapies.

[adsense:336x280:8701650588]

Bristol-Myers Squibb Company and Pfizer Inc.  announced  that 12 Eliquis abstracts will be presented at the AHA Scientific Sessions 2016, to be held November 12-16 in New Orleans. Among these abstracts, the Bristol Myers-Squibb and Pfizer Alliance will present final data from the randomized AEGEAN (Assessment of an Educational and Guidance Program for Eliquis Adherence in Nonvalvular Atrial Fibrillation) study, highlighting adherence and persistence data for nonvalvular atrial fibrillation (NVAF) patients treated with Eliquis to reduce the risk of stroke.

Seattle Genetics  Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to ADCETRIS (brentuximab vedotin) for the treatment of patients with CD30-expressing mycosis fungoides (MF) and primary cutaneous anaplastic large cell lymphoma (pcALCL) who require systemic therapy and have received one prior systemic therapy. MF and pcALCL are the most common subtypes of cutaneous T-cell lymphoma (CTCL), accounting for more than 75 percent of the disease.

RedHill Biopharma Ltd. announced that it has concluded a positive Type B Meeting with the U.S. Food and Drug Administration (FDA) discussing the chemistry, manufacturing and controls (CMC) aspects of the RHB-105 Phase III development program. RHB-105 is a proprietary, fixed-dose, oral combination therapy for the eradication of H. pylori infection.
Subject to final minutes of the meeting, the FDA has accepted RedHill's manufacturing plan towards filing the CMC package as part of a potential U.S. New Drug Application (NDA) to be submitted for RHB-105, subject to successful completion of the planned confirmatory Phase III study.

Bristol-Myers Squibb Company and Infinity Pharmaceuticals, Inc. announced a clinical trial collaboration to evaluate Bristol-Myers Squibb’s Opdivo in combination with Infinity’s IPI-549 in patients with advanced solid tumours. The dose-escalation portion exploring IPI-549 as a monotherapy in Infinity’s phase 1 study is continuing, and the first dose-escalation cohort studying IPI-549 in combination with Opdivo, a PD-1 immune checkpoint inhibitor, is expected to begin this fall.