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Japan’s Researchers Face Increased Ethics Oversight
Scientists in Japan applying for government grants will soon be getting new mandatory reading material: a manual for promoting research integrity. The manual is being developed by the country’s three major funding agencies and the Science Council of Japan, the nation’s largest organization of researchers. [ScienceInsider] Editorial
Australian Gene-Patent Case Dismissed
An Australian federal court has thrown out a lawsuit challenging a patent on the cancer-associated gene BRCA1. The decision is the latest setback for patient advocates who argue that the patent limits genetic-testing options for Australian cancer patients. [Nature News] Editorial
RIKEN to Investigate STAP Papers Yet Again
RIKEN announced a new investigation into two papers reporting a sensational but now-discredited way of making stem cells. A brief announcement on RIKEN’s website states that the committee will look into issues concerning the papers and related cell lines that have emerged since a previous committee probing for research misconduct completed its work. [ScienceInsider] Editorial
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| | | BUSINESS |
Ludwig Cancer Research and Cancer Research Institute Collaborate on Evaluation of VentiRx’s Investigational Immunotherapy
The nonprofits Ludwig Cancer Research and the Cancer Research Institute (CRI) announced an agreement with VentiRx Pharmaceuticals Inc. to conduct a clinical trial with motolimod (VTX-2337) combined with other immunotherapy agents available to Ludwig and CRI through other industry partnerships. [Ludwig Institute for Cancer Research Ltd.] Press Release
Allergopharma and S-TARget Therapeutics Conclude Licensing Agreement
Allergopharma, the Merck Allergy Business Unit, and S-TARget therapeutics have signed an exclusive licensing agreement. The main focus of this cooperation is the use of S-TARget S-TIR™ technology and the associated development of a new generation of products for the causal treatment of allergies. [Merck KGaA] Press Release
Merck Receives Accelerated Approval of KEYTRUDA® (Pembrolizumab), the First FDA-Approved Anti-PD-1 Therapy
Merck announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA® (pembrolizumab) at a dose of 2 mg/kg every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. [Merck & Co., Inc.] Press Release
Cynata Initiates European Regulatory Process
Cynata Therapeutics Ltd announced that it has formally initiated a Scientific Advice procedure with the European Medicines Agency (EMA). This important interaction represents the first step in formal engagement with the EMA, the body responsible for issuing therapeutic product approvals in the EU. [Cynata Therapeutics Ltd.]
Press Release
Advanced Cell Technology Announces Issuance of Patent Covering Dendritic Cells Manufacturing from Renewable Stem Cell Sources
Advanced Cell Technology, Inc. announced that the US Patent and Trademark Office has issued U.S. patent 8,822,218 covering methods of manufacturing dendritic cells using a highly scalable processing involving a readily renewable stem cell source as the starting materials. [Advanced Cell Technology, Inc.] Press Release
Amgen Submits Marketing Authorization Application for Talimogene Laherparepvec to the European Medicines Agency
Amgen announced the submission of a Marketing Authorization Application to the European Medicines Agency via the centralized procedure for talimogene laherparepvec seeking approval for the treatment of adults with melanoma that is regionally or distantly metastatic. Talimogene laherparepvec is an investigational oncolytic immunotherapy administered as an intralesional injection that is designed to initiate a systemic anti-tumor immune response. [Amgen Inc.] Press Release
Bristol-Myers Sues Merck over Cancer Immunotherapy Patent
Bristol-Myers Squibb Co. accused Merck & Co. of infringing a new U.S. patent for a novel method of cancer-fighting that uses a patient’s own immune system to fight the disease. [Bloomberg L.P.] Article
FDA Removes Partial Clinical Hold on OncoMed’s Ipafricept
OncoMed Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) removed the partial clinical hold on the company’s ipafricept Phase I clinical trials. Ipafricept (Fzd8-Fc, OMP-54F28) is a first-in-class fusion protein that inhibits a key signaling pathway in cancer, the Wnt pathway. [OncoMed Pharmaceuticals, Inc.] Press Release
Cellular Biomedicine Group Launches Clinical Research Study for Cartilage Defect Stem Cell Therapy
Cellular Biomedicine Group Inc. announced the launch of a study on human adipose derived mesenchymal progenitor cell therapy for cartilage defects resulting from osteoarthritis or sports injury. [Cellular Biomedicine Group Inc.] Press Release
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