-The worlds most progressive pharmaceutical companies, CROs and sites will continue to advance beyond the clinical trial status quo at the 2017 DrugDev Summit in Philadelphia, November 7-8. Co-chaired by Novartis and CSL Behring, DrugDevs annual Summit is widely regarded by customers as the premier open forum for sharing clinical trial best practic
Excluding specified items, adjusted diluted EPS from continuing operations was $0.66 in the third quarter, at the high end of the previous guidance range of $0.64 to $0.66. In September, Abbott received U.S. FDA approval for its FreeStyle Libre glucose monitoring system as a replacement1 for finger stick blood glucose monitoring. During the quarter
AcelRx Pharmaceuticals, Inc., a specialty pharmaceutical, today announced its clinical data presentation on the safety and efficacy of DSUVIA?, 30 mcg classified by age group across four clinical trials at the American Society of Anesthesiologists' ANESTHESIOLOGY 2017 Annual Meeting. The information presented during the session was authored
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, announced today that the results of the APOLLO Phase 3 study of patisiran in hereditary ATTR amyloidosis patients with polyneuropathy, as well as additional posters on patisiran and hATTR amyloidosis, will be presented at the 1 st European ATTR Amyloidosis Meeting for Patients an
AstraZeneca and Merck& Co., Inc., today announced that the US Food and Drug Administration has accepted and granted Priority Review for a supplemental New Drug Application for the use of Lynparza tablets in patients with germline BRCA-mutated, HER2-negative metastatic breast cancer who have been previously treated with chemotherapy in the neoadjuva
Atara Biotherapeutics, Inc., a leading "off-the-shelf", or allogeneic, T-cell immunotherapy company developing novel treatments for patients with cancer and autoimmune diseases, announced today that the Company initiated a multinational, multicenter Phase 1 clinical study to evaluate allogeneic ATA188 in patients with progressive or...
BioLife Solutions, Inc., the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media, today announced that its customer Kite Pharma, Inc., a wholly-owned subsidiary of Gilead Sciences, has received US FDA approval for Yescarta, the first CAR T-cell therapy for.
Bristol-Myers Squibb Company today announced that new data across serious liver diseases, including nonalcoholic steatohepatitis and hepatocellular carcinoma, will be presented at The Liver Meeting 2017 in Washington, DC, October 20 24, 2017.. The data being presented at The Liver Meeting demonstrate our commitment to advancing the scie
Calithera Biosciences, Inc., a clinical-stage pharmaceutical company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, today announced that the first patient has been treated in the Phase 1 cohort of INCB01158 in combination with Keytruda, an.
By a News Reporter-Staff News Editor at Genomics& Genetics Weekly Cerus Corporation announced that Rhode Island Blood Center received approval by the U.S. Food and Drug Administration on their Biologics License Application requesting allowance for interstate distribution of platelets that have been pathogen-reduced with the INTERCEPT Blood System
-ContraVir Pharmaceuticals, Inc., a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today it has dosed its first patient in the IND opening, Phase 1 study of tenofovir exalidex in renally-impaired patients. The study to be conducted in the U.S. will assess the safety and...
Corbus Pharmaceuticals Holdings Inc (NASDAQ:CRBP) has announced that it has observed positive results from its Phase 2 clinical study of its drug anabasum that is aimed at treating dermatomyositis. The biopharma was pleased to announce the positive results of the anabasum clinical trial results. Corbus has been developing the drug for treating derm
CStone Pharmaceuticals Co., Ltd. announced today that the first human clinical trial of CS1001, China's first fully human and full-length anti-PD-L1 monoclonal antibody, had successfully dosed the first patient in Beijing Cancer Hospital. Frank Jiang, CEO of CStone Pharmaceuticals. " After the successful enrollment of the first patient, CStone...
Daltons success is the result of how we value our employees and encourage work-life balance, explained Peter Pekos, President and CEO. We are FDA registered and Health Canada approved and bring over 30 years of experience to every project. We are experts in Custom Synthesis, cGMP API Manufacturing, Formulation Development, API Process Development,
Brigham and Women's Hospital issued the following news release:. Following a successful clinical trial involving Dana-Farber Cancer Institute and Brigham and Women's Hospital, the first chimeric antigen receptor T-cell therapy for adult cancers was approved by the Food and Drug Administration today. "Treating patients with CAR T-cells has been one
The Dana-Farber Cancer Institute issued the following news release:. Following a successful clinical trial involving Dana-Farber Cancer Institute and Brigham and Women's Hospital, the first chimeric antigen receptor T-cell therapy for adult cancers was approved by the Food and Drug Administration today. "Treating patients with CAR T-cells has been
The European Federation of Pharmaceutical Industries and Associations issued the following news release:. With over 7000 medicines in development, new treatments will continue to change patients' lives; slowing disease progression, avoiding illness and reducing overall costs for healthcare systems. But developing a new medicines is a long, complex
BB BIOTECH AG: Product approvals and solid company results lead the biotech sector higher ^ DGAP-Ad-hoc: BB BIOTECH AG/ Key word: 9- month figures BB BIOTECH AG: Product approvals and solid company results lead the biotech sector higher 20- Oct-2017/ 07:00 CET/ CEST Disclosure of an inside information acc. to Article 17 MAR, transmitted by DGAP- a
By a News Reporter-Staff News Editor at Drug Week Dr. Reddy's Laboratories Ltd. announced that it has launched Sevelamer Carbonate Tablets, 800 mg, a therapeutic equivalent generic version of Renvela Tablets, approved by the U.S. Food and Drug Administration. "We are very pleased to bring Sevelamer Carbonate Tablets to market at this time," s
Emerald Health Pharmaceuticals Inc., which is developing medications based on cannabinoid science, today announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation for its lead molecule, EHP-101, for the treatment of systemic scleroderma. "Orphan designation represents an important regulatory milestone for our compa
Enanta Pharmaceuticals, Inc., a chemistry-driven biotechnology company dedicated to creating and developing small molecule drugs for viral infections and liver diseases, today announced new data presentations on EDP-305, Enanta s lead Farnesoid X receptor agonist being developed for non-alcoholic steatohepatitis and primary biliary cholangitis,.
Oct. 20 Kite Pharma, bought by Gilead Sciences for $12 billion in August this year, has announced that the US Food and Drug Administration has granted regular approval to its cancer treatment Yescarta. The product was approve on a fast-track process. Because of the combination of this process and the innovativeness of the product there were fears
On 18 October the Food and Drug Administration approved the second gene-altering cancer treatment for patients with diffuse large B-cell lymphoma, the most common aggressive type of non-Hodgkin lymphoma, a blood cancer. The new therapy, Yescarta, is now approved only for adults who have had two or more failed chemotherapy regimens. Today is an impo
The U.S. Food and Drug Administration has approved Yescarta, a cell-based gene therapy, to treat adult patients with certain types of large B-cell lymphoma who have not responded to or who have relapsed after at least two other kinds of treatment. Yescarta, a chimeric antigen receptor T cell therapy, is the second gene therapy approved by the FDA a
-Sanford Health is launching its second adipose-derived stem cell clinical trial this one to focus on non-healing leg wounds. We have a mission here at Sanford to use research and clinical trials to make a real difference in peoples lives, said David Pearce, Ph.D., executive vice president of innovation and research at Sanford Health. Sanford Healt