AAM is the nation's leading trade association for manufacturers and distributors of FDA- approved. "Generic medicines represent greater than 89 percent of all prescriptions dispensed in the U.S., but only 26 percent of expenditures on prescription drugs, saving patients and payers nearly $5 billion every week.1Our industry is proud to be able to d
By a News Reporter-Staff News Editor at Obesity, Fitness& Wellness Week A patent application by the inventors Hoves, Sabine; Koerner, Matthias; Wang, Lisha; Yun, Hongying; Zhu, Wei; Zhang, Weixing, filed on June 14, 2017, was made available online on October 5, 2017, according to news reporting originating from Washington, D.C., by NewsRx corresp
The U.S. Department of Health and Human Services' National Institutes of Health announced that it expects to award a cooperative agreement for supporting clinical studies to repurpose existing drugs or therapeutics. The award ceiling for this funding opportunity is $3 million. It was posted on Oct. 20 with an application closing date of Nov. 5, 202
This makes China the third country, after the United States and Russia, with vaccines available for use to combat the deadly infectious disease, the China Food and Drug Administration said. The vaccine improves China's ability to prevent and control major public health threats and provides a new means for China to handle global disease epidemics ef
Drugmaker GlaxoSmithKline said the Food and Drug Administration approved it late Friday. Studies paid for by Glaxo found it prevents shingles in about 90 per cent of people. Merck' s is about 50 per cent effective. The U.S. Centers for Disease Control and Prevention, though, recommends vaccination for those 60 or older, partly because it loses effe
PASADENA, CA- 21 Oct, 2017- Former IBM Watson Health sales executive, Bill Hutchins, is joining Deep 6 AI to support the rapid expansion of its clinical trial patient recruitment platform across hospitals, pharmaceutical companies and contract research organizations. Hutchins previously served as IBM Watson for Oncology Sales Director- Western US w
Oct. 21 GlaxoSmithKline's new shingles vaccine, Shingrix, was approved Friday by the Food and Drug Administration, a potential $1 billion- a-year drug to prevent the shingles virus in adults 50 and older. The final step will be for the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices to sign off for the us
Former Attorney General of Louisiana, Charles C. Foti, Jr., Esq., a partner at the law firm of Kahn Swick& Foti, LLC, announces that KSF has commenced an investigation into PTC Therapeutics, Inc.. On February 23, 2016, PTC revealed that it had received a Refuse to File letter from the U.S. FDA on its New Drug Application for its primary drug Transl
GlaxoSmithKline issued the following news release:. GlaxoSmithKline plc today announced that the US Food and Drug Administration has approved Shingrix for the prevention of shingles in adults aged 50 years and older. Thomas Breuer, Senior Vice President and Chief Medical Officer of GSK Vaccines said: "Shingrix represents a significant scientific...
-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
The CRL indicates that the FDA cannot approve the NDA in its present form.. Based on findings in studies QST-13-003 and QST-15-005, the FDA is concerned that XYOSTED? could cause a clinically meaningful increase in blood pressure. The next step will be to request a meeting with the FDA to further evaluate the deficiencies raised and to agree upon
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...
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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