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 The leading web portal for pharmacy resources, news, education and careers November 14, 2018
Pharmacy Choice - News - Pharmaceutical Development - November 14, 2018

Pharmacy News

 Pharmaceutical Development
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11/14/18 - ADC Therapeutics Announces Presentations at 60th American Society of Hematology (ASH) Annual Meeting
Aggressive Lymphoma Results from Prospective Clinical Trials: New Agents Date and Time: Sunday, December 2, 2018; 12:15 p.m. PT Location: Marriott Marquis San Diego Marina, Pacific Ballroom 20 Presenter: John Radford, MD, FRCP, Manchester Academic Health Centre, The University of Manchester and The Christie NHS Foundation Trust, Manchester, UK.
11/14/18 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Disclosures of Descriptive Presentations in Professional Oncology Prescription Drug Promotion
Agency: " Food and Drug Administration, HHS." SUMMARY: The Food and Drug Administration is announcing that a proposed collection of information has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995.. FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, Food an
11/14/18 - Aldeyra Therapeutics Announces Third Quarter 2018 Financial Results
Aldeyra Therapeutics, Inc., a biotechnology company devoted to development of next-generation medicines to improve the lives of patients with immune-mediated diseases, today announced financial results for the third quarter ended September 30, 2018. Aldeyra plans to initiate a Phase 3 clinical trial in 2019, following discussions with regulatory.
11/14/18 - Amplyx Doses First Patient in Phase 2 Trial of APX001 in Patients with Candida Infection
SAN DIEGO- Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening infections, today announced that the first patient has been dosed in the Company's Phase 2 clinical program to evaluate the efficacy and safety of APX001 in the treatment of infections caused by Candida. 'Initiating our Phase 2 program for APX001...
11/14/18 - Amplyx Doses First Patient in Phase 2 Trial of APX001 in Patients with Candida Infection [Sudan Tribune]
Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening infections, today announced that the first patient has been dosed in the Company`s Phase 2 clinical program to evaluate the efficacy and safety of APX001 in the treatment of infections caused by Candida. "Initiating our Phase 2 program for APX001 represents a
11/14/18 - Aravive Presents Detailed Results of Phase 1 Clinical Trial of AVB-S6-500 at the 2018 EORTC-NCI-AACR Symposium [Syrian Arab News Agency]
Aravive, Inc., a clinical-stage biopharmaceutical company, today announced detailed results of its first-in-human Phase 1 clinical trial of AVB-S6-500 in healthy volunteers. As previously announced, the trial met the safety and tolerability endpoints for the trial and demonstrated clinical proof-of-mechanism for AVB-S6-500 in neutralizing GAS6, a k
11/14/18 - ASIT biotech Reaches a Key Milestone in the Development of a New Drug for Peanut Allergy by Finalizing the Industrialization Process for the Manufacture of Clinical Batches of its pnt-ASIT+ Product Candidate [Tehran Times (Iran)]
ASIT biotech, a Belgian biopharmaceutical company specialized in the research and development of innovative allergy immunotherapy products, today announced that it has finalized the industrialization process for the manufacture of clinical batches of its pnt-ASIT+ product candidate. Mohamed Shamji and his team on the blood cells of allergic patient
11/14/18 - Attenua Announces First Patient Treated in Phase 2 Clinical Trial in Chronic Cough with Bradanicline
Attenua, Inc., a clinical-stage biopharmaceutical company focused on developing novel medicines to treat cough, today announced that the first patient has been treated in a Phase 2 clinical trial in chronic cough with bradanicline, its lead compound. "Within just six months of our initial Series A funding, Attenua has successfully filed an Inves
11/14/18 - Axsome Therapeutics Announces Completion of Patient Enrollment in the ASCEND Phase 2 Trial of AXS-05 in Major Depressive Disorder
Axsome Therapeutics, a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system disorders, today announced the completion of patient enrollment in the ASCEND study, a Phase 2 randomized, controlled trial of AXS-05 in major depressive disorder. ASCEND is evaluating the effect of AXS-05 as compa
11/14/18 - Biohaven Pharmaceuticals Reports Third Quarter 2018 Financial And Recent Business Results
Biohaven Pharmaceutical Holding Company Ltd., a clinical-stage biopharmaceutical company with a portfolio of innovative, late-stage product candidates targeting neurological diseases, including rare disorders, today reported financial results for the quarter ended September 30, 2018, and provided a review of recent accomplishments and...
11/14/18 - BioXcel Therapeutics Reports Positive Results from Study in Agitated Schizophrenia PatientsSupporting BXCL501 Clinical Development
BioXcel Therapeutics, Inc., a clinical stage biopharmaceutical development company utilizing novel artificial intelligence to identify the next wave of medicines across neuroscience and immuno-oncology, today announced positive results from a Phase 1 b study evaluating intravenously administered dexmedetomidine for acute treatment of agitation...
11/14/18 - Canon Medical Receives FDA Clearance for Premium MR System: Vantage Orian 1.5T
Canon Medical Systems USA, Inc. has received 510 clearance on its new premium MRI system, Vantage Orian? 1.5 T. The Vantage Orian represents a new standard in the premium wide bore 1.5 T market with new technology designed to boost productivity, enhance patient comfort and deliver diagnostic clinical confidence. We are committed to offering ou
11/14/18 - CASI Pharmaceuticals Announces Third Quarter and First Nine Months 2018 Financial and Business Results
CASI Pharmaceuticals, Inc., a biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world, today reported financial results for the third quarter and nine months ended September 30, 2018 and provided
11/14/18 - CASI PHARMACEUTICALS, INC. - 10-Q - MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS.
We are a U.S. based biopharmaceutical company dedicated to the development and delivery of high quality, cost-effective pharmaceutical products and innovative therapeutics to patients in the U.S., China and throughout the world. We intend to execute our plan to become a leading pharmaceutical company with a substantial market share in China.
11/14/18 - Clinical Laboratory Services Market to reach $333.45 billion by 2023 including key players Spectra Laboratories, Sonic Healthcare Ltd., Siemens
According to Research, the Global Clinical Laboratory Services market is estimated at $205.56 billion in 2016 and is expected to reach $333.45 billion by 2023 growing at a CAGR of 7.1% from 2016 to 2023.. The study covers geographic analysis that includes regions like North America, Europe, Asia Pacific, Middle East& Africa, Rest of Middle East& Af
11/14/18 - Clinical trial of Inofer: half of the patients already recruited
The tenth patient of twenty has now been recruited for the clinical study of the iron tablets Inofer, which Drugsson AB has the rights to in Sweden, Norway, Denmark and Finland. The clinical trial of Inofer was approved as previously reported, by the Swedish Medical Products Agency and the Ethical vetting board on 20 June, commencing on October 4 w
11/14/18 - Cybrexa Therapeutics Presents Preclinical Data Demonstrating its alphalex Tumor Targeting Platform Delivers a High Dose of PARP Inhibitor in Combination with Chemotherapy [Sport360]
-Cybrexa Therapeutics, a biotechnology company developing a new class of cancer therapeutics through its alphalex tumor targeting platform, today announced that the company presented preclinical data regarding the alphalex platforms application to a poly polymerase inhibitor. These data were presented today during the 30th EORTC-NCI-AACR Molecular.
11/14/18 - DelMar Pharmaceuticals Announces First Quarter Fiscal Year 2019 Financial Results
VANCOUVER, British Columbia and MENLO PARK, Calif., Nov. 14, 2018/ PRNewswire/ DelMar Pharmaceuticals, Inc., a biopharmaceutical company focused on the development of new cancer therapies, announced its financial results for the first quarter ended September 30, 2018. "During the quarter, we continued to focus on advancing our Phase 2 clinical t
11/14/18 - FDA approve drug that reduces cow poo smell [Tehran Times (Iran)]
The new drug, named Experior, has been designed to make cow pastures that bit more environmentally friendly and less smelly! These ammonia gasses can come from many sources and can affect the health of people, animals and the environment, said Steven Solomon, who is the director of the FDAs Center for Veterinary Medicine. The product was tested ext
11/14/18 - FDA Approves Empliciti Combination for Relapsed or Refractory Multiple Myeloma [Syrian Arab News Agency]
The U.S. Food and Drug Administration has approved Bristol-Myers Squibbs Empliciti, in combination with Pomalyst and low-dose dexamethasone, as a treatment for patients with relapsed or treatment-resistant multiple myeloma. Empliciti plus pomalidomide and dexamethasone has been proven to extend the time that certain patients live without disease...
11/14/18 - FDA Grants Orphan Drug Designation To RGX-181 Gene Therapy For The Treatment Of CLN2 Form Of Batten Disease
REGENXBIO Inc., a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV Technology Platform, today announced the U.S. Food and Drug Administration granted Orphan Drug Designation to RGX-181, a one-time treatment candidate for late-infantile neuronal cer
11/14/18 - FDA Grants Priority Review to Roche's Tecentriq in Combination With Abraxane for the Initial Treatment of People With PD-L1-Positive, Metastatic Triple-Negative Breast Cancer
Roche, a biotech company, issued the following news release:. Roche today announced the US Food and Drug Administration has accepted the company's supplemental Biologics License Application and granted Priority Review for Tecentriq (R) plus chemotherapy for the initial treatment of unresectable locally advanced or metastatic triple-negative breast.
11/14/18 - FDA Updates Expanded Access Program to Boost Patient Experiences [Tehran Times (Iran)]
EA provides a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases and immediately life-threatening conditions outside of clinical trials when no comparable or satisfactory approved alternative therapy options are available, FDA Commissioner Scott Gottlieb, MD, said in a statement.
11/14/18 - FDA Warns StemGenex Biologic Laboratories LLC of Illegally Marketing an Unapproved Cellular Product Manufactured in a Facility With Significant Manufacturing Violations, Putting Patients at Risk
The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requireme
11/14/18 - Fervent Pharmaceuticals Completes Clinical Trial For Promising New Post-Menopausal Therapy Treating Vasomotor Symptoms
Fervent Pharmaceuticals of Greenville, N.C. has successfully completed its Phase 2 A clinical trial for FP-101, a new therapy developed to treat the vasomotor symptoms associated with menopause, like hot flashes and night sweats. "Completing this clinical trial brings us one step closer to achieving our mission, which is to better women's lives
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