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.
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
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.
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...
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
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
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
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
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
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...
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...
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
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
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.
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
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
-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.
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
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
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...
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
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.
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.
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
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