AXIM Biotechnologies, Inc a world leader in cannabinoid research and development, today announced that it has entered into a Clinical Study Agreement (CSA) with the University of British Columbia in Canada to begin a clinical trial with its CanChew Plus® cannabidiol (CBD) chewing gum product to treat drug-induced psychosis in adult patients.
AstraZeneca and Merck & Co., Inc. known as MSD outside of the United States and Canada, announced that they have entered a global strategic oncology collaboration to co-develop and co-commercialize AstraZeneca’s LYNPARZA (olaparib) for multiple cancer types. LYNPARZA is an innovative, first-in-class oral poly ADP ribose polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment.
Titan Pharmaceuticals, Inc. a specialty pharmaceutical company developing proprietary therapeutics for the treatment of select chronic diseases utilizing its ProNeura™ long-term, continuous drug delivery technology, announced today that it has entered into a venture loan and security agreement with Horizon Technology Finance Corporation, which provides Titan with up to $10 million of available borrowing capacity.
Amgen announced that the U.S. Food and Drug Administration (FDA) has granted priority review for Amgen's supplemental Biologics License Application (sBLA) for Repatha® (evolocumab), a PCSK9 inhibitor. If approved by the FDA, the U.S. Prescribing Information for Repatha will be updated to include risk reduction of major cardiovascular events based on data from the large cardiovascular outcomes study (FOURIER). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Dec. 2, 2017.
Verona Pharma plc a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for respiratory diseases, announces today that the first patients have been dosed in a Phase 2b clinical trial evaluating RPL554 as a maintenance treatment for chronic obstructive pulmonary disease (“COPD”). Verona Pharma expects to report top-line data from this trial in the second half of 2018.
Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Desonide Cream, 0.05%, the generic version of Desonide Cream, 0.05% of Perrigo New York Inc.
Axsome Therapeutics, Inc a clinical-stage biopharmaceutical company developing novel therapies for the management of central nervous system (CNS) disorders, announced positive topline clinical trial results from a Phase 1 pharmacokinetic study of AXS-06, a novel, oral, non-opioid, fixed-dose combination of meloxicam and esomeprazole being developed for the treatment of osteoarthritis and rheumatoid arthritis. Axsome has received, from the U.S. Food and Drug Administration (FDA), Pre-Investigational New Drug Application (Pre-IND) written guidance on a proposed clinical developmental plan for AXS-06. Based on this guidance, Axsome believes that AXS-06 is Phase 3-ready. AXS-06 is now Axsome’s third product candidate in clinical development and its second differentiated oral, non-opioid product candidate for the management of chronic pain.
A nine-year-old South African child who was diagnosed with HIV infection at one month of age and received anti-HIV treatment during infancy has suppressed the virus without anti-HIV drugs for eight and a half years, scientists reported today at the 9th IAS Conference on HIV Science in Paris. This case appears to be the third reported instance of sustained HIV remission in a child after early, limited anti-HIV treatment.
Gilead Sciences, Inc. announced detailed 48-week results from two Phase 3 studies (Studies 1489 and 1490) evaluating the efficacy and safety of a fixed-dose combination of bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor (INSTI), and emtricitabine/tenofovir alafenamide (200/25mg) (FTC/TAF), a dual-NRTI backbone, for the treatment of HIV-1 infection in treatment-naïve adults. In the ongoing studies, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing dolutegravir (50mg) (DTG) in combination with a dual-NRTI backbone. The data were presented in two late-breaker sessions [MOAB01 and TUPDB02] at the 9th IAS Conference on HIV Science (IAS 2017) in Paris.
Astrazeneca to launch Osimertinib Tablet 40 mg and 80 mg (Tagrisso™) in India after it received nod from Drug Controller General of India. Also stoke pricing of the company is increased by 3 % followed by this announcement.