Pharma News

AXIM Biotech enters Clinical Study agreement with university of British Columbia Clinical Trial on CBD Chewing Gum for Treatment of Drug-Related Psychosis

  • Posted on: 3 August 2017
  • By: PharmaTutor News

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 Establish Strategic Oncology Collaboration

  • Posted on: 28 July 2017
  • By: PharmaTutor News

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 Secures $10 Million Debt Facility From Horizon Technology Finance

  • Posted on: 28 July 2017
  • By: PharmaTutor News

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.


FDA Grants Priority review for Amgen's Supplemental Biologics License

  • Posted on: 28 July 2017
  • By: PharmaTutor News

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 Doses First Patients in Phase 2b Clinical Trial of RPL554 for COPD Maintenance Treatment

  • Posted on: 27 July 2017
  • By: PharmaTutor News

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.


Axsome Therapeutics announces AXS-06 (MoSEIC™ Meloxicam and Esomeprazole) Meets Primary Endpoint in Phase 1 Clinical Trial

  • Posted on: 26 July 2017
  • By: PharmaTutor News

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.


Child Living with HIV Maintains Remission Without Drugs Since 2008

  • Posted on: 24 July 2017
  • By: PharmaTutor News

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 announces Phase 3 Results for Investigational Fixed-Dose Combination of Bictegravir, Emtricitabine and Tenofovir Alafenamide for Treatment of HIV

  • Posted on: 24 July 2017
  • By: PharmaTutor News

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.


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