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Bristol-Myers Squibb and Pfizer Enroll First Patient in Phase 4 AUGUSTUS Trial to Evaluate Safety of Eliquis (apixaban) in Nonvalvular Atrial Fibrillation Patients with a Recent Acute Coronary Syndrome or Undergoing Percutaneous Coronary Intervention

Bristol-Myers Squibb Company(link is external) and Pfizer Inc. today announced that the first patient has been enrolled into the Phase 4 clinical trial, AUGUSTUS. This two-by-two factorial, randomized controlled trial will evaluate the safety of Eliquis versus warfarin or other vitamin K antagonists (VKA) in patients with nonvalvular atrial fibrillation (NVAF) and a recent acute coronary syndrome (ACS) or undergoing percutaneous coronary intervention (PCI), also known as a stent. In addition, patients will also be randomized to aspirin or placebo. All patients will receive a P2Y12 inhibitor (such as clopidogrel) in combination with either Eliquis or a VKA. Eliquis is approved to reduce the risk of stroke and systemic embolism in patients with NVAF. read more

Launch of Netupitant-Palonosetron Fixed Combination (Akynzeo®) in the UK by Chugai Pharma UK Ltd.

TOKYO & LUGANO, Switzerland–(BUSINESS WIRE)–Chugai Pharmaceutical Co., Ltd. [Head Office: Chuo-ku, Tokyo; Chairman and CEO: Osamu Nagayama] (Chugai) (TOKYO:4519) and a wholly owned subsidiary of Chugai, Chugai Pharma Marketing Ltd. [Head Office: London, the UK; Managing Director: John Halls] (CPM) and Helsinn Group [Head Office: Lugano, Switzerland; CEO: Riccardo Braglia], the Swiss Group focused on building quality cancer care, today announced that Akynzeo®, an oral fixed-dose combination of netupitant (highly-selective NK1 receptor antagonist) and palonosetron (clinically and pharmacologically distinct 5-HT3 receptor antagonist) indicated for the prevention of chemotherapy-induced nausea and vomiting (CINV), has been launched by a wholly owned subsidiary of CPM, Chugai Pharma UK Ltd. [Head Office: London, the UK; Managing Director: Ruth Currie] (CPU), in the UK as from September 1, 2015. CPM has been granted the exclusive right of Akynzeo for sales and marketing from Helsinn Healthcare S.A. read more

Egalet Announces Scientific Data at PAINWeek 2015 Meeting Supports Analgesic Efficacy of SPRIX® Nasal Spray Versus Commonly Prescribed Oral Combination Opioids in Treatment of Moderate to Severe Short-Term Pain

WAYNE, Pa., Sept. 10, 2015 /PRNewswire/ — Egalet Corporation (Nasdaq: EGLT) (“Egalet”), a fully integrated specialty pharmaceutical company focused on discovering, developing and commercializing innovative pain treatments, today announces the presentation of scientific data at PAINWeek 2015 from a meta-analysis that shows that the treatment effect sizes of SPRIX® (ketorolac tromethamine) Nasal Spray were similar or higher than combination opioid products supporting the use of SPRIX Nasal Spray as an effective treatment option for patients who require analgesia at the opioid level. In addition, data from Category 3 human abuse liability studies being presented demonstrate the robust abuse-deterrent profile of Egalet-001, an abuse-deterrent, extended-release morphine product candidate in late-stage development for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatments are inadequate. Finally, a Category 1 abuse-deterrent study being presented demonstrates the strong physical abuse-deterrent characteristics of Egalet’s abuse-deterrent, extended-release oxycodone product candidate, Egalet-002, compared to OxyContin® (oxycodone hydrochloride). read more

INVOKANA®* Now Publicly Reimbursed in Nova Scotia for People with Type 2 Diabetes  

TORONTO, Sept. 10, 2015 /CNW/ – Effective September 1, 2015, INVOKANA® (canagliflozin), an oral, once-daily prescription treatment to lower blood sugar levels in adults with type 2 diabetes,1 will be included on the Nova Scotia public formulary. Nova Scotia joins Ontario and Quebec in providing public reimbursement for INVOKANA®. read more

Allergan Announces Agreement with Amneal Related to NAMENDA XR® Patent Litigation

DUBLIN, Sept. 10, 2015 /PRNewswire/ — Allergan plc (NYSE: AGN), today announced that its subsidiaries Forest Laboratories, LLC and Forest Laboratories Holdings, Ltd., along with Adamas Pharmaceuticals, Inc., have entered into a settlement agreement with Amneal Pharmaceuticals LLC and related companies and subsidiaries.  The settlement relates to a patent infringement litigation brought by Forest and Adamas in response to Amneal’s abbreviated new drug application (ANDA) seeking approval to market generic versions of Allergan’s NAMENDA XR® (memantine hydrochloride) extended release capsules.  It is Allergan’s understanding that Amneal is the first applicant to file an ANDA containing a paragraph IV certification regarding NAMENDA XR. read more

DelMar Pharmaceuticals Presents Updated Phase I/II Clinical Data on VAL-083 in Refractory Glioblastoma Multiforme at GBM2015  

VANCOUVER, British Columbia and MENLO PARK, Calif., Sept. 10, 2015 /PRNewswire/ — DelMar Pharmaceuticals, Inc. (OTCQX: DMPI) (“DelMar” and the “Company”), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, today presented updated clinical data from its Phase I/II study of lead product candidate VAL-083 (dianhydrogalactitol), in patients with refractory glioblastoma multiforme (GBM), at GBM2015: 2nd International Symposium on Clinical and Basic Investigation in Glioblastoma in Toledo, Spain. read more

 

 

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