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Allergan and Gedeon Richter Plc. to Present Data from Cariprazine trials at European College of Neuropsychopharmacology (ECNP) Annual Meeting in Amsterdam

— Presentations Include Cariprazine Data in Schizophrenia Patients with Predominant Negative Symptoms, Schizophrenia Relapse Prevention —

DUBLIN and BUDAPEST, Hungary, Aug. 25, 2015 /PRNewswire/ — Allergan plc (NYSE: AGN) and Gedeon Richter Plc today announced they will present data on the investigational drug cariprazine in patients with schizophrenia and acute mania in bipolar I disorder during the 28th European College of Neuropsychopharmacology (ECNP) annual congress in Amsterdam, to be held August 29 – September 1, 2015. read more

FDA and EMA accept regulatory applications for Boehringer Ingelheim’s Giotrif® / Gilotrif® (afatinib) for treatment of advanced squamous cell carcinoma of the lung

INGELHEIM, Germany–(EON: Enhanced Online News)–Boehringer Ingelheim today announced that both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have accepted filing applications for afatinib for the treatment of patients with advanced SCC of the lung progressing after treatment with first-line chemotherapy. Afatinib has also been granted orphan drug designation by the FDA – a status given to a product intended for the treatment of a rare disease or condition. read more

Acorda Announces Patent Trials and Appeal Board (PTAB) Denies Both IPRs of AMPYRA Patents

ARDSLEY, N.Y.–(BUSINESS WIRE)–Acorda Therapeutics, Inc. (Nasdaq:ACOR ) today announced that the United States Patent and Trademark Office (USPTO) Patent Trials and Appeal Board (PTAB) will not institute the inter partes review (IPR) of U.S. Patent Nos. 8,663,685 (“the ‘685 patent”) and 8,007,826 (“the ‘826 patent”).  read more

Covance Announces Pioneering Agreement with Leading Pharmaceutical Company for Worldwide Portfolio-Level Clinical Trial Monitoring

PRINCETON, N.J.–(BUSINESS WIRE)–Laboratory Corporation of America® Holdings (LabCorp®) (NYSE: LH) today announced that Covance Drug Development (Covance) has received a multi-year award from a leading pharmaceutical company to use Covance’s Xcellerate® platform as an exclusive central monitoring solution for their worldwide clinical trials portfolio. This landmark agreement with a top-tier pharmaceutical company for Covance’s first-in-kind Software-as-a-Service (SaaS) offering reflects the company’s unique technology capabilities, and reinforces its position as an industry innovator and leader in clinical informatics solutions. read more

Medeon Biodesign Receives FDA 510(k) Clearance for ClickClean(TM) – Laparoscope Lens Cleaning Device

LOS ALTOS, Calif. and TAIPEI, Aug. 25, 2015 /PRNewswire/ — Medeon Biodesign, Inc., a Taiwan medical device company, is pleased to announce that the company has received U.S. Food and Drug Administration 510(k) clearance for ClickClean, a lens cleaning device. ClickClean provides instant, in-situ, one-click lens cleaning during laparoscopic procedures, which virtually eliminates the need to remove the laparoscope from the body cavity during surgery and significantly reduces the total time, cost, risks and repeated frustration associated with maintaining a clear visual field. read more

BOSTON SCIENTIFIC CLOSES ACQUISITION OF THE AMERICAN MEDICAL SYSTEMS MALE UROLOGY PORTFOLIO

Boston Scientific Corporation (NYSE: BSX) has closed on the previously announced agreement with Endo International plc (NASDAQ: ENDP) (TSX: ENL) to purchase American Medical Systems’ (AMS) Men’s Health and Prostate Health businesses, for $1.6 billion in up-front cash and a potential additional $50 million milestone based on 2016 sales. The acquisition positions Boston Scientific as a leader in urology, providing physicians and healthcare systems a comprehensive portfolio of proven technologies. read more
FDA expands use of Novartis drug Promacta® to include treatment of children ages 1 and older with chronic immune thrombocytopenia
EAST HANOVER, N.J., Aug. 24, 2015 /PRNewswire/ — Novartis announced today that the US Food and Drug Administration (FDA) has approved an expanded use for Promacta® (eltrombopag) to include children 1 year of age and older with chronic immune thrombocytopenia (ITP) who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. read more
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