Medical Tidbits, Vertex Awards $1 Million in Grants to 18 Non-profit Organizations to Advance Initiatives for People Living with Cystic Fibrosis

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–(BUSINESS WIRE)– Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced it has awarded the company’s 2016 Cystic Fibrosis (CF) Circle of Care grants, totaling approximately $1 million, to 18 non-profit medical, academic, patient and community organizations. In its second year, the grants fund innovative programs to help the cystic fibrosis community. CF is a rare, life-threatening genetic disease affecting approximately 75,000 people in North America, Europe and Australia.

Despite improvements in the treatment of CF, physical and emotional support for patients and caregivers is a continuing need. Vertex’s Cystic Fibrosis Circle of Care initiative promotes collaboration and provides funding to non-profits that can enhance care and resources for people with CF.

During this year’s process, 58 proposals were received from organizations in 15 countries – a 15 percent increase in total applicants since last year. Ultimately 18 projects from Australia , Austria , Belgium , Canada , Czech Republic , France , Germany , the Netherlands and the United States were selected by a multidisciplinary group of internal and independent experts, including a CF nurse, pulmonologist and parent of a CF patient. View the full list of recipients here.

The organizations and projects selected met at least one of the following goals:

  • Help people with CF live a fuller, more engaged lifestyle;
  • Address the psychological and social challenges CF patients face;
  • Improve overall support to family and caregivers;
  • Provide tools that help CF patients take more ownership of their healthcare needs; and
  • Educate CF patients on topics including lifestyle transitions, adherence and navigating new environments. read more

Gilead Announces Data From New Preclinical Study Evaluating an Investigational TLR7 Agonist in SIV-Infected Monkeys

Gilead Sciences, Inc. (NASDAQ:GILD) today announced results from a preclinical study conducted in collaboration with researchers at Beth Israel Deaconess Medical Center evaluating a proprietary investigational oral toll-like receptor 7 (TLR7) agonist, GS-9620, and a related molecular analogue, GS-986, as part of an HIV eradication strategy. Data from the study conducted in simian immunodeficiency virus (SIV)-infected virally suppressed rhesus macaques on antiretroviral therapy (ART) demonstrate that TLR7 agonist treatment induced transient plasma SIV RNA blips and reduced SIV DNA. In addition, TLR7 agonist treatment resulted in subsequent prolonged virus suppression in some of the macaques after stopping ART. These data were presented in an oral session (Session O-7) at the 2016 Conference on Retroviruses and Opportunistic Infections (CROI) in Boston. – read more

FDA Accepts and Grants Priority Review for AVYCAZ® (ceftazidime and avibactam) Supplemental New Drug Application (sNDA)

PRNewswire/ — Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has accepted for filing the company’s supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam). This filing will add important new clinical data to the current label from two Phase 3 trials evaluating the safety and efficacy of AVYCAZ, in combination with metronidazole, for the treatment of complicated intra-abdominal infections (cIAI), including patients with infections due to ceftazidime-nonsusceptible (CAZ-NS) pathogens. The FDA granted priority review status to this application based on the previous Qualified Infectious Disease Product (QIDP) designation for AVYCAZ. Allergan expects the Agency to take action on the filing in the second quarter of 2016. read more

Boston Scientific Announces Changes to Board of Directors

Chairman Pete Nicholas to retire; President and CEO Mike Mahoney to become chairman

MARLBOROUGH, Mass., Feb. 25, 2016 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced today a number of changes to the leadership and membership of its Board of Directors.

Pete M. Nicholas, the company’s co-founder and chairman of its board, has announced that he will retire from the board at the 2016 Annual Meeting of Stockholders in May. Pete served as Boston Scientific’s chief executive officer and co-chairman of the board since its founding in 1979. In 1995, Pete stepped down as CEO and became its chairman. During his almost 40 years of leadership, the company grew to become a global leader in the field of interventional medicine, improving the lives of patients worldwide. read more

Acalabrutinib RecommendEd for Orphan Drug Designation IN EUROPE for THREE indications

AstraZeneca and Acerta Pharma BV, a company in which AstraZeneca has a majority equity investment, today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) adopted three positive opinions recommending acalabrutinib (ACP-196) for designation as an orphan medicinal product. The three positive opinions are for the treatment of chronic lymphocytic leukaemia (CLL) / small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL) and lymphoplasmacytic lymphoma (Waldenström’s macroglobulinaemia, MG). read more

Life-threatening bowel ischemia can often be treated by balloon angioplasty

Acute mesenteric ischemia (AMI) can be successfully treated with endovascular therapy such as balloon angioplasty, according to research from the University of Eastern Finland. The study also found that AMI is a more common cause of abdominal pain among the elderly than generally thought; however, it is difficult to diagnose before bowel damage develops.

If left untreated, acute mesenteric ischemia usually leads to gangrenous bowel, which is a life-threatening condition. AMI usually results from an occlusion of the superior mesenteric artery, typically caused by arteriosclerosis or embolism, a blood clot originating from the heart. Previously, the most common course of treatment was resection of gangrenous bowel – that is if anything at all could be done, as the overall mortality rate was over 80%.read more

Teleflex Launches New Arrow® VPS® Stylet

WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, announced it has received FDA 510(k) clearance to market a newly designed Arrow® VPS® Stylet. The new design allows Teleflex to provide hospitals with a complete offering of single, double and triple lumen pre-loaded, pressure injectable Arrow® PICC with Chlorag+ard® Technology for use with its current Arrow® VPS® Device platform. Together these technologies provide an easy solution for clinicians who are dedicated to reducing central venous catheter malposition while helping prevent microbial colonization and thrombus accumulation on catheter surfaces read more

True North Therapeutics Receives Orphan Drug Designation in the European Union for TNT009 for the Treatment of Autoimmune Hemolytic Anemia, including Cold Agglutinin Disease (CAD)

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–True North Therapeutics, a clinical stage biotechnology company developing novel therapies for Complement-mediated rare diseases, today announced that the European Medicines Agency (EMA) granted Orphan Drug Designation for TNT009 for the treatment of autoimmune hemolytic anemia including Cold Agglutinin Disease (CAD), in which autoantibodies target and destroy red blood cells, causing anemia, fatigue and potentially fatal thrombosis. read more

Alkermes Announces Positive Topline Results From Clinical Study of Two-Month Dosing Option of ARISTADA® for Treatment of Schizophrenia

DUBLIN, Ireland–(BUSINESS WIRE)–Alkermes plc (NASDAQ: ALKS) today announced positive topline data from a randomized, open-label, pharmacokinetic (PK) study evaluating a two-month dosing interval of ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. Results from the study showed that the 1064 mg dose of ARISTADA achieved therapeutically relevant plasma concentrations of aripiprazole with a PK profile that supports dosing once every two months. The most common adverse events for the two-month dosing interval were injection site pain and dyskinesia. Based on these results, Alkermes plans to submit a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2016 read more

inviCRO Acquires Molecular Neuroimaging (MNI) to Establish Full Spectrum Translational Imaging Capabilities

BOSTON–(BUSINESS WIRE)–inviCRO, LLC, and Molecular NeuroImaging, LLC, both leading providers of imaging service solutions and analysis for research and drug development, announced they will merge all activities to provide the most comprehensive set of imaging services across the spectrum of drug development. inviCRO has acquired MNI and MNI will operate as a division of inviCRO. read more

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