Industry News

WHO and EU commit to work together to accelerate progress on health

  • Posted on: 23 November 2018
  • By: Shalini.Sharma

Dr Tedros commended the fruitful cooperation between the Commission and WHO, particularly in the fields of antimicrobial resistance, strengthening health systems and preparedness for outbreaks of communicable diseases in developing countries. President Juncker confirmed the support of the European Commission to the Global Action Plan on Health and Well Being to accelerate progress  to achieve Sustainable Development Goals, including goal number 3, related to healthy lives and well-being at all ages.

FDA approves new treatment for patients with acute myeloid leukemia

  • Posted on: 22 November 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are 75 years of age or older or who have other chronic health conditions or diseases (comorbidities) that may preclude the use of intensive chemotherapy.

EMA committee grant marketing authorisation for the gene therapy Luxturna

  • Posted on: 22 November 2018
  • By: Shalini.Sharma

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for the gene therapy Luxturna (voretigene neparvovec), for the treatment of adults and children suffering from inherited retinal dystrophy caused by RPE65 gene mutations, a rare genetic disorder which causes vision loss and usually leads to blindness.

EMA committee recommend marketing authorization for vamomere

  • Posted on: 22 November 2018
  • By: Shalini.Sharma

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Vabomere (meropenem trihydrate/vaborbactam), a new treatment option against the following infections in adults: Complicated urinary tract infection, including pyelonephritis, a sudden and severe infection causing the kidneys to swell and which may permanently damage them; Complicated intra-abdominal infection; Hospital-acquired pneumonia, including ventilator associated pneumonia; Bacteria in the blood associated with any of the infections listed above; Infections due to aerobic Gram-negative organisms in adults with limited treatment options.

EMA recommend marketing aurthorization for medicine for the prevention of migraine

  • Posted on: 22 November 2018
  • By: Shalini.Sharma

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Emgality (galcanezumab), a monoclonal antibody for the prevention of migraine. Emgality belongs to a new class of medicines that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks.

FDA new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk

  • Posted on: 21 November 2018
  • By: Shalini.Sharma

As Commissioner of the U.S. Food and Drug Administration, I remain committed to finding new ways to reduce the burden of chronic disease through improved nutrition. Using the FDA’s labeling tools to foster innovation toward healthier foods that consumers want is one of the primary goals of the FDA’s Nutrition Innovation Strategy that I first announced in March.

WHO and partners launch new country-led response to put stalled malaria control efforts back on track

  • Posted on: 21 November 2018
  • By: Shalini.Sharma

Reductions in malaria cases have stalled after several years of decline globally, according to the new World malaria report 2018. To get the reduction in malaria deaths and disease back on track, WHO and partners are joining a new country-led response, launched today, to scale up prevention and treatment, and increased investment, to protect vulnerable people from the deadly disease.

FDA approves first-line treatment for peripheral T-cell lymphoma under new review pilot

  • Posted on: 20 November 2018
  • By: Shalini.Sharma

The U.S. Food and Drug Administration expanded the approved use of Adcetris (brentuximab vedotin) injection in combination with chemotherapy for adult patients with certain types of peripheral T-cell lymphoma (PTCL). This is the first FDA approval for treatment of newly diagnosed PTCL, and the agency used a new review program to complete the approval more quickly.

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