Industry News

EMA and USFDA Workshop on how to better support medicine developers in the generation and preparation of quality data packages for PRIME and Breakthrough Therapy applications

  • Posted on: 25 November 2018
  • By: Shalini.Sharma

EMA and the US Food and Drug Administration (FDA) are organising a workshop on 26 November 2018 to discuss how regulators can better guide and support medicine developers in generating quality and manufacturing data packages in the context of development support programmes, such as the PRIority MEdicines scheme (PRIME) in the EU and Breakthrough Therapy designation programme in the US. The goal is to help patients to benefit as early as possible from these therapies that target serious or life-threatening diseases or unmet medical needs.

India's first chatbot for patients launched by Lupin

  • Posted on: 25 November 2018
  • By: Shalini.Sharma

Lupin announced the launch of a chatbot named ‘ANYA’ specially designed to provide medically verified information for health-related queries. ANYA is the first bot of its kind to be launched in India for disease awareness. It’s a made in India for India initiative aimed at answering patient queries related to ailments.

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.

Pages