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- Read more about FDA approves an oncology drug that targets a key genetic driver of cancer, rather than a specific type of tumor
The U.S. Food and Drug Administration granted accelerated approval to Vitrakvi (larotrectinib), a treatment for adult and pediatric patients whose cancers have a specific genetic feature (biomarker).
- Read more about Democratic Republic of the Congo begins first-ever multi-drug Ebola trial: WHO
The Ministry of Health of the Democratic Republic of the Congo (DRC) announced that a randomized control trial has begun to evaluate the effectiveness and safety of drugs used in the treatment of Ebola patients. The trial is the first-ever multi drug trial for an Ebola treatment. It will form part of a multi-outbreak, multi-country study that was agreed to by partners under a World Health Organization (WHO) initiative.
- Read more about 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
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.
- Read more about India's first chatbot for patients launched by Lupin
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.
- Read more about Cabinet approves Allied and Healthcare Council of India and corresponding State Allied and Healthcare Councils
The Union Cabinet chaired by Prime Minister Shri Narendra Modi has approved the establishment of an Allied and Healthcare Council of India and corresponding State Allied and Healthcare Councils which will play the role of standard-setters and facilitators for professions of Allied and Healthcare. Thanking the Prime Minister Shri Narendra Modi for his visionary leadership and constant guidance, Shri Nadda said that he is grateful to the Prime Minister for approving a landmark legislation which will provide employment opportunities to millions of youth in the country and will help standardize allied healthcare.
- Read more about WHO and EU commit to work together to accelerate progress on health
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.
- Read more about FDA approves new treatment for patients with acute myeloid leukemia
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.
- Read more about EMA committee grant marketing authorisation for the gene therapy Luxturna
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.
- Read more about EMA committee recommend marketing authorization for vamomere
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.

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- Read more about EMA recommend marketing aurthorization for medicine for the prevention of migraine
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.