The US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Boehringer Ingelheim's novel, 3rd-generation, epidermal growth factor receptor (EGFR) mutation-specific tyrosine kinase inhibitor (TKI), BI 1482694 (HM61713). The BTD is based on results from the phase I/II HM-EMSI-101 clinical trial which were presented at the ESMO Asia 2015 Congress in Singapore.
AstraZeneca, a global, science-led biopharmaceutical business, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of Tagrisso (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC).
The US Food and Drug Administration approved Torax Medical In's Fenix continence restoration system to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options.
Besides opening up new vistas for humans, ranging from travel to exotic places to enjoying the products and services of those distant lands, international trade and travel also increases risk of spreading infectious diseases, a study says.
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India became the world's third country with the prowess to manufacture raw materials for nanomedicines, addressed a growing public health concern by approving a new drug for hepatitis C and made strides in 3D printing in healthcare as 2015 ended on a cliff-hanger with the launch of the world's first anti-dengue vaccine in Mexico giving hope to the South Asian country.
South Korean health authorities declared an official end to the Middle East Respiratory Syndrome (MERS) outbreak, more than seven months after the first patient was found on May 20.
The White House released a plan to combat "global rise" of multidrug-resistant tuberculosis (MDR-TB).
People facing mental health issues should not be subjected to neglect and marginalization, said President Pranab Mukherjee on Tuesday.
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