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  • 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).

  • AstraZeneca  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 lesinurad 200mg tablets. Lesinurad, in combination with a xanthine oxidase inhibitor (XOI), is recommended for the adjunctive treatment of hyperuricaemia in adult gout patients (with or without tophi) who have not achieved target serum uric acid levels (sUA) with an adequate dose of a XOI alone.

  • Cipla Ltd, a Rs. 10,880 crore plus fifth largest pharma company in India, has launched generic drug ledipasvir-sofosbuvir in India under the brand name Hepcvir-L. Hepcvir- L, the first once-a-day, fixed-dose oral combination therapy that has been approved for chronic hepatitis C genotype 1 patients.

  • The U.S. Food and Drug Administration approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent. The LifeVest defibrillator is manufactured by the ZOLL Manufacturing Corporation based in Pittsburgh, Pennsylvania.

  • Highlights:

    • There will be a separate ministry of Pharmaceuticals & Medical Devices which will be created within one year which will ease the working for the Industry with a single point contact.
    • Katoch Committee Report on the API and Bulk Drugs Policy will be accepted within 100 days
    • Inverted duty issues will be taken up by him personally with the Hon’ble Finance Minister based on the recommendations of PHD Chamber.

    This conference was held in association with Department of Pharmaceuticals, Ministry of Chemical & Fertilizers Government of India. The main objective of the Conference was to promote innovation and boost Pharmaceutical and Medical Devices manufacturing Industry through technology transfer and focus on high value production to provide world class Affordable, Acceptable and Accessible health care products. The Conference created a neutral platform wherein strategies & policy issues were discussed for the growth of the Healthcare industry.

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