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  • The Central Drugs Standard Control Organisation (CDSCO) has decided to make the regulations more stringent to tackle the menace of the widespread misuse of Oxytocin, a neurotransmitter and peptide hormone, in dairy and horticulture industry crop up on a daily basis. The Regulatory body will hold a crucial meeting on February 22 at 11:00Am in Delhi with all the manufacturers of Oxytocin formulation for human and animal use in the country.

  • FDA amended its regulations on the acceptance of data from clinical investigations for medical devices. The rule updates the FDA’s standards for accepting clinical data from clinical investigations conducted both inside and outside the United States to help ensure the protection of human participants, and to help ensure the quality and integrity of data obtained from these clinical investigations.

  • The genetic cause behind a strain of typhoid’s resistance to five classes of antibiotics has been uncovered by scientists at the Wellcome Sanger Institute and their collaborators at Public Health England and Aga Khan University, Pakistan. There is currently a major outbreak of typhoid fever in Pakistan, and there was a case in the UK following air travel, which has been isolated and treated. This study shows the typhoid strain causing the outbreak acquired an additional piece of DNA to become resistant to multiple antibiotics, including a third-generation antibiotic.

  • Technion researchers have successfully treated a cancerous tumor using a “nano-factory” – a synthetic cell that produces anti-cancer proteins within the tumor tissue. The research, which was published in Advanced Healthcare Materials, combines synthetic biology, to artificially produce proteins, and targeted drug delivery, to direct the synthetic cell to abnormal tissues.

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  • Celgene Corporation announced that data from the phase III RELIEF™ clinical trial of OTEZLA® (apremilast) in patients with active Behçet’s Disease with oral ulcers were presented in a late-breaking oral presentation at the 2018 American Academy of Dermatology (AAD) Annual Meeting. The results showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily (BID) versus placebo through week 12. OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4).

  • WHO is announcing a new high-level commission, comprised of heads of state and ministers, leaders in health and development and entrepreneurs. The group will propose bold and innovative solutions to accelerate prevention and control of the leading killers on the planet – noncommunicable diseases (NCDs) like heart and lung disease, cancers, and diabetes.

  • The government is looking to bring in a new pharma policy for implementing the proposed healthcare plan across the country in the next couple of months, Union Chemicals and Fertilisers Minister Ananth Kumar said. The big healthcare initiative announced in the budget for 2018-19 seeks to cover 10 crore households requires many verticals -- infrastructure, human resources and pharma and medical device products, Kumar told.

  • FSSAI has notified the Food Safety and Standards (Import) First Amendment Regulations, 2018.

    This notification amends the requirement relating to
    a. shelf life of imported product at the time of port clearance. As per this notification, Custom Authorities shall not clear any article of food unless it has a valid shelf life of not less than sixty per cent, or three months before expiry, whichever is less, at the time of import”
    b.  Further, one more provision stating “the importer shall submit certificate of sanitary export from authorized agencies in exporting countries for the categories of food as may be specified by the Food Authority from time to time” has also been inserted. This will help in the risk prioritization and in effectively dealing with high risk products intended for import.

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