Pharma News

During  their last investigation in April 2013 at Canton Laboratories- Vadodara,  U.S. food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs) and in view of it, FDA issued a warning letter.

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U.S. Food and Drug Administration allowed marketing of the first device, Cefaly-manufactured by STX-Med in Belgium, as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.

A blood test that can predict with 90 percent accuracy if a healthy person will develop mild cognitive impairment (MCI) or Alzheimer’s disease (AD) within three years has been discovered and validated by researchers at Georgetown and six other institutions. They discovered and validated 10 lipid biomarkers out of which 2 are strongly associated with neuropathology of AD.

A team of University of Notre Dame researchers led by Mayland Chang and Shahriar Mobashery have discovered a new class of antibiotics to fight bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and other drug-resistant bacteria that threaten public health.

Synthetic Biologics, Inc., a developer of anti-infective biologic and drug candidates targeting specific pathogens that cause serious infections and other diseases, announced today that the U.S. Patent & Trademark Office has issued U.S. Patent No. 8,658,627 entitled, Pregnancy Hormone Combination for Treatment of Autoimmune Diseases, to the Regents of the University of California (UCLA).

Novel biological markers have discovered by researchers from Finland and Estonia  that are strongly indicative of risk of dying from any disease within the near future. Blood samples from over 17000 generally healthy people were screened for more than a hundred different biomolecules. The health status of these study volunteers was followed for several years. The researchers looked for measures in the blood that could reflect who had died within the following 5 years after the blood sample was taken. In a study published in PLOS Medicine, they describe identification of four such biomarkers of death.

A new "cluster" have set up on medicinal safety topics by join efforts of U.S. Food and Drug Administration and the European Medicines Agency (EMA). Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration.

Basic guidelines for stem cell research were released in 2007 by joint efforts of DBT & ICMR which are revised in December 2013 after evaluating development in field of stem cell research. These newer guidelines are termed as 'National Guidelines for Stem Cell Research'.

The expert committee submitted report to ministry of health and family welfare, Government of India on amendment of relevant rules in the Drugs and Cosmetics Act 1940 to include stem cells and other cell based products (SCCPs) as New Drugs.