Pharma News

First antidote for reversal of anticoagulation with factor Xa inhibitors apixaban and rivaroxaban

  • Posted on: 4 March 2019
  • By: Shalini.Sharma

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisationin the European Union for Ondexxya (andexanet alfa). This medicine is to be used as an antidote for adult patients taking the anticoagulant (clot-preventing) medicines apixaban or rivaroxaban, when reversal of their action is needed due to life-threatening or uncontrolled bleeding.

FDA, CDC, and CMS launch task force to help facilitate rapid availability of diagnostic tests during public health emergencies

  • Posted on: 1 March 2019
  • By: Shalini.Sharma

U.S. Food and Drug Administration, Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) announced the launch of the Tri-Agency Task Force for Emergency Diagnostics. This task force has been created to help leverage the expertise of each agency to advance rapid development and deployment of diagnostic tests in clinical and public health laboratories during public health emergencies.

Significant Reduction in Cancer Drug Prices due to Trade Margin Capping

  • Posted on: 1 March 2019
  • By: Shalini.Sharma

Cancer is one of the leading causes of adult illness and death due to chronic non-communicable diseases in India.   India is witnessing a steady rise in cancer incidence.  The number of incident-cases has risen from 8 lakh in 2004 to an estimated 15 lakh (annually) by 2018.  Even with nearly two third of patients eventually dying of this disease, an estimated 22.5 lakh patients are currently living with cancer in India.

FDA advances new proposed regulation to make sure that sunscreens are safe and effective

  • Posted on: 22 February 2019
  • By: Shalini.Sharma

The U.S. Food and Drug Administration issued a proposed rule that would update regulatory requirements for most sunscreen products in the United States.

This significant action is aimed at bringing nonprescription, over-the-counter (OTC) sunscreens that are marketed without FDA-approved applications up to date with the latest science to better ensure consumers have access to safe and effective preventative sun care options. Among its provisions, the proposal addresses sunscreen active ingredient safety, dosage forms, and sun protection factor (SPF) and broad-spectrum requirements. It also proposes updates to how products are labeled to make it easier for consumers to identify key product information.

EU and Switzerland to improve information-sharing on good manufacturing practice through use of the EudraGMDP database

  • Posted on: 22 February 2019
  • By: Shalini.Sharma

The Swiss Agency for Therapeutic Products (Swissmedic) has started in 2019 to enter information on Good manufacturing practice (GMP) compliance as well as on manufacturing authorisations related to Swiss manufacturers into the European Union’s EudraGMDP database. This applies for all new or renewed manufacturing authorisations and the related GMP-certificates issued using new templates (similar to those of EMA). This will allow replacing the current practice of issuing paper documents, i.e. GMP certificates for certain regulatory procedures and therefore should lead to easier information-sharing and efficiency gains for all stakeholders.

Nitisinone increases melanin in people with albinism: Study

  • Posted on: 22 February 2019
  • By: Shalini.Sharma

A small pilot clinical study at the National Eye Institute (NEI) suggests that the drug nitisinone increases melanin production in some people with oculocutaneous albinism type 1B (OCA-1B), a rare genetic disease that causes pale skin and hair and poor vision. Increased melanin could help protect people with the condition against the sun’s UV rays and promote the development of normal vision. Study results were published in JCI Insight. NEI is part of the National Institutes of Health (NIH).

Countries are spending more on health, but people are still paying too much out of their own pockets : WHO

  • Posted on: 22 February 2019
  • By: Shalini.Sharma

Health spending is made up of government expenditure, out-of-pocket payments (people paying for their own care), and sources such as voluntary health insurance, employer-provided health programmes, and activities by non-governmental organizations.

Pages