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  • U.S. Food and Drug Administration announced the launch of an interactive database that will offer a wealth of critical information about antiretrovirals (ARVs) eligible for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program. This launch is an important step in our ongoing commitment to address the global HIV epidemic and is consistent with our efforts to modernize and improve access to information and unleash the power of data.

  • U.S. Food and Drug Administration (FDA) announced critical actions to advance development of novel coronavirus medical countermeasures.

    As with any emerging public health threat, the FDA will collaborate with interagency partners, product developers, international partners and global regulators to expedite the development and availability of medical products needed to diagnose, treat, mitigate and prevent such outbreaks.

  • A Phase 1 clinical trial testing the safety and effectiveness of a monoclonal antibody (mAb) against malaria has begun enrolling healthy adult volunteers at the National Institutes of Health Clinical Center in Bethesda, Maryland. The trial, sponsored by NIH’s National Institute of Allergy and Infectious Diseases (NIAID), is the first to test mAb CIS43LS in humans. It aims to enroll up to 73 volunteers aged 18 through 50 years old who have never had malaria. After receiving mAb CIS43LS, most of the volunteers will be exposed to malaria parasite-carrying mosquitoes under carefully controlled conditions at the Walter Reed National Military Medical Center in Bethesda to assess the ability of the mAb to confer protection from malaria infection.

  • Scientists from The Peter Doherty Institute for Infection and Immunity (Doherty Institute) in Melbourne have successfully grown the Wuhan coronavirus from a patient sample, which will provide expert international laboratories with crucial information to help combat the virus.

  • Tuberculosis kills. When it doesn’t, its effect stays for what is a lifetime. To make things worse, the current approach for treating TB consumes a lot of time. This puts pressure on TB control programmes. Here are some figures from World Health Organization’s website – 1.5 million people died of TB in 2018; an estimated 10 million fell ill with TB worldwide and alarmingly – among the eight countries that account for two-thirds of the TB cases, India has the most number of cases. 

  • Piramal Enterprises Limited’s Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), announced plans to expand its Aurora facility in Canada with the addition of a new state-of-the-art wing dedicated to manufacturing Active Pharmaceutical Ingredients (APIs). A total investment of ~CAD$25 million will be infused towards this expansion.

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