Pharma News

Pharma major Lupin Limited (Lupin) announced the successful close out of the inspection carried out by the Medicines and Healthcare products Regulatory Agency (MHRA), the regulatory agency of the United Kingdom (UK), at its three manufacturing units in Pithampur (India). The inspection for the three units at Pithampur (Unit I, Unit II and Unit III) was conducted in January 2020.

The PM took a detailed review of the current status of India’s efforts in vaccine development, drug discovery, diagnosis and testing. Indian vaccine companies are well known for their quality, manufacturing capacity and global presence. Today in addition, they have come across as innovators in early stage vaccine development research. Similarly, Indian academia and start-ups have also pioneered in this area. Over 30 Indian vaccines are in different stages of corona vaccine development, with a few going on to the trial stages.

Health Minister Sh. Harsh Vardhan and Minister of State for AYUSH  Sh. Shripad Yesso Naik jointly launched clinical research studies on Ayurveda interventions as an add-on to standard care to COVID 19 situation and Ayush Sanjivani application today at New Delhi. AYUSH Minister was participating in the programme through Video Conferencing from Goa.

Pfizer Inc and BioNTech SE announced that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week.

In spite of problems in procurement & logistics due to COVID-19 lockdown, Pradhanmantri  Bhartiya Jan aushadhi Kendras –PMBJAK ,achieved a record sales turnover of  52 crore rupees in the month of April  2020 compared to 42 crore rupees in March 2020. It was 17 crore in April 2019.

Gilead Sciences, Inc. announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Veklury® (remdesivir) as a treatment for SARS-CoV-2 infection, the virus that causes COVID-19, under an exceptional approval pathway. The exceptional approval was granted due to the COVID-19 pandemic and references the Emergency Use Authorization of remdesivir in the United States.

U.S. Food and Drug Administration issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.

The U.S. Food and Drug Administration  granted marketing authorization for a new device indicated to provide continuous hemodialysis or hemofiltration therapy to critically ill pediatric patients weighing between 2.5 and 10 kilograms (or 5.5 to 22 pounds). Continuous hemodialysis or hemofiltration therapy – known as continuous renal replacement therapy (CRRT) – involves using a dialysis machine and a special filter, or dialyzer, to continuously clean a patient’s blood for an extended period of time, without stopping, instead of the more traditional three times a week therapy session. CRRT is typically performed in intensive care unit (ICU) settings. The CARPEDIEM System is the first CRRT device intended for a lower weight-specific pediatric patient population (2.5 and 10 kilograms; or 5.5 to 22 pounds) who have a sudden or temporary loss of kidney function (acute kidney injury) or have too much water in their bodies because their kidneys are not functioning properly (fluid overload).

The U.S. Food and Drug Administration included, under the ventilator emergency use authorization (EUA), a ventilator developed by the National Aeronautics and Space Administration (NASA), which is tailored to treat patients with COVID-19. The ventilator was added to the list of authorized ventilators, ventilator tubing connectors and ventilator accessories under the ventilator EUA that was issued in response to concerns relating to insufficient supply and availability of FDA-cleared ventilators for use in health care settings to treat patients during the COVID-19 pandemic.

In a high-level meeting on COVID-19 policies, organised by EMA under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA), international regulators from around the world discussed strategic issues and regulatory approaches to ensure a coordinated response to the pandemic. They stressed the need for alignment on pre- and post-authorisation regulatory requirements to facilitate the rapid development, evaluation and availability of medicines for the treatment and prevention of coronavirus disease.