Pharma News

The U.S. Food and Drug Administration has requested that all current manufacturers of bacitracin for injection voluntarily withdraw their product from the market. Bacitracin for injection is currently FDA-approved to treat infants with pneumonia and empyema (a collection of pus in the space between the membranes lining the lungs) caused by staphylococci, a type of bacteria, shown to be susceptible to the drug.

Gilead is working closely with global health authorities to respond to the novel coronavirus (2019-nCoV) outbreak through the appropriate experimental use of our investigational compound remdesivir. Together with the U.S. Food and Drug Administration (FDA), the U.S. Centers for Disease Control and Prevention (CDC), the U.S. Department of Health and Human Services (DHHS), the China CDC and National Medical Product Administration (NMPA), the World Health Organization (WHO), and the U.S. National Institute of Allergies and Infectious Diseases (NIAID), and along with individual researchers and clinicians, Gilead is focused on contributing our antiviral expertise and resources to help patients and communities fighting 2019-nCoV.

This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world. To date, the FDA has approved four gene therapy products, which insert new genetic material into a patient’s cells. The agency anticipates many more approvals in the coming years, as evidenced by the more than 900 investigational new drug (IND) applications for ongoing clinical studies in this area. The FDA believes this will provide patients and providers with increased therapeutic choices.

The Director-General of the World Health Organization (WHO), Dr Tedros Adhanom Ghebreyesus, today met President Xi Jinping of the People’s Republic of China in Beijing. They shared the latest information on the novel coronavirus 2019 (2019-nCoV) outbreak and reiterated their commitment to bring it under control.

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.

For a long time Gujarat State Pharmacy Council (GSPC) had been receiving so many doubtful applications for registration of pharmacist. There were so many irregularities found in studies, study after a long age gap, and 10th and 12th science done from UP board or Open Board and the taking admission in Diploma Pharmacy.

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.

The Central Drugs Standard Control Organisation (CDSCO) has released the list of 139 drug formulations and their reference products permitted by DCGI to conduct bio-equivalence (BE) studies.

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.