Pharma News

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has stopped administration of vaccinations in its HVTN 702 clinical trial of an investigational HIV vaccine. This action was taken because an independent data and safety monitoring board (DSMB) found during an interim review that the regimen did not prevent HIV. Importantly, the DSMB did not express any concern regarding participant safety.

Homicide is a leading cause of death among pregnant and postpartum women in Louisiana, according to an analysis of birth and death records from 2016 and 2017. The study, appearing as a research letter in JAMA Pediatrics, was funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health. The research team was led by Maeve E. Wallace, Ph.D., of Tulane University School of Public Health and Tropical Medicine in New Orleans.

The U.S. Food and Drug Administration and the Federal Trade Commission today signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products, including the critical adoption of biosimilars and interchangeable products. This joint statement describes key steps the agencies will take to address false or misleading promotion about biosimilars within their respective authorities and deter anti-competitive behavior in this space.

Eminence Business Media’s “3rd Annual Pharma Project & Portfolio Management Summit 2020” concluded on January 23rd & 24th, 2020 at Hotel Hilton, Mumbai. The theme of the summit was “Grooming Project & Portfolio Management teams for opportunities & uncertainties”. The event was an outstanding success with 100+ delegates attending the summit with I2E Consulting, Innoventic Research & Business & ProductDossier Solutions India Pvt. Ltd. partnering the event.

Eminence Business Media organized “Pharma Authors Roundtable” on January 22nd, 2020 at Hotel JW Marriott, Mumbai inviting all the young writers & authors to present their ideas, success stories, case studies on how did they manage/handle a project successfully. This event was Eminence Business Media’s initiative towards creating a platform for established & new authors to get their names featured as the co-author of an upcoming book on project management by Mr. John Robert.

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.