Pharma News

Council of Scientific and Industrial Research- Central Drug Research Institute (CSIR-CDRI) have signed an agreement for collaboration to jointly develop new drugs for treating various medical conditions and repurposing of drugs for India and global markets with Cipla Limited.

Indian Pharmacopoeia has been recognised formally by the National Department of Regulation of Medicines and Health Products of the Ministry of Public Health of Islamic Republic of Afghanistan. The quality, efficacy and safety of the medicines are important from healthcare prospective. In order to ensure the quality of medicinal products, the legal and scientific standards are provided by Indian Pharmacopoeia Commission (IPC) in the form of Indian Pharmacopoeia (IP).

U.S. Food and Drug Administration and the Drug Enforcement Administration (DEA) announced that they have seized 44 websites advertising the sale of illicit vaping cartridges containing tetrahydrocannabinol (THC), the primary psychoactive component of the cannabis plant. The action, which is part of Operation Vapor Lock, reflects ongoing work by federal, state and local authorities to investigate the supply chain of vaping products associated with recent lung injuries.

An experimental Zika vaccine lowered levels of virus in pregnant monkeys and improved fetal outcomes in a rhesus macaque model of congenital Zika virus infection, according to a new study in Science Translational Medicine. The research was conducted by scientists at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and their collaborators from the University of California, Davis; Duke University, Durham, North Carolina; and the University of California, Los Angeles. NIAID scientists developed the experimental vaccine and currently are evaluating it in a Phase 2 human clinical trial. The vaccine uses a small circular piece of DNA, or plasmid, containing genes that encode Zika virus surface proteins to induce an immune response.

U.S. Food and Drug Administration granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. Enhertu is a human epidermal growth factor receptor 2 (HER2)-directed antibody and topoisomerase inhibitor conjugate, meaning that the drug targets the changes in HER2 that help the cancer grow, divide and spread, and is linked to a topoisomerise inhibitor, which is a chemical compound that is toxic to cancer cells.

Gilead Sciences, Inc announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis (RA). A priority review voucher was submitted with the NDA, shortening the anticipated time for review.

Compounded drugs can serve an important role in meeting patients’ medical needs that cannot be met by an FDA-approved drug. Outsourcing facilities, a significant part of the industry producing compounded drugs used by hospitals, clinics, providers, and other health care systems, have rapidly evolved since the passage of the Drug Quality and Security Act (DQSA) in 2013. Although compounded drugs can fill an important role for patients and the FDA recognizes the need to preserve access to these products, they may also present a greater risk to patients because, among other things, they are not required to undergo the agency’s premarket review for safety, effectiveness and quality. These risks have become evident during inspections of outsourcing facilities when the agency has found concerning production practices that have resulted in recalls of compounded drug products and enforcement action against some firms.

World Health Organization (WHO) prequalified its first biosimilar medicine – trastuzumab – in a move that could make this expensive, life-saving treatment more affordable and available to women globally.

The number of cholera cases decreased globally by 60% in 2018, the World Health Organization (WHO) announced in a report that points to an encouraging trend in cholera prevention and control in the world’s major cholera hotspots, including Haiti, Somalia and the Democratic Republic of the Congo.

EMA and its European and international partners are launching a pilot programme to increase their cooperation in the inspection of manufacturers of sterile medicines for human use. This new initiative is built on the success of and experience gained from a similar collaboration, the international active pharmaceutical ingredients (APIs) inspection programme.