Pharma News

National Institutes of Health scientists and their collaborators found that hepatitis B virus (HBV)-associated acute liver failure (ALF) - a rare condition that can turn fatal within days without liver transplantation - results from an uncommon encounter between a highly mutated HBV variant and an unusual immune response in the patient’s liver that is mainly sustained by antibody-producing B cells. Their study is published in Proceedings of the National Academy of Sciences.

Antibiotic resistance is a growing threat to global health. As a result of infection with drug-resistant bacteria an estimated 700 000 people die each year worldwide. A total of around 33 000 die annually in the European Union and European Economic Area, and this number is increasing all the time.

The U.S. Food and Drug Administration has warned StemGenex Biologic Laboratories LLC (StemGenex) of San Diego, Calif; its owner/manager Rita F. Alexander and laboratory and medical director Jenny R. Galloway, M.D. about marketing a purported stem cell product without FDA approval and for significant deviations from current good manufacturing practice requirements, including some that could lead to microbial contamination, putting patients at risk.

New measures to overcome challenges in the response to the Ebola outbreak in the Democratic Republic of the Congo (DRC) are having a positive impact, although the outbreak remains dangerous and unpredictable, the United Nations Department of Peacekeeping and the World Health Organization (WHO) said after a joint mission to assess the outbreak.

Manufacturing inspections are one of the FDA’s most important tools for ensuring the quality of pharmaceutical products used by American patients. Inspections help us to identify manufacturing issues that could pose potential risks to patients, or problems that could contribute to drug shortages, enabling us to engage manufacturers to address and resolve issues.

U.S. Food and Drug Administration and the Department of Defense’s (DoD) Office of Health Affairs signed a Memorandum of Understanding regarding medical product development and assessment. This builds upon the work of both agencies to foster and prioritize the efficient development of safe and effective medical products intended to save the lives of American service members.

The National Pharmaceutical Pricing Authority (NPPA) has fixed/revised ceiling/retail prices of 68 scheduled formulations under Drugs (Prices Control) Order, 2013 in related notification dated November 2, 2018.

U.S. Food and Drug Administration permitted marketing of two devices that provide real-time location of parathyroid tissue during surgical procedures such as thyroidectomy (surgery to remove all or part of the thyroid) and parathyroidectomy (surgery to remove one or more parathyroid glands).

The National Toxicology Program (NTP) concluded there is clear evidence that male rats exposed to high levels of radio frequency radiation (RFR) like that used in 2G and 3G cell phones developed cancerous heart tumors, according to final reports released . There was also some evidence of tumors in the brain and adrenal gland of exposed male rats. For female rats, and male and female mice, the evidence was equivocal as to whether cancers observed were associated with exposure to RFR. The final reports represent the consensus of NTP and a panel of external scientific experts who reviewed the studies in March after draft reports were issued in February.