Pharma News

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.

The National Institutes of Health will fund the collection of information from women with disabilities who give birth in the United States to supplement the Pregnancy Risk Assessment Monitoring System (PRAMS).

ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level.

The transmission speed of neurons fluctuates in the brain to achieve an optimal flow of information required for day-to-day activities, according to a National Institutes of Health study. The results, appearing in PNAS, suggest that brain cells called astrocytes alter the transmission speed of neurons by changing the thickness of myelin, an insulation material, and the width of gaps in myelin called nodes of Ranvier, which amplify signals.

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A new study puts a fresh spin on what it means to “go with your gut.” The findings, published in Nature, suggest that gut bacteria may control movement in fruit flies and identify the neurons involved in this response. The study was supported by the National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health.

The task force set up by EMA and the Heads of Medicines Agencies (HMA) on availability of authorised human and veterinary medicines is organising a two-day workshop (8-9 November 2018) at EMA in London to gather stakeholders' perspectives on how to better address potential problems with the supply of medicines and how to avoid shortages of medicines.

Innovations in plant and animal biotechnology offer tremendous opportunities for advancing public health. Promising new technologies that can edit animal and plant genomes have the potential to improve human and animal health, animal well-being, food productivity and food security. New forms of biotechnology allow modification of living organisms, such as plants or animals, in order to produce a new product, such as a novel pharmaceutical, new food variety or disease-resistant crop. These are just some of the new plant and animal-based biotechnology innovations that are opening up new opportunities to improve public health.