Pharma News

EMA’s human medicines committee (CHMP) is requesting as a matter of precaution that marketing authorisation holders for human medicines containing chemically synthesised active substances review their medicines for the possible presence of nitrosamines and test all products at risk. If nitrosamines are detected in any of their medicines, marketing authorisation holders must inform authorities promptly so that appropriate regulatory actions can be taken.

U.S. Food and Drug Administration released a suite of guidances to continue to encourage innovative approaches to the development of digital health tools, and to ensure the agency’s approach to overseeing these technologies advances along with it.
Patients, their families and their health care professionals are increasingly embracing digital health technologies to inform everyday decisions, from tools that more easily report blood glucose levels to smart watches that can detect atrial fibrillation. These tools provide patients with a wealth of easily-accessible information that can help them make better and more efficient decisions, take steps to improve their lifestyles and health choices, and experience better outcomes.

The U.S. Food and Drug Administration is alerting health care professionals and patients of a voluntary recall of 14 lots of prescription ranitidine capsules distributed by Sandoz Inc., used to decrease the amount of acid created by the stomach. This recall is due to a nitrosamine impurity, N-nitrosodimethylamine (NDMA), which was found in the recalled medicine. NDMA is classified as a probable human carcinogen (a substance that could cause cancer).

The National Institutes of Health has awarded approximately $35 million in new grants in fiscal year (FY) 2019 to advance research on Down syndrome through the Investigation of Co-occurring Conditions Across the Lifespan to Understand Down Syndrome (INCLUDE) project. These awards bolster total funding for Down syndrome research in FY 2019 to an estimated $77 million.

EMA has launched a new webpage that shows the progress made by the Agency in the implementation of the new Veterinary Medicines Regulation (Regulation (EU) 2019/6), which becomes applicable on 28 January 2022. On this webpage, stakeholders can find all relevant information regarding EMA’s scientific and technical recommendations to the European Commission that will feed into delegated and implementing acts as part of the implementation of the legislation, as well as updates on other activities such as the preparation for implementation progresses.

EMA’s Patients' and Consumers' Working Party (PCWP) has re-elected Kaisa Immonen of the European Patients' Forum (EPF) as co-chair and the Healthcare Professionals' Working Party (HCPWP) has elected Ulrich Jäger of the European Hematology Association (EHA) as new co-chair. They will co-chair the meetings of their respective working parties together with Juan Garcia Burgos, Head of Public Engagement at EMA, for the next three years. The vote took place during the September 2019 meeting of both working parties.

Addressing opioid overdose continues to be one of the most urgent public health priorities for the U.S. government and making potentially lifesaving treatments more readily available is one of the top ways we can address this crisis. As we observe Prescription Opioid and Heroin Epidemic Awareness Week, a time when we acknowledge the devastating toll the opioid crisis has inflicted on our country, we felt it was essential to clarify important information about naloxone, an emergency opioid overdose reversal treatment. Naloxone is a critical tool for individuals, families, first responders and communities to help reduce opioid overdose deaths.

The Committee recommended granting a marketing authorisation for Xospata* (gilteritinib) for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation. AML is a rare type of cancer of the white blood cells (cells that fight infections). It affects approximately 1 in 10,000 people in the European Union. Xospata was reviewed under EMA's accelerated assessment procedure, reserved for medicines of major public health interest.

U.S. Food and Drug Administration issued a proposed rule to set forth requirements related to the content, format and FDA’s review and communications procedures for premarket tobacco product applications (PMTAs) as part of the agency’s continued commitment to its oversight of e-cigarettes and other tobacco products. When finalized, this proposed rule will help to ensure that PMTAs contain sufficient information for evaluation such as details regarding the physical aspects of a tobacco product and information on the product’s potential public health benefits and harms. It also would codify the procedures by which the agency would review PMTAs and establish the requirements for manufacturers to maintain records related to the legal marketing status of their tobacco products.

Caption: L-R: Mr. Vivek Seigell, Principal Director, PHD Chamber, Mr. BhargavKotadia, Managing Director, Sahajanand Medical Technologies, Shri. D. V. SadanandaGowda,Hon’ble Minister of Chemicals & Fertilizers, Govt. of India, Dr. D. K. Aggarwal, Sr. Vice President, PHD Chamber, Dr. T. S. Kler, Chairman (Hospitals), Health Committee, PHD Chamber, Prof. Bejon Misra, Chairman, Public Health Committee, PHD Chamber and Dr Jitendar Sharma, Industry Expert- Medical Technologies