Pharma News

EMA’s human medicines committee (CHMP) has developed a paper to strengthen consistency when defining therapeutic indications in the product information of medicines. The document is intended to guide assessors in the national competent authorities who are responsible for evaluating marketing authorisation and extension of indication applications received by EMA. It outlines key elements that assessors should consider when evaluating the therapeutic indications proposed by the applicant, for example, whether a medicine is considered as first- or second-line treatment and whether it should be used in combination with another product. In this context, the paper takes into account some of the needs of healthcare decision-makers such as healthcare professionals and health technology assessment (HTA) bodies.

U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.

Machine learning’s powerful ability to detect patterns in complex data is revolutionizing how we drive, how we diagnose disease and now, how we discover new drugs. Scientists at Sanford Burnham Prebys Medical Discovery Institute have developed a machine-learning algorithm that gleans information from microscope images - allowing for high-throughput epigenetic drug screens that could unlock new treatments for cancer, heart disease, mental illness and more.

President of Gujarat state pharmacy council (GSPC), Mr. Montu Patel elected as member of Pharmacy council of India (PCI), Delhi. He became forth member from Gujarat to offer his services under PCI. Currently, Dr. NR Seth (Vice Chancellor, Gujarat Technological University), Dr. CN Patel (Professor & Principal, Shri Sarvajanik Pharmacy College, Mehsana) and Dr. HG Koshia (Commissioner, Food & Drugs Control Administration, Gujarat) are working members of PCI.

ITM SCHOOL OF PHARMACY, ITM (sls) BARODA UNIVERSITY, VADODARA has organized the GUJCOST sponsored National Seminar on “Nutraceuticals and Dietary Supplements: Unlimited Frontiers in Lifestyle Disorders & State Convention of Society of Pharmacognosy (Gujarat Chapter)”

Union Minister for Health & Family Welfare, Dr. Harsh Vardhan conferred the Indian Council of Medical Research (ICMR)'s awards for excellence in biomedical research .

The ICMR awards recognise the contributions of Indian biomedical scientists undertaking pioneering work in various fields of health sciences and finding solutions for the health problems of the country.

The U.S. Food and Drug Administration is alerting consumers of a voluntary recall by Johnson & Johnson of Johnson’s Baby Powder after FDA testing has found that a sample from one lot of the product contains chrysotile fibers, a type of asbestos. Consumers who have Johnson’s Baby Powder lot #22318RB should stop using it immediately and contact Johnson & Johnson for a refund. The FDA stands by the quality of its testing and results and is not aware of any adverse events relating to exposure to the lot of affected products.

With support from the National Institutes of Health’s Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative, scientists are developing powerful new devices and technologies to monitor and regulate brain activity. To ensure NIH keeps pace with rapid technological development and help clinicians and researchers ethically fit these new tools into practice, a paper recently published in JAMA Neurology highlights potential issues around and offers recommendations about clinical research with both invasive and noninvasive neural devices.

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation in the European Union for Ervebo (rVSVΔG-ZEBOV-GP), the first vaccine for active immunisation of individuals aged 18 years and older at risk of infection with the Ebola virus.

Affordable access to medicines is a public health concern and more generic drug competition can help reduce prices, improve access and benefit the public health. Safe, effective and high-quality generic drugs play a vital role in our health care system. Generic drugs account for about 90% of all prescription drug purchases in the U.S. In 2018, competition from generic drugs saved the health care system about $293 billion.