Pharma News

The U.S. Food and Drug Administration approved Tibsovo (ivosidenib) tablets for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first drug in its class (IDH1 inhibitors) and is approved for use with an FDA-approved companion diagnostic used to detect specific mutations in the IDH1 gene in patients with AML.

U.S. Food and Drug Administration is working to address the opioid epidemic is by encouraging the development of opioid analgesic products that are harder to manipulate and abuse. Opioids with abuse-deterrent formulations (ADFs) are intended to make certain types of abuse, such as crushing a tablet to snort or dissolving a capsule to inject, more difficult or less rewarding.

Gestational diabetes may increase the risk of blood vessel dysfunction and heart disease in offspring by altering a smooth muscle protein responsible for blood vessel network formation. Understanding of the protein's function in fetal cells may improve early detection of disease in children. The study is published ahead of print in the American Journal of Physiology--Cell Physiology.

Women who eat a high amount of fruits and vegetables each day may have a lower risk of breast cancer, especially of aggressive tumors, than those who eat fewer fruits and vegetables, according to a new study led by researchers from Harvard T.H. Chan School of Public Health. In their findings, cruciferous vegetables such as broccoli, and yellow and orange vegetables, had a particularly significant association with lower breast cancer risk.

A drug currently in clinical trials for treating symptoms of Parkinson's disease may someday have value for treating heart failure, according to results of early animal studies by Johns Hopkins Medicine researchers.

People infected with HIV are twice as likely to suffer from heart disease, research has found.

Analysis of global figures reveals that HIV-associated cardiovascular disease has more than tripled in the past 20 years as more people are living longer with the virus.

Sun Pharmaceutical Industries Ltd announced that it has received approval from the U.S. Food and Drug Administration (USFDA) for INFUGEM™ (gemcitabine in 0.9% sodium chloride injection) 10 mg/mL, for intravenous use in a ready-to-administer (RTA) bag. This is the first USFDA approval for a product from Sun Pharma’s Halol facility post receipt of Establishment Inspection Report (EIR) in June 2018.

FDA considering all options for positively impacting both access and the cost of health care. FDA announcing a new effort to establish innovative approaches to increase access to a broader selection of nonprescription drug products for consumers, empowering them to self-treat common conditions and potentially some chronic conditions.

The Union Cabinet chaired by the Prime Minister Shri Narendra Modi has given its ex-post facto approval for the Memorandum of Understanding (MoU) between the Central Drugs Standard Control Organization (CDSCO), India and National Agency for Drug and Food Control (BPOM), Indonesia on cooperation in the field of pharmaceutical products, pharmaceutical substances, biological product and cosmetics regulatory functions.
The MoU was on signed on 29th May, 2018 in Jakarta.

The Union Cabinet chaired by Prime Minister Shri Narendra Modi has given its ex-post facto approval for the Memorandum of Understanding (MoU) between India and Cuba on cooperation in the field of Traditional Systems of Medicine and Homeopathy.  The MoU was signed on 22.6.2018.