Pharma News

Zydus Lifesciences Limited U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Amantadine Extended-Release Capsules USP 68.5 mg and 137 mg (USRLD: Gocovri).

In a recent study, researchers from Xi’an Jiaotong-Liverpool University and other universities in China have reported that brain stimulation combined with a nose spray containing nanoparticles can improve recovery after ischemic stroke in an animal model.

Subject Expert Committee of CDSCO recommends to grant permission to Biocon to conduct phase 2 clinical trial for Itolizumab for Injection (r-DNA origin) 100 mg per vial.

Amylyx Pharmaceuticals, Inc announced that the U.S. Food and Drug Administration (FDA) has approved RELYVRIO (sodium phenylbutyrate and taurursodiol) for the treatment of adults with amyotrophic lateral sclerosis (ALS). RELYVRIO (previously known as AMX0035 in the U.S.) significantly slowed the loss of physical function in people living with ALS in a randomized, placebo-controlled clinical trial. RELYVRIO can be taken as a monotherapy or with existing approved treatments.

Demand for donor livers for transplant patients outstrips supply with over 15% of waitlist patients dying after a year. A new international study offers support for increasing the use of living donor liver transplantation (LDLT) in Western countries and reducing the imbalance between organ supply and demand. This study is reported in the Journal of Hepatology, the official journal of the European Association for the Study of the Liver, published by Elsevier.

Short cycles of a low-calorie diet that replicates fasting appeared to reduce inflammation and delay cognitive decline in mouse models of Alzheimer’s disease; initial data indicates diet’s safety in Alzheimer’s patients.

Researchers from the University of California, Los Angeles (UCLA) have developed a Zika vaccine technology that is highly effective and safe in preclinical mouse models. In a pregnant mouse model, the vaccine prevented both the pregnant mothers and the developing fetuses from developing systemic infection. The research is published in Microbiology Spectrum, a journal of the American Society for Microbiology.

Merck known as MSD outside of the United States and Canada, announced that KEYTRUDA, Merck’s anti-PD-1 therapy, received four new approvals from Japan’s Ministry of Health, Labor and Welfare (MHLW)

Lupin has received a warning letter from the USFDA for their Tarapur, Maharashtra facility. The U.S. FDA had inspected the Lupin Tarapur site from March 22, 2022 to April 4, 2022.

Initially, USFDA has closed the inspection at Lupin’s Tarapur manufacturing facility with four observations.