Pharma News

Lupin Limited has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (US FDA) for its Ankleshwar manufacturing facility, located in Gujarat, India.

The inspection of the facility was conducted from August 16-19, 2022 by USFDA. Lupin is the third largest pharmaceutical company in the U.S. by prescriptions. The company invested 9.6% of its revenue on research and development in FY21.

Simple nasal washes with mild saline water can prevent hospitalisation and deaths from COVID-19, if applied twice daily following a positive diagnosis, according to research led by the US-based Augusta University.

Epileptic seizures are frequent among patients with cerebral venous thrombosis - a blood clot affecting the venous system of the brain. A thesis from University of Gothenburg suggests that some of these patients should be diagnosed with epilepsy and offered medication to prevent further seizures.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

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.