Pharma News

USFDA has issued Form 483 with 10 observations for the Gundlamachnoor facility of Aurobindo Pharma.

The United States Food and Drug Administration (US FDA) inspected the Company Unit - IX, an intermediate facility situated at Gundlamachnoor Village, Sangareddy District, Telangana, from November 10 to November 18, 2022.

The U.S. Food and Drug Administration approved Tzield (teplizumab-mzwv) injection to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

Sun Pharmaceutical Industries Limited announced that the U.S. Food and Drug Administration (US FDA) has approved SEZABY  (phenobarbital sodium powder for injection) for the treatment of neonatal seizures. With this approval, SEZABY becomes the first and only product specifically indicated in the U.S. for the treatment of neonatal seizures in term and preterm infants. SEZABY is expected to be available in the U.S. in Q4FY23.

Strides Pharma Science Limited announced that its step-down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Potassium Chloride Oral Solution USP, 40 mEq/15mL (20%) from the United States Food & Drug Administration (USFDA).The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Potassium Chloride Oral Solution USP, 40 mEq/15 mL (20%) of Genus Lifesciences Inc.

Flu shots can save the lives of people with cardiovascular disease by reducing cardiac complications as well as preventing influenza.

An international study led by McMaster University researchers and published in The Lancet Global Health has found that influenza vaccines greatly reduce both pneumonia and cardiovascular complications in people with heart failure.

Enzymes, which are crucial to controlling how cells replicate in the human body, could be the very ingredient that encourages DNA to spontaneously mutate – causing potentially permanent genetic errors, according to new research from the University of Surrey.

Johns Hopkins Medicine researchers have revamped an anti-cancer drug to better target cancer cells and leave healthy tissues unharmed. Scientists have dubbed this type of targeted approach a “prodrug” — a medicine designed to release its payload in a particular area of the body and in no other areas. The Johns Hopkins-discovered prodrug, called DRP-104 (sirpiglenastat), is in early-stage clinical trials in people with advanced solid tumors.

Union Minister for Science and Technology Dr Jitendra Singh today said, India is among the top five countries in the world manufacturing life-saving high risk medical devices but the cost of our devices is about one-third of those manufactured by the other four countries.

On Monday, the Mumbai High Court directed the Maharashtra government to re-examine samples of Johnson & Johnson baby powder produced in government or government approved labs.

The division bench of Justices SV Gangapurwala and SG Dige asked additional government pleader Milind More to submit names of labs on November 16.