Pharma News

The Subject Expert Committee (SEC) on Gastroenterology and Hepatology has declined to recommend approval of a Fixed Dose Combination (FDC) containing Dexlansoprazole (enteric coated pellets) 60 mg and Domperidone (sustained release pellets) 30 mg capsules proposed by MSN Laboratories Private Limited.

The decision was taken during the 08th/26 SEC meeting held on 9 July 2026 at the CDSCO Headquarters, New Delhi, after the company presented its proposal before the committee.

Merck has announced that the US Food and Drug Administration (FDA) has approved LIPFENDRA® (enlicitide) 20 mg, making it the first and only once-daily oral PCSK9 inhibitor for lowering low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia, including those with heterozygous familial hypercholesterolemia (HeFH). The approval marks the first oral alternative to injectable PCSK9 inhibitors.

Novartis has announced that the US Food and Drug Administration (FDA) has granted traditional approval to Fabhalta® (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression. The decision follows the drug's accelerated approval in August 2024, which was based on its ability to reduce proteinuria.

A comprehensive systematic review and meta-analysis published in the journal BIO Integration has found that routine vitamin D supplementation during pregnancy does not provide convincing evidence for preventing preterm birth. The analysis also highlighted that an apparent increase in preterm birth risk observed in one subgroup should be interpreted with caution because it was driven by a single clinical trial involving women living with HIV, rather than the broader pregnant population.

The Gujarat State Pharmacy Council (GSPC) has partnered with the Indian Pharmacopoeia Commission (IPC) to launch a dedicated "Pharmacovigilance & Medicine Safety" to strengthen medicine safety awareness and promote adverse drug reaction (ADR) reporting

Novo Nordisk has announced that the European Commission (EC) has approved Wegovy® (semaglutide) tablets for chronic weight management, making it the first oral GLP-1 receptor agonist authorized in the European Union for the treatment of obesity and overweight. The approval also includes a single, ready-to-use 7.2 mg Wegovy injection pen, providing healthcare professionals and patients with additional treatment options.

Sanofi has filed a patent infringement lawsuit against Moderna in the U.S. District Court for the District of New Jersey, alleging that Moderna's mRNA vaccine technologies infringe a portfolio of patents originally developed by Translate Bio, a biotechnology company acquired by Sanofi in 2021. The complaint names Translate Bio, Translate Bio MA, Sanofi Vaccines US, and VaxServe as plaintiffs, while Moderna, ModernaTX, and Moderna US are listed as defendants.