Tag Archive for: European Union

Vifor Pharma and partner Travere Therapeutics on Friday won an endorsement for approval from the European Union’s drug regulator for their drug Filspari, part of an industry race to treat a rare, serious kidney condition known as IgAN.

The European Union’s drug regulator will this week consider wider use of Novo Nordisk’s weight-loss drug Wegovy to include reducing the risk of strokes and heart attacks.

The healthcare industry is acutely aware of the elevated compliance concerns involved with artificial intelligence and machine learning, and its governing organizations are taking swift action to address these challenges. In fact, the latest guidelines proposed by international regulatory organizations such as the FDA, European Union (EU), and European Medicines Agency (EMA) are poised to reshape the lifesciences industry, especially for clinical trials.

It is the biggest change to existing medical laws in two decades, aiming to ensure all Europeans have access to innovative treatments and drugs.

The move follows a review that started in July and covered a range of drugs known as GLP-1 receptor agonists, also including Eli Lilly’s Trulicity, Sanofi’s Suliqua, AstraZeneca’s Bydureon and Novo’s Rybelsus and Saxenda.

Europe’s medicines regulator said on Friday its human medicines committee had recommended Eli Lilly’s diabetes drug Mounjaro also be approved as a weight-loss treatment.

The European Commission said the deal would not significantly reduce competition in the 27-country European Union nor would it have a negative impact on prices.

Regulators on both sides of the Atlantic have stepped up their scrutiny into the pharmaceutical industry to ensure that smaller innovative companies can compete with bigger rivals and that prices for drugs and products remain affordable.

The company stated that the European Union medicines regulator recommended a marketing authorization for the company’s drug Prevymis to treat a type of infection in adult kidney transplant recipients at high risk.

The European Union is expected to order the gene sequencing giant to divest Grail in the coming days, according to multiple media reports citing unnamed sources familiar with the matter.