Industry News

Zydus Lifesciences has announced positive topline results from its global EVIDENCES-X™ Phase II(b) clinical trial evaluating Saroglitazar Magnesium in patients with Metabolic dysfunction-Associated Steatohepatitis (MASH) and fibrosis. The company said the study successfully achieved its primary endpoint, marking an important milestone in its ongoing MASH development programme.

The Trump administration has announced agreements with nine additional pharmaceutical manufacturers aimed at reducing prescription drug prices in the United States under its Most-Favored-Nation (MFN) pricing initiative.

The latest agreements bring the total number of pharmaceutical manufacturers participating in the administration's MFN arrangements to 26 companies, covering approximately 89% of the branded drug market, according to a White House fact sheet released on August 31.

A routine inspection by the United States Food and Drug Administration (US FDA) at Lannett Company LLC, a wholly owned step-down subsidiary of Aurobindo Pharma USA, Inc., has concluded with four observations.

The inspection was conducted at Lannett Company’s manufacturing facility in Seymour, Indiana, USA, from August 17 to August 21, 2026. According to the company’s regulatory filing, the inspection was carried out as part of the US FDA’s routine inspection process.

The U.S. Food and Drug Administration (FDA) has issued a warning letter to Dabur India Limited following an inspection of the company’s drug manufacturing facility in Saily, Silvassa, Dadra and Nagar Haveli and Daman and Diu, India. The inspection, conducted from January 12 to 16, 2026, identified significant violations of Current Good Manufacturing Practice (CGMP) requirements for finished pharmaceuticals.

Biophore has announced that it has entered into a definitive agreement with Par Health to acquire an FDA-approved sterile injectable manufacturing facility in Indore, India.

MSN has announced the successful launch of its Teduglutide Injection across several key European markets, marking a significant milestone in the company’s development of complex peptide medicines.

The launch is based on the dossier developed by MSN following the first generic approval for Teduglutide in Europe. According to the company, the achievement also makes MSN the first company to secure approval for a generic Teduglutide dossier in a G7 nation.

Amgen Inc. has disclosed a material cybersecurity incident after identifying unauthorized activity involving data stored in cloud environments hosted by third-party service providers. The company revealed the incident in a Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (SEC).

According to the filing, Amgen detected the unauthorized activity in July 2026 and immediately activated its cybersecurity incident response plan. The company implemented containment measures and engaged independent cybersecurity forensic experts to investigate the breach.

Sandoz has announced significant progress in resolving long-standing U.S. litigation related to the generic medicines market, entering into settlement agreements covering the majority of its remaining legacy antitrust cases in the United States. The company stated that the agreements are intended to resolve historical legal disputes while allowing it to remain focused on its core business of expanding access to affordable medicines.