Pharma News

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.

Drugs such as Ozempic and other GLP-1 receptor agonists, widely known for their effects on diabetes and weight management, may have potential beyond appetite control, with emerging research suggesting they could also help reduce cravings associated with addiction. A recent report published by The Conversation highlights new evidence pointing to a specific brain pathway that may explain how these medicines influence reward-driven behaviours.

The Subject Expert Committee (Oncology) of the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission to conduct a Phase IV clinical trial of dostarlimab in adult patients in India with primary advanced or recurrent endometrial cancer. The recommendation was made during the SEC (Oncology) meeting held on August 5, 2026, at CDSCO Headquarters, New Delhi.

The Central Drugs Standard Control Organisation (CDSCO) has clarified that applications seeking permission to import and market new drugs that are not approved anywhere in the world, where Phase III Global Clinical Trials (GCTs) are either ongoing or have been completed with the participation of Indian subjects, will be examined and processed by the Investigational New Drug (IND) Division.

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.

As cancer treatments continue to improve survival rates, managing treatment-related side effects remains one of the biggest challenges in oncology. A new scientific review has highlighted the significant role of circular RNAs (circRNAs) in understanding and potentially reducing the toxic effects associated with chemotherapy, radiotherapy, and immunotherapy.

A team of researchers from Japan has uncovered a previously unknown immune mechanism that helps explain how allergies that begin in the skin can progress into severe, body-wide allergic reactions. The discovery sheds light on the biological events underlying the "atopic march" and could pave the way for new therapies aimed at preventing life-threatening allergic conditions.

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.