Pharma News

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.

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.

Dr. Reddy’s Laboratories has received approval from the U.S. Food and Drug Administration (FDA) for its rituximab biosimilar, a biosimilar version of Rituxan® (rituximab), marking another significant milestone in the company's expanding global biosimilars business.

The approval enhances Dr. Reddy’s biologics portfolio and reinforces its presence in the highly regulated U.S. pharmaceutical market. The biosimilar was developed, manufactured, and submitted for approval entirely by Dr. Reddy’s Laboratories.

AstraZeneca Plc has held discussions with U.S.-based Bristol Myers Squibb (BMS) over a potential merger that could create one of the world's largest pharmaceutical companies with a combined market value of nearly $400 billion, according to an exclusive report by the Financial Times, which cited people familiar with the matter.