Pharma News

The U.S. Food and Drug Administration (FDA) has approved a new indication for Pfizer's IBRANCE (palbociclib), allowing its use in combination with trastuzumab, with or without pertuzumab, and endocrine therapy as maintenance treatment for adults with hormone receptor-positive (HR+), HER2-positive (HER2+) locally advanced or metastatic breast cancer following induction therapy. The approval marks a significant expansion for the widely used CDK4/6 inhibitor.

The World Health Organization (WHO) has taken another significant step toward strengthening the quality, safety, and regulation of herbal medicines by advancing the development of an International Herbal Pharmacopoeia (IHP). During the 5th WHO Expert Meeting held in Hong Kong SAR (China) from 16–18 June 2026, experts from all six WHO regions met to accelerate the creation of globally harmonized standards for herbal medicines.

The European Union has awarded 15 million euro under its Horizon Europe research and innovation program to launch REPhRAME, an ambitious international project aimed at developing a new treatment strategy for recurrent urinary tract infections (UTIs). Coordinated by Universitätsmedizin Frankfurt under the leadership of Prof. Dr. Maria J.G.T. Vehreschild, the five-year project will evaluate phage therapy as a potential alternative to antibiotics in patients suffering from recurrent bacterial infections.

Researchers from Chiba University, Japan, have identified a promising strategy that could help prevent cancer from returning after treatment with KRAS-targeted drugs. The study reveals that a small population of cancer cells, known as drug-tolerant persister cells (DTPs), survives KRAS inhibitor therapy by rewiring its metabolism. By targeting these newly discovered survival mechanisms, scientists believe it may be possible to eliminate these residual cells and reduce the risk of relapse.

The Central Drugs Standard Control Organisation (CDSCO) has released its monthly drug quality alert for May 2026, identifying 157 drug samples as Not of Standard Quality (NSQ) and 2 drug samples as Spurious following testing by Central and State Drug Testing Laboratories across the country. The findings underscore the importance of continuous post-marketing surveillance to ensure the quality, safety and efficacy of medicines available to patients.

Sun Pharmaceutical Industries Ltd. has announced the acquisition of Innovcare Lifesciences Private Limited. The deal, valued at approximately ₹271.2 crore, will give Sun Pharma complete ownership of the Mumbai-based healthcare company.

The Subject Expert Committee (SEC) on Antimicrobial & Antiparasitic has asked M/s Emcure Pharmaceuticals Limited to revise its proposed Active Post-Marketing Surveillance (PMS) protocol for Liposomal Amphotericin B Injection 50 mg/vial (Lyophilized) before it can be considered further.

The recommendation was made during the 6th SEC (Antimicrobial & Antiparasitic) meeting of 2026, held on June 11, 2026, at the Central Drugs Standard Control Organization (CDSCO) headquarters in New Delhi.

In a significant development in the biosimilar segment, the Subject Expert Committee (SEC) on Dermatology & Allergy has recommended granting permission to M/s Kemwell Biopharma Private Limited to conduct a comparative pharmacokinetic clinical study for its proposed Dupilumab biosimilar, ASP100.

The recommendation was made during the 6th SEC (Dermatology & Allergy) meeting of 2026, held on June 11, 2026, at the CDSCO Headquarters in New Delhi.