Pharma News

Rubicon Research Limited has received one observation in a Form 483 issued by the United States Food and Drug Administration (US FDA) following an unannounced inspection of its manufacturing facility in Satara, Maharashtra.

Solid tumors are not merely collections of malignant cells but complex ecosystems comprising tumor cells, stromal cells, and the extracellular matrix (ECM). The tumor microenvironment (TME) fosters immunosuppression through tumor-associated macrophages (TAMs), myeloid-derived suppressor cells (MDSCs), regulatory T cells (Tregs), and cancer-associated fibroblasts (CAFs), while physical barriers such as dense ECM and abnormal vasculature hinder drug penetration

The U.S. Food and Drug Administration (FDA) has approved HOVILPRI (pritelivir) tablets for the treatment of mucocutaneous lesions caused by herpes simplex virus (HSV) infection in immunocompromised adults whose infections have not responded to standard antiviral treatments.

Viatris Inc. has agreed to acquire Pacira BioSciences Inc. in an all-cash transaction valued at approximately 1.65 billion USD, marking a significant step in its strategy to expand its innovative medicines business.

Pfizer has announced that the US Food and Drug Administration (FDA) has approved TUKYSA (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of adults with unresectable locally advanced or metastatic HER2-positive breast cancer following induction treatment.

Bristol Myers Squibb (BMS) has announced positive results from its Phase III EXCALIBER-RRMM study, demonstrating superior progression-free survival with ZENBEXUS (iberdomide) in combination with daratumumab and dexamethasone in patients with relapsed or refractory multiple myeloma.

Roche has announced that the US Food and Drug Administration (FDA) has approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), in combination with a fluoropyrimidine and oxaliplatin, for the adjuvant treatment of stage III deficient mismatch repair (dMMR) colon cancer.

The government has approved a 30% cap on trade margins for non-scheduled anti-cancer medicines, aiming to reduce medicine prices by up to 70% and provide annual savings of ₹2,500 crore to cancer patients.

Halozyme Therapeutics is strengthening its position in subcutaneous drug delivery through two developments announced within a day of each other : a Dutch court ruling that restricts Merck’s Keytruda SC activities across multiple European markets.