Pharma News

The Janssen Pharmaceutical Companies of Johnson & Johnson announced  that the U.S. Food and Drug Administration (FDA) has approved ERLEADA™ (apalutamide), a next-generation androgen receptor inhibitor, for the treatment of patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). ERLEADA™ is the first FDA-approved treatment for these patients. Today’s approval follows an FDA Priority Review designation based upon data from the Phase 3 SPARTAN study, which demonstrated a 72 percent reduction in risk of distant metastasis or death, and an increase in median metastasis-free survival (MFS) by more than two years (difference of 24.31 months) in patients with NM-CRPC.

Researchers at the Children's Medical Center Research Institute (CRI) at UT Southwestern have discovered that cells in the liver with whole genome duplications, known as polyploid cells, can protect the liver against cancer. The study, published online today in Developmental Cell, addresses a long-standing mystery in liver biology and could stimulate new ideas to prevent cancer.

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Jubilant Life Sciences Ltd has received Abbreviated New Drug Application (ANDA) final approval for Amantadine Hydrochloride Tablets, 100 mg, the generic version of Symmetrel® of Endo, which is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus. It is also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions.

There has been a 66% decline in the estimated number of annual new HIV infections in the country from 2000 to 2015, against the global average of 35%.

As per National Health Accounts Estimates for India 2014-15, the total health expenditure per capita is estimated to be Rs. 3826.

Dr. Reddy’s Laboratories Ltd announced that it has launched Tetrabenazine Tablets, a therapeutic equivalent generic version of Xenazine® (tetrabenazine) in the United States market approved by the U.S. Food and Drug Administration (USFDA).

Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TAK-426, Takeda’s purified, inactivated, alum-adjuvanted, whole Zika virus vaccine candidate.

In a significant development for Indian patients requiring treatment for structural or congenital heart disease and defects, Admedus Limited  in partnership with Syncronei Medical India Pvt Ltd, and supported by the Australian Trade and Investment Commission (Austrade), is pleased to introduce its ground-breaking and clinically-superior ADAPT® technology in India.