Industry News

U.S. Customs and Border Protection (CBP) announced a new formal partnership arrangement with Procter & Gamble (P&G), as part of the Donations Acceptance Program, to prevent counterfeit P&G products from entering the United States. As part of the partnership, P&G will donate testing devices to verify the authenticity of various P&G products.

Celgene Corporation announced that data from the phase III RELIEF™ clinical trial of OTEZLA® (apremilast) in patients with active Behçet’s Disease with oral ulcers were presented in a late-breaking oral presentation at the 2018 American Academy of Dermatology (AAD) Annual Meeting. The results showed statistically significant reductions in oral ulcers with apremilast 30 mg twice daily (BID) versus placebo through week 12. OTEZLA (apremilast) is Celgene’s oral selective inhibitor of phosphodiesterase 4 (PDE4).

Sumitomo Dainippon Pharma Co., Ltd filed patent infringement lawsuits jointly with its U.S. subsidiary, Sunovion Pharmaceuticals Inc. (“Sunovion”) on February 13, 2018 (U.S. Eastern Time) in the U.S. District Court for the District of New Jersey against Emcure Pharmaceuticals Ltd. and in the U.S. District Court for the District of Delaware against Amneal Pharmaceuticals LLC regarding their submissions of Abbreviated New Drug Applications (“ANDAs”) for generic copies of LATUDA® (lurasidone HCl tablets). The lawsuits allege infringement of Sumitomo Dainippon Pharma’s U.S. Patent No. 9,815,827 (“the ’827 Patent”). These lawsuits are separate and different from the pending lawsuits, filed on January 14, 2015 in relation to Sumitomo Dainippon Pharma’s U.S. Patent No. 5,532,372.

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.

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.

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).

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.

Bharat Biotech announced that the World Health Organization (WHO Geneva) has awarded prequalification to the developing world’s first rotavirus vaccine, ROTAVAC®.

Eli Lilly and Company announced that the European Commission has granted marketing authorisation (MA) for Taltz® (ixekizumab), alone or in combination with methotrexate, for the treatment of active psoriatic arthritis (PsA) in adult patients who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drug (DMARD) therapies.

Biocon Ltd Asia's premier biopharmaceuticals company, and Sandoz, a Novartis division and a global leader in biosimilars, announced a global partnership to develop, manufacture and commercialize multiple biosimiiars in immunology and oncology for patients worldwide.