Industry 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.

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.

Sun Pharmaceutical Industries Ltd announced that its wholly owned subsidiaries have reached an agreement with Ironwood Pharmaceuticals, Inc. and Allergan plc  to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Linzess® (Linaclotide capsules) in the US.

The Janssen Pharmaceutical Companies of Johnson & Johnson announced findings from the U.S. Food and Drug Administration’s (FDA) Mini-Sentinel assessment, confirming the positive safety and efficacy profile of XARELTO® (rivaroxaban) established in the phase III ROCKET AF clinical trials, were published in Pharmacoepidemiology & Drug Safety. Building on the mounting real-world evidence studied in more than 200,000 people, these findings are consistent with conclusions from other analyses and again confirm XARELTO®’s safety and effectiveness across a wide range of patients. The FDA Mini-Sentinel report also notes a lower risk of ischemic stroke was associated with the use of XARELTO® compared to warfarin and lasted throughout the more than three-year analysis.

Novartis announced results from the head-to-head CLARITY study demonstrating the superiority of Cosentyx® (secukinumab) compared to Stelara®* (ustekinumab) in delivering clear and almost clear skin in adults with moderate-to-severe plaque psoriasis at 12 weeks. The study results show 66.5% and 72.3% of patients treated with Cosentyx (p < 0.0001) achieved both co-primary endpoints PASI 90 and IGA mod 2011 0/1, respectively, compared to 47.9% and 55.4% patients, respectively, treated with Stelara®* (p < 0.0001). At Week 12, patients receiving Cosentyx had significantly greater PASI 100 responses (key secondary objective) compared to those taking Stelara®* (38.1% vs. 20.1%, respectively; p < 0.0001). The study findings, which support previously presented data from the CLEAR study demonstrating the superiority of Cosentyx to Stelara®* in achieving sustained skin clearance (PASI 90 response rates) at 52 weeks, were presented as an abstract today at the Winter Clinical Dermatology Conference in Hawaii.