Industry News

The US Food and Drug Administration (FDA) has cleared Turing Pharmaceuticals AG's Investigational New Drug (IND) application for TUR-004 in the treatment of epileptic encephalopathies. In addition, TUR-004 has been granted Fast Track designation.

Resverlogix Corp. announced the commencement of a phase 3 clinical trial called 'BETonMACE' with lead drug apabetalone (RVX-208) in high-risk patients with coronary artery disease (CAD) and type 2 diabetes mellitus (DM).  Resverlogix has received initial approval from the regulatory authority and ethics committee in the first three countries: Belgium, Hungary and Israel, which will represent approximately 15 investigative sites of an expected 175 site trial. The first site initiation visit was held yesterday and with drug now available to the centers, enrollment of patients will commence. Over the course of the coming months, additional investigative sites will be activated.

GSK announced that stepwise trial design of its losmapimod phase III study, LATITUDE-TIMI 60, an interim review of data from part A of the study (an initial cohort of 3,503 patients) did not indicate efficacy against the primary endpoint and did not support investment in the larger part B of the study as currently designed.

Lupin Pharmaceuticals Inc, a subsidiary of the company, has launched calcium acetate capsules having received final approval from the US health regulator. The drug is indicated for the control of hyperphosphatemia in end stage renal failure.

Endo Pharmaceuticals Inc., a subsidiary of Endo International plc, and BioDelivery Sciences International, Inc. (BDSI), a specialty pharmaceutical company, announced that the US Food and Drug Administration (FDA) has approved Belbuca (buprenorphine) buccal film for use in patients with chronic pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Sinovac Biotech Ltd., a leading provider of biopharmaceutical products in China, announced that one of its subsidiaries, Sinovac Dalian, has received approval to begin human clinical trials on its varicella vaccine candidate. The clinical trial application for the varicella vaccine was officially accepted by the China Food and Drug Administration (CFDA) in January 2013.

[adsense:336x280:8701650588]

Glenmark Pharmaceuticals has entered into an agreement with Poland based Celon Pharma to develop and market a generic version of GlaxoSmithKline's Seretide Accuhaler in Europe used for treatment of lung diseases. The fluticasone/salmeterol dry powder inhaler is a combination product for the treatment of chronic obstructive pulmonary disease.

Indian Immunologicals Limited (IIL), a leading biologicals company, has set up a new facility with an investment of Rs.250 crore near here and is set to become India's largest producer of animal health formulations.

One stop diagnostics and patient management system "Healthcube Pro" capable of executing 32 tests at the same time was the showstopper at the fourth edition of Indian Pharma Expo 2015 which opened on Saturday.

The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Novartis' Cosentyx (secukinumab) in Europe to treat ankylosing spondylitis (AS) and psoriatic arthritis (PsA) patients. Cosentyx is the first of a new class of medicines called interleukin-17A (IL-17A) inhibitors to be recommended for AS and PsA - conditions that affect around five million people in Europe.