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.
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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.
U.S. Food and Drug Administration approved Yondelis (trabectedin), a chemotherapy, for the treatment of specific soft tissue sarcomas (STS) – liposarcoma and leiomyosarcoma – that cannot be removed by surgery (unresectable) or is advanced (metastatic). This treatment is approved for patients who previously received chemotherapy that contained anthracycline.
Ambry Genetics (Ambry), a leader in clinical genetic diagnostics and genetics software solutions, announced that it is launching a new suite of seven genetic testing panels for epilepsy.
Tests can be ordered from November 6 with the first samples expected to be tested on November 9.
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