Industry News

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.

In consultation with the U.S. Food and Drug Administration (FDA), the U.S. Product Inserts (USPI) for VIEKIRA PAK® (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and TECHNIVIE™ (ombitasvir, paritaprevir, and ritonavir tablets) have been updated from 'not recommended in Child Pugh B patients' to a contraindication in patients with Child-Pugh B cirrhosis. The updated USPI for VIEKIRA PAK also includes a recommendation for physicians to assess evidence of hepatic decompensation prior to treatment and during treatment in cirrhotic patients.

Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved Strensiq (asfotase alfa) for the treatment of patients with perinatal-, infantile- and juvenile-onset hypophosphatasia (HPP).

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Allergan plc, a leading global pharmaceutical company, announced the launch of the over-the-counter artificial tear Refresh Optive gel drops, a new aqueous gel expertly designed for patients to relieve their dry eye symptoms. New Refresh Optive Gel Drops are formulated with Glycerin and a unique blend of the active ingredient CMC which binds to the eye surface to provide long-lasting relief from dry eye discomfort.