Industry News

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.

Aurobindo Pharma Limited has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market  Tramadol Hydrochloride Extended -release Tablets USP, 100 mg, 200 mg and 300 mg.

AstraZeneca and Eli Lilly deepening their collaboration in cancer immunotherapy by testing new drug combinations for treating solid tumours.

The anti-malarial compound Artemisinin, the discovery of which won Tu Youyou China's first Nobel Prize for Physiology or Medicine this year, has not resulted in big profits for Chinese pharmaceutical companies.

Jubilant Life Sciences Ltd, an integrated global Pharmaceuticals and Life Sciences Company, has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg and 10 mg, the generic version of Maxalt-MLT Orally Disintegrating, 5 mg and 10 mg.

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Novartis acquire Admune, a clinical-stage biotech company focused on the development and delivery of cytokine therapy drugs for cancer, for the company’s IL-15 agonist program, currently in Phase I clinical trials for metastatic cancer. The fee is not being disclosed. Novartis also signed a $15 million licensing agreement with Palobiofarma. The company, based at Barcelona’s science park, focuses on the discovery and development of new drugs based on the modulation of adenosine receptors.

DelMar Pharmaceuticals, a biopharmaceutical company focused on the development and commercialization of new cancer therapies, announced that it presented positive preclinical data demonstrating the promising potential of its lead product candidate VAL-083 (dianhydrogalactitol) as a treatment for ovarian cancer.

Edwards Lifesciences Corporation, a global leader in the science of heart valves and hemodynamic monitoring, has received US Food and Drug Administration (FDA) approval for aortic valve-in-valve procedures using the Edwards Sapien XT transcatheter heart valve.