Pharma News

Fungal infections can be devastating to human health, killing approximately 150 people every hour, resulting in over a million deaths every year, more than malaria and tuberculosis combined.

Abbott, a global healthcare company, announced the results of the IMPACT clinical trial, which demonstrated that the FreeStyle Libre system met its primary endpoint of a reduction in time spent in hypoglycemia (low glucose levels, defined as <70 mg/dL1) for people with type 1 diabetes. People in the trial who used Abbott's FreeStyle Libre sensor and reader system spent 38 percent less time in hypoglycemia, as compared to people who managed their glucose with traditional self-monitoring of blood glucose (SMBG) systems (pricking a finger to draw a drop of blood that is added to a test strip inserted into a glucose meter). Data were presented at the American Diabetes Association's 76th Scientific Sessions.

Ajanta Pharma Limited, announced the launch of memantine hydrochloride tablets in the US market through its wholly owned subsidiary Ajanta Pharma USA Inc. Memantine hydrochloride is an anti-dementia drug and is a bioequivalent generic version of Namenda.

Shire plc, a leading global biotechnology company, has agreed to license global rights to all indications for PF-00547659 from Pfizer Inc.  PF-00547659 is an investigational biologic being evaluated for the treatment of moderate-to-severe inflammatory bowel disease (IBD). PF-00547659 has been evaluated in more than 700 patients in phase 1 and 2 trials, and phase 3 trials are expected to begin after consultation with global health authorities. Closing of the transaction is subject to HSR approval. Terms of the deal were not disclosed.

Amgen announced that the Arthritis Advisory Committee of the US Food and Drug Administration (FDA) will review data supporting the company's Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).

Amedica Corporation announced that it has submitted its responses to the Food and Drug Administration (FDA) in relation to the CASCADE clinical trial.The CASCADE study compared the 24-month outcomes from single-level cervical fusion between Amedica's porous silicon nitride versus bone autograft. Data showed that porous silicon nitride achieved clinical and radiographic outcomes that were comparable to bone autograft.

Pfizer Inc. announced the publication of findings from the phase 3 INO-VATE ALL study in the online issue of The New England Journal of Medicine. The study, also known as Study 1022, is an open-label, randomized, phase 3 study evaluating the safety and efficacy of inotuzumab ozogamicin as compared with investigator-choice chemotherapy in 326 adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL).

Shire plc, a leading global biotechnology company, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for two investigational products for rare diseases: SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE), and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2 (PFIC2).

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ProMetic Life Sciences Inc. reported  that the U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to ProMetic for its plasminogen drug candidate, currently in a phase 2/3 clinical trial in patients suffering from congenital Plasminogen deficiency.

Since the 1980s, continuous positive airway pressure (CPAP) - in which positive pressure is pushed through the nasal airways to help users breathe while sleeping - has been by far the most widely used treatment for obstructive sleep apnea (OSA). With more than 18 million people experiencing OSA, a number expected to rise, new results from a Penn case study of a new device implanted in the chest called hypoglossal nerve stimulation (HGNS) offers promise for patients with moderate to severe OSA who cannot tolerate CPAP. Researchers at the Perelman School of Medicine at the University of Pennsylvania will present data (abstract 0378) on their outcomes with hypoglossal nerve stimulation for the treatment of patients with sleep apnea at SLEEP 2016, the 30th annual meeting of the Associated Professional Sleep Societies LLC.