Pharma News

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.

Much of the research on Alzheimer's disease has focused on the amyloid beta protein, which clumps together into sticky fibrils that form deposits in the brains of people with the disease. In recent years, attention has turned away from the fibrils themselves to an intermediate stage in the aggregation of amyloid beta. "Oligomers" consisting of a few molecules of the protein stuck together are more mobile than the large, insoluble fibrils and seem to be much more toxic. But the actual structure of these soluble oligomers remains unknown, and it's unclear how they trigger the neurotoxic effects that lead to Alzheimer's disease.

Nektar Therapeutics (NASDAQ: NKTR) today announced new preclinical data for NKTR-214, an immuno-stimulatory CD-122 biased cytokine currently being evaluated in cancer patients with solid tumors in a Phase 1/2 clinical trial being conducted at MD Anderson Cancer Center and Yale Cancer Center. The new preclinical data presented demonstrate that treatment with single-agent NKTR-214 mobilizes tumor-killing T cells into colon cancer tumors.  In addition, mouse pharmacodynamics data demonstrated that a single dose of NKTR-214 can increase and sustain STAT5 phosphorylation (a marker of IL-2 pathway activation) through one week post-dose. These data were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL from June 3-7, 2016.

Amgen announced new data from a prespecified interim analysis of the phase 3 TOWER study, in which Blincyto (blinatumomab) demonstrated an almost two-fold increase in median overall survival (OS) compared to standard of care (SOC). The randomized, open-label TOWER study evaluated the efficacy of Blincyto versus SOC chemotherapy in adult patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).