Orion has recruited the first patients in the Phase III clinical trial (REFALS) in which orally administered levosimendan (ODM-109) is being evaluated for the treatment of symptoms of amyotrophic lateral sclerosis (ALS). The purpose of the trial is to demonstrate that orally administered levosimendan, by enhancing respiratory muscle function, can help maintain breathing capacity and so benefit the overall functioning of patients with ALS....
PIPE LINE REVIEW
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The federal government’s probe into pharma’s co-pay assistance charities has snared some of the biggest names in the business, and Thursday the Department of Justice said three drugmakers have inked settlements totaling $122.6 million. Jazz, Lundbeck and Alexion each struck deals with the DOJ—worth $57 million, $52.6 million and $13 million, respectively—to resolve allegations of using payments to charities as “conduits” to help Medicare and other patients aff...
FIERCEPHARMA
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Merck & Co has begun a rolling filing in the US of its Ebola Zaire vaccine, known as V920 after the FDA said it could represent a breakthrough in treatment. Known as MSD outside the US, Merck & Co said it will file information bit-by-bit about V920 (rVSV∆G-ZEBOV-GP, live attenuated) and expects all the data to be with the regulator next year. The FDA gave V920 Breakthrough Therapy Designation in July 2016, which is intended to hasten development and review of drugs that treat serious or ...
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Seasonal influenza vaccines are typically less than 50 percent effective, according to Centers for Disease Control and Prevention studies. Research at the University of Alabama at Birmingham, published this week in Nature Immunology, may point a path to more effective vaccines. Researchers led by Troy Randall, Ph.D., professor in the UAB Department of Medicine’s Division of Clinical Immunology and Rheumatology, studied a type of immune cell in the lung called a resident memory B cell. Up t...
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Alexion has made no secret of its plan to diversify beyond its blockbuster rare disease franchise. Now, the company has taken a flier out on a disappointing drug that targets severe bleeding—and it's hoping to parlay its hospital contacts into a sales boost that'll appease unruly investors. Alexion agreed to buy Portola Pharmaceuticals and its sole approved medicine, anticoagulant reversal agent Andexxa, in a deal valued at around $1.4 billion, the drugmakers said Monday. That'...
FIERCEPHARMA
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In a study published in Epilepsia, young people taking anti-epileptic drugs experienced elevated rates of bone fractures and had reductions in tibial bone mineral density and lower limb muscle force....
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