Industry News

Biota Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its antiviral compound, BTA585, for the treatment of respiratory syncytial virus (RSV) infections in infants, young children and adults.

As a safety measure against the emerging Zika virus outbreak, today the U.S. Food and Drug Administration issued a new guidance recommending the deferral of individuals from donating blood if they have been to areas with active Zika virus transmission, potentially have been exposed to the virus, or have had a confirmed Zika virus infection.

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Remedy Pharmaceuticals, a privately-held, Phase 3-ready pharmaceutical company focused on bringing life saving hospital-based treatment to people affected by central nervous system (CNS) related edema, announced that the United States Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead drug, CIRARA™, for both the treatment of acute subarachnoid hemorrhage and acute spinal cord injury.

Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved additional indications for Harvoni® (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease.

Amgen announced that the randomized, double-blind, placebo-controlled Phase 3 Aranesp® (darbepoetin alfa) ARCADE trial met its primary endpoint of reducing the incidence of red blood cell transfusions in anemic patients with low and intermediate-1 risk Myelodysplastic Syndrome (MDS) at the end of the blinded 25-week study period. Aranesp also significantly improved erythroid response, a key measure of the formation of new red blood cells. Detailed results will be submitted to a future medical conference and for publication.

Kindred Biosciences seeks US FDA approval for Zimeta to treat pyrexia in horseKindred Biosciences, Inc., announced the submission to FDA of the Effectiveness Technical Section of the New Animal Drug Application (NADA) for Zimeta™ (dipyrone injection, KIND-012).

Merck, known as MSD outside the United States and Canada, announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter regarding Merck's Supplemental New Drug Applications for ZETIA® and VYTORIN® for the reduction of the risk of cardiovascular events (cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, hospitalization for unstable angina, or need for revascularization) in patients with coronary heart disease.

Wenzel Spine, Inc., a pioneer medical device company focused on providing minimally invasive, stand-alone alternatives to traditional spinal fusion, announced today that it received clearance from the U.S. Food and Drug Administration (FDA) to market VariLift®-LX as an interbody fusion device for stand-alone use in the lumbar spine.

Biocon Ltd., announced that it has received European approvals for its Rosuvastatin Calcium 5 mg, 10 mg, 20 mg and 40 mg tablets, a generic equivalent of Crestor® tablets, indicated for hyperlipidemia or mixed dyslipidemia.