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FDA Approves BREO ELLIPTA for the Treatment of Adults With Asthma in the US

LONDON, UNITED KINGDOM and SOUTH SAN FRANCISCO, CA–(Marketwired – Apr 30, 2015) – GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved BREO® ELLIPTA® (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older. Breo Ellipta is […]

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FDA approves Glaxo, Theravance’s Breo Ellipta asthma drug

(Reuters) – The U.S. Food and Drug Administration on Thursday approved the sale of Breo Ellipta as a once-daily treatment for asthma in patients aged 18 and older, GlaxoSmithKline and Theravance Inc said.   The FDA declined to approve Breo for younger asthma sufferers. The agency, in a so-called complete response letter, told the companies […]

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FDA approves Medicines Co’s blood-clotting agent

(Reuters) – The U.S. Food and Drug Administration on Thursday approved The Medicines Co’s dry powder blood-clotting agent for use in hospital settings, a month after the treatment received approval in Europe. The treatment, Raplixa, is a combination of two human plasma-derived blood-clotting proteins – fibrinogen and thrombin. (1.usa.gov/1HVGQSd) Raplixa is used to control bleeding […]

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FDA approves BREO ELLIPTA for the treatment of adults with asthma in the US

LONDON and SAN FRANCISCO, April 30, 2015 /PRNewswire/ — GlaxoSmithKline plc (LSE: GSK) and Theravance, Inc. (NASDAQ: THRX) today announced that the US Food and Drug Administration (FDA) has approved BREO® ELLIPTA® (fluticasone furoate/vilanterol [FF/VI]) for the once-daily treatment of asthma in patients aged 18 years and older. Breo Ellipta is not indicated for the […]

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Eisai and Glenmark Reach Settlement over Generic Version of BANZEL (rufinamide)

WOODCLIFF LAKE, N.J., April 30, 2015 /PRNewswire/ — Eisai Inc. and Eisai Co., Ltd. have entered into a settlement agreement with Glenmark Pharmaceuticals, Ltd., Glenmark Generics Ltd., and Glenmark Generics, Inc., USA (“Glenmark”), to resolve their patent litigation relating to Eisai’s BANZEL® (rufinamide) in the United States. As a result of the settlement, Glenmark will be […]

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Celgene sales highlight Revlimid dependence ahead of patent ruling

(Reuters) – Celgene Corp’s dependence on its big-selling multiple myeloma drug Revlimid raised investor concerns on Thursday as sales of its other medicines fell short of expectations. Celgene shares fell 5 percent after the company reported quarterly results in which Revlimid shored up profits. Industry analysts see room for Revlimid to grow much further, with […]

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Nexium, Advair led Medicare drug spending in 2013 – officials

(Reuters) – Four brand-name medications accounted for almost one-tenth of the $103 billion in prescriptions filled by older or disabled Americans under Medicare’s drug program in 2013, U.S. officials reported on Thursday. The Centers for Medicare and Medicaid Services (CMS) said AstraZeneca Plc’s Nexium “purple pill” for acid reflux topped the list with prescriptions totaling […]

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IMS Health Finds Wide Disparity Between Essential Medicines List of WHO and Several Pharmerging Countries

DANBURY, Conn.–(BUSINESS WIRE)–The high level of disparity between the World Health Organization’s Model Essential Medicines List (EML) and the EMLs of nine pharmerging countries was highlighted in remarks by Murray Aitken, executive director of the IMS Institute for Healthcare Informatics, at the WHO’s Expert Committee session on April 20. At the Geneva meeting, Aitken presented […]

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U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Patients with Previously Untreated Advanced Melanoma

PRINCETON, N.J.–(BUSINESS WIRE)–Bristol-Myers Squibb Company (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted Priority Review for this application. The projected FDA […]

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Breckenridge Announces Approval for Repaglinide Tablets, USP

BOCA RATON, Fla., April 29, 2015 /PRNewswire/ — Breckenridge Pharmaceutical, Inc. announces the final approval by the U.S. Food and Drug Administration of the Abbreviated New Drug Application for Repaglinide Tablets USP, which is being manufactured and supplied by Standard Chem. & Pharm. Co., Ltd. Taiwan, and will be available in 0.5mg, 1mg, and 2mg strengths. […]

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