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  • Purdue Pharma submits NDA for hydrocodone bitartrate tabs

    STAMFORD, Conn. — Purdue Pharma on Wednesday announced that it filed a new drug application with the Food and Drug Administration to market a hydrocodone bitartrate tablet.

    The pain medication was formulated to incorporate abuse-deterrent technology, making the drug more difficult to manipulate for the purpose of abuse, the company said. Data from clinical trials of the investigational medicine were presented at the 33rd Annual Scientific Meeting of the American Pain Society in Tampa, Fla.

  • FDA approves GSK's Incruse Ellipta

    LONDON — GlaxoSmithKline on Wednesday announced that the Food and Drug Administration approved Incruse Ellipta (umeclidinium), which is used for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease, or COPD, including chronic bronchitis and/or emphysema.

    Umeclidinium is the company's first once-daily anticholinergic, a type of bronchodilator also known as a long-acting muscarinic antagonis and is contained in the Ellipta inhaler. The FDA-approved strength is 62.5-mcg.

  • FDA grants accelerated approval to Zykadia

    SILVER SPRING, Md. — The Food and Drug Administration on Tuesday granted approval to Zykadia (ceritinib) for patients with a specific type of late-stage (metastatic) non-small cell lung cancer (NSCLC).

    The drug — an anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor — blocks proteins that promote the development of cancerous cells and is intended for patients with metastatic ALK-positive NSCLC who were previously treated with crizotinib.

  • Anoro Ellipta now available in retail pharmacies

    LONDON — GlaxoSmithKline and Theravance on Monday announced that Anoro Ellipta (umeclidinium and vilanterol inhalation powder), a once-daily that combines two long-acting bronchodilators in a single inhaler, is now available in retail pharmacies in the United States.

    Anoro Ellipta is used for long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. It is not indicated for the relief of acute bronchospasm or the treatment of asthma. The FDA-approved strength is umeclidinium/vilanterol 62.5/25-mcg.

  • IMS: Rx spending increases in 2013

    Total spending on U.S. medicines increased 1% on a real per capita basis in 2013, while the use of healthcare services rose for the first time in three years, according to a report by the IMS Institute for Healthcare Informatics.

  • Business program: Advancing the voice of health care

    SCOTTSDALE, Ariz. — Nuanced and intuitive leadership. That’s how Steve Anderson, president and CEO for the National Association of Chain Drug Stores, characterized today’s state of the NACDS — a body made greater by the sum of its parts that has successfully navigated the complexities of today’s evolving healthcare environment, as well as the intricacies of the political arena — on Sunday during his address before attendees of the NACDS Annual Meeting 2014.

  • Curating the life science data cloud

    As lifetime earnings for pharmaceuticals decrease, commercialization expenses increase and payers tighten their belts on reimbursement, life science companies will be faced with shrinking margins over the next few years.

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