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  • FDA approves GlaxoSmithKline's Votrient for soft tissue sarcomas

    PHILADELPHIA — The Food and Drug Administration has approved a drug made by GlaxoSmithKline for certain cancer patients.

  • FDA approves Novartis drug for tumors in patients with rare genetic disease

    EAST HANOVER, N.J. — A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

    The FDA approved Afinitor (everolimus) tablets for treating the tumors, known as renal angiomyolipomas, in adults with TSC who don't require surgery. The drug already was approved to treat brain tumors known as subependymal giant cell astrocytoma, or SEGA, in patients with TSC.

  • Vaccines in development could open opportunity for specialty pharmacies

    WHAT IT MEANS AND WHY IT'S IMPORTANT — Since the development of the first smallpox vaccine in 1796, vaccines have saved countless lives around the world and helped to make such deadly scourges as smallpox and polio things of the past.

    (THE NEWS: PhRMA report lists almost 300 vaccines under development. For the full story, click here.)

  • PhRMA report lists almost 300 vaccines under development

    WASHINGTON — Drug makers in the United States are developing nearly 300 vaccines for preventing and treating diseases, according to a new report by a drug industry trade group.

  • FDA declines to approve Takeda diabetes drug

    DEERFIELD, Ill. — The Food and Drug Administration declined to approve a drug made by Takeda Pharmaceutical, the drug maker said.

    Takeda announced that the FDA issued a complete response letter for its regulatory applications for the Type 2 diabetes drug alogliptin and a combination pill that includes alogliptin and pioglitazone, the active ingredient in the drug Actos.

  • Amgen to buy Turkish drug maker for $700 million

    THOUSAND OAKS, Calif. — Biotech drug maker Amgen is buying a pharmaceutical company based in Turkey, the companies said Wednesday.

    Amgen said it would acquire 95.6% of Istanbul-based Mustafa Nevzat for $700 million in an all-cash deal, saying the purchase would allow it to expand in Turkey and the surrounding region. The company, also known as MN, is a major supplier of injectable drugs in Turkey and, increasingly, an exporter of medicines.

  • Reports: GSK calls $2.6 billion offer for Human Genome Sciences 'full and fair'

    NEW YORK — GlaxoSmithKline said its offer to buy Human Genome Sciences was "full and fair" Wednesday after HGS turned it down last week, according to published reports.

    Reuters reported that GSK's $13-per-share, $2.6 billion offer for HGS would give the former full control of Benlysta (belimumab), the first new drug approved by the Food and Drug Administration for lupus in more than half a century. The two companies developed the drug together under a partnership, and the drug received approval in March 2011.

  • FDA outlines global food, drug, device safety strategy

    SILVER SPRING, Md. — Globalization has led to a rapid increase in the drugs and foods arriving on U.S. shores from abroad, a trend that has prompted U.S. regulators to transform their approach.

    The Food and Drug Administration released a report Monday detailing its strategies for what it called transforming from a domestic to a global public health agency.

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