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Specialty Pharmacy

  • FDA approves Vyxeos for acute myeloid leukemia
    SILVER SPRING, Md. — A new treatment for certain types of acute myeloid leukemia has been cleared by the Food and Drug Administration. Jazz Pharmaceuticals’ Vyxeos was approved for newly diagnosed therapy-related AML or AML with myelodysplasia-related changes
     

  • FDA approves Imbruvica expansion to treat chronic graft versus host disease

    SILVER SPRING, Md. — Janssen Biotech and Pharmacyclics’ Imbruvica (ibrutinib) has a new indication. The Food and Drug Administration on Wednesday approved the drug to treat adults with chronic graft versus host disease after one or more treatments have failed.

    This approval makes Imbruvica the first FDA-approved treatment for the illness, which afflicts patients who have received hematopoietic stem cell transplantation to treat blood or bone marrow cancers. The illness occurs when cells from the stem cell transplant attack healthy cells in a patient’s tissues.

  • AmerisourceBergen’s pharmaceutical distribution segment drives Q3 revenue increase

    VALLEY FORGE, Pa. — AmerisourceBergen on Thursday reported its third quarter results, posting a 4.9% increase in revenue, which hit $38.7 billion. The company’s gross profit declined 2.5% to $1.1 billion, which it attributed to a $121 million decrease in gains from antitrust litigation settlements and a decrease in the pharmaceutical distribution services segment.

  • Diplomat named distributor of newly approved Nityr

    FLINT, Mich. — Diplomat Pharmacy will be exclusively dispensing Cycle Pharmaceuticals’ Nityr (nitisinone) tablets, the company announced Thursday. The Food and Drug Administration approved Nityr on Aug. 1 to treat the rare disease hereditary tyrosinemia Type 1, or HT-1, in combination with dietary restriction of tyrosine and phenylalanine.

  • FDA clears hepatitis C drug Mavyret

    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug to treat adults with chronic hepatitis C virus genotypes 1-6. Mavyret, from AbbVie, was approved for HCV patients without cirrhosis or with mild cirrhosis, including patients with moderate to severe kidney disease and those on dialysis.

    The FDA said that Mavyret is the first treatment of eight-week duration for all hepatitis C genotypes.

  • FDA Reauthorization Act heads to Trump’s desk after Senate passage

    WASHINGTON — The Senate on Thursday voted to pass the Food and Drug Administration Reauthorization Act of 2017, sending the bill to the desk of President Donald Trump following the House’s passage of the legislation in June. The bill contains the reauthorizations of the FDA’s Prescription Drug, Biosimilar, and Generic Drug User Fee Acts.

  • Walgreens Boots Alliance partners with KKR on PharMerica acquisition, settles with Theranos

    DEERFIELD, Ill. — Walgreens Boots Alliance has had a busy week.

    As a minority investor, the company on Wednesday announced that it had formed a new company with KKR, through which the two acquired institutional pharmacy company PharMerica. The all-cash transaction is valued at roughly $1.4 billion and will make PharMerica a private company.

  • FDA approves new indication for Kalydeco

    SILVER SPRING, Md. — The Food and Drug Administration on Tuesday approved a new indication for Vertex Pharmaceuticals’ Kalydeco (ivacaftor). The new indication is for use in more than 600 people with cystic fibrosis ages 2 years and older who have one of five residual function mutations.

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