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  • FDA approves Janssen’s Stelara to treat Crohn’s disease

    SILVER SPRING, Md. — Janssen Biotech announced Monday that the Food and Drug Administration had approved its Stelara (ustekinumab) to treat moderately to severely active Crohn’s disease.  
     
    It is now indicated for adults with Crohn’s disease who have failed or were intolerant to corticosteroid or immunomodulator treatments, but never failed treatment with a tumor necrosis factor (TNF) blocker, or who failed or were intolerant of one or more TNF blocker treatment. 
     
  • Endo names Campanelli president, CEO

    DUBLIN — Endo has a new president and CEO. The company announced Tuesday that its board of directors had named Paul Campanelli to the position, effective immediately, succeeding Ravid De Silva, who has stepped down from the position and his place on the company's board of directors.
     
  • Allergan, Adamas announce new Namzaric dosage strengths availability

    DUBLIN and EMERYVILLE, Calif. —Allergan and Adamas Pharmaceuticals on Thursday announced the availability of all four dosage strengths of its Namzaric (memantine and donepezil hydrochloride) extended-release capsules. 
     
    Namzaric is a fixed-dose combination of memantine and 10 mg donepezil hydrochloride indicated to treat moderate to severe Alzheimer’s disease in patients stabilized on 10 mg of donepezil hydrochloride. The Food and Drug Administration approved the drug in July. 
     
  • FDA approves Janssen’s Invokamet XR

    SILVER SPRING, Md. — The Food and Drug Administration has approved Janssen Pharmaceuticals’ Invokamet XR, a once-daily, extended-release combination therapy of Invokana (canagliflozin) and metformin, the company announced Wednesday. The drug is indicated as a first-line treatment to improve blood glucose control in adults with Type 2 diabetes alongside diet and exercise. 
     
  • PhRMA brings scientists to Capitol Hill

    WASHINGTON — The Pharmaceutical Research and Manufacturers of America (PhRMA) on Wednesday brought 60 of its member companies’ researchers to Capitol Hill for meetings with members of Congress. The researchers will discuss with lawmakers how they can support developing new, innovative medicines. 
     
  • FDA approves low-dose appetite suppressant Lomaira

    SILVER SPRING, Md. — The Food and Drug Administration has approved KVK Tech’s Lomaira (phentermine HCl), the company announced Tuesday. The drug is indicated for short-term use to aid in weight reduction in obese and overweight patients (patients with body mass indices of 30 or higher and 27 or higher, respectively) with at least one weight-related condition, including high blood pressure and diabetes. 
     
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