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  • FDA expands Prezista indication
    SILVER SPRING, Md. — The Food and Drug Administration has approved a bew indication for Janssen Therapeutics’ Prezista (darunavir), the company announced Monday. Prezista, a treatment for HIV-1 in adults and children older than 3 years of age, can now be used by pregnant women with HIV. 
     

  • Industry orgs respond to PDUFA reauthorization letter
    SILVER SPRING, Md. and WASHINGTON — The Food and Drug Administration on Friday released a document containing details — procedures and performance goals — for the Prescription Drug User Fee Act (PDUFA) reauthorization, or PDUFA VI. 
     

  • Report: FDA panel backs Amgen’s Humira biosimilar

  • FDA approves Shire’s Xiidra
    SILVER SPRING, Md. — The Food and Drug Administration has approved Shire’s Xiidra (lifitegrast ophthalmic solution, 5%), the company announced Tuesday. Xiidra is twice-daily eyedrop solution indicated to treat signs and symptoms of dry eye, which affects an estimated 16 million adults in the U.S. The drug is the first approval from Shire’s ophthalmics pipeline
     

  • Protein Sciences: FDA approves 2016/17 formulation of Flublok

    MERIDEN, Conn. - Protein Sciences Corporation on Tuesday announced that FDA has approved the 2016/17 formulation of Flublok influenza vaccine.   

    FDA approval of the 2016/17 formulation of Flublok means that Flublok is on track to ship to healthcare providers in early August.     

  • Iroko names Louis Vollmer president, CEO
    PHILADELPHIA — Iroko Pharmaceuticals on Monday announced that it had named Louis Vollmer to the positions of president and CEO at the company, effective July 6. He has been president of the company since March 2015 and succeeds Iroko founder Osagie Imasogie as CEO. 
     
    Vollmer will oversee day-to-day operations and long-term planning for Iroko, with a focus on its SoluMatrix franchise brands. Osagie will stay on as chairman of Iroko’s board. 
     

  • FDA approves wearable delivery system for Amgen’s Repatha
    SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug delivery device for Amgen’s Repatha (evolocumab), the company announced Monday. The Pushtronex system is an on-body infusor with a pre-filled cartridge with a 420-mg monthly dose of the cholesterol-lowering drug, one of two new drugs in a class of PCSK9 inhibitors. 
     

  • Health Canada allows immediate access to Narcan nasal spray
    OTTAWA — Canada’s minister of health on Wednesday signed an interim order that will bring immediate access to Narcan (naloxone) nasal spray. The order allows the nasal spray, made by Adapt Pharma, to be imported from the U.S. and sold in Canda, where only the injectable version of the opioid overdose reversal drug had been available. 
     
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