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  • FDA approves Genentech’s bladder cancer drug

    WASHINGTON — The Food and Drug Administration granted accelerated approval to Genentech’s Tecentriq (atezolizumab) for the treatment of people with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin chemotherapy. Tecentriq was previously approved for people with locally advanced or mUC who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of receiving chemotherapy before surgery (neoadjuvant) or after surgery (adjuvant).

  • J&J’s Actelion acquisition expected to close this quarter

    NEW BRUNSWICK, N.J. — Johnson & Johnson confirmed Tuesday during its 2017 fiscal first-quarter earnings report that it expects its $30 billion acquisition of Actelion to close this quarter.

    “The public tender offer for Actelion has been declared successful based on the number of shares tendered and regulatory approval has been obtained in six of seven jurisdictions in which the company filed for such approval, with antitrust approval from the European Commission pending.”

  • Missouri final state to pass prescription drug pricing database legislation

    JEFFERSON CITY, Mo. — Missouri’s State Senate passed legislation to make it the final state to adopt a prescription drug pricing database. The bill would create a database pharmacists and doctors could check to see if patients have recently filled or been prescribed addictive medications.

  • Neurocrine Biosciences’ Ingrezza is first FDA-approved drug for tardive dyskinesia

    WASHINGTON — The Food and Drug Administration approved Neurocrine Biosciences’ Ingrezza (valbenazine) capsules to treat adults with tardive dyskinesia. This is the first drug approved by the FDA for this condition.  

    Tardive dyskinesia is a neurological disorder characterized by repetitive involuntary movements, usually of the jaw, lips and tongue, such as grimacing, sticking out the tongue and smacking the lips. Some affected people also experience involuntary movement of the extremities or difficulty breathing.

  • Akorn confirms discussions to be potentially acquired

    LAKE FOREST, Ill. — Specialty generic pharmaceutical company Akorn confirmed it is in talks to be possibly be acquired by Fresenius Kabi, a subsidiary of Fresenius SE & Co. KGaA.

  • Reports: Teva weighing sale of women’s health unit

    JERUSALEM — Teva Pharmaceuticals is considering a sale of its women’s health unit, which could earn the company $2 billion in proceeds, according to multiple news reports.

    Teva is reportedly working with Morgan Stanley to find a buyer and could begin the process as early as May, reported Israeli newspaper Globes.

    Teva acquired the women’s health division from Merck KGaA’s Merck Serono in 2010.

  • Biohaven Pharmaceutical files for IPO

    NEW HAVEN, Conn. — Biohaven Pharmaceutical filed a Form S-1 with the Securities and Exchange Commission, hoping to obtain up to $100 million in proceeds from its initial public offering. The company plans to list its shares under the ticker symbol BHVN on the New York Stock Exchange.

  • FDA approves Gilead’s hepatitis C drugs for teenagers

    WASHINGTON — The Food and Drug Administration today approved supplemental applications for Gilead Sciences’ Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus in children ages 12 to 17.

    According to the FDA, these are the first direct-acting antiviral treatments approved for children and adolescents with HCV. Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from multiplying, and in most cases, they cure HCV.

    Harvoni and Sovaldi were previously approved to treat HCV in adults.

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