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BioCentury Extra
As published Friday, August 22, 2014 4:27 PM PST


  • EMA to review Cubist's ceftolozane/tazobactam

    EMA accepted for review an MAA for ceftolozane/tazobactam from Cubist Pharmaceuticals Inc. (NASDAQ:CBST) to treat complicated urinary tract infections (cUTIs) and complicated intra-abdominal infections (cIAIs). A decision is expected in 2H15.

    In June, FDA granted Priority Review to Cubist's NDA for the IV combination therapy, which comprises the cephalosporin antibiotic ceftolozane (CXA-101) and the beta lactamase inhibitor tazobactam. The PDUFA date is Dec. 21.

    Cubist plans to start Phase III testing of ceftolozane/tazobactam to treat hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP) this year.

    Cubist has worldwide rights to ceftolozane from Astellas Pharma Inc. (Tokyo:4503). Cubist was up $1.14 to $66.06 on Friday.

  • WaferGen raises $20M, moves to NASDAQ

    WaferGen Bio-systems Inc. (NASDAQ:WGBS) raised $20 million in a follow-on and moved its listing to NASDAQ from the over-the-counter market. Ladenburg Thalmann; National Securities; and Brean Capital were underwriters. The maker of sequencing equipment sold 2,000 units at $10,000 in the offering. Each unit comprises 2,000 shares and 2,000 five-year warrants exercisable at $5. Shares fell $5.05 (51%) to $4.95 on Friday.

  • Bao Hao buying stake in 20/20 GeneSystems

    A U.S. affiliate of China's Bao Hao Investment Management Co. Ltd. will pay an undisclosed amount to acquire an equity stake in diagnostics company 20/20 GeneSystems Inc. (Rockville, Md.). 20/20 GeneSystems markets PAULA's blood test in the U.S. for the early detection of lung cancer. Bao Hao is "seeking to help advance the introduction in China" of the test, which scores patients' risk of lung cancer based on analysis of six blood-based biomarkers to assist physicians with triaging high-risk patients to CT scans before symptoms present.

  • Ribomic planning Tokyo IPO

    Ribomic Inc. (Tokyo, Japan) is planning to raise Y2.7 billion ($26.3 million) through the sale of 1.2 million shares on the Tokyo Stock Exchange's Mothers in an IPO underwritten by Daiwa Securities and six other undisclosed banks. Ribomic expects to price the offering by Sept. 16 and to start trading on Sept. 25. The company is developing a preclinical pipeline of RNA aptamers, but declined to disclose details.

  • AbbVie secures loans for Shire acquisition

    AbbVie Inc. (NYSE:ABBV) secured L3.2 billion ($5.4 billion) in a term loan and $4 billion in a revolving credit facility to help fund its acquisition of Shire plc (LSE:SHP; NASDAQ:SHPG). AbbVie is buying Shire for about L32.3 billion ($54.1 billion) in a cash and stock deal slated to close next quarter (see BioCentury, July 21).

  • DEA to impose tougher restrictions on hydrocodone combos

    The U.S. Drug Enforcement Agency issued a final rule raising all hydrocodone combination products to a class II schedule from class III, where class I indicates the highest potential for abuse and class V the lowest. The change will place greater restrictions on hydrocodone combination products, including requiring written prescriptions that cannot be refilled. The final rule takes effect on Oct. 6.

    Last year, HHS formally recommended DEA raise hydrocodone combination products to the class II schedule. Pure hydrocodone products are already class II (see BioCentury Extra, Oct. 24, 2013).


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