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  • Teva names new president, CEO

    JERUSALEM — Teva has a named its next leader. The company on Monday announced the appointment of Kåre Schultz as its president and CEO, who will take over the position from Dr. Yitzhak Peterburg.

  • Sanofi gets tentative FDA approval for Humalog follow-on Admelog

    SILVER SPRING, Md. — The Food and Drug Administration recently granted tentative approval to Sanofi’s Admelog (insulin lispro injection, 100 units/ml), a rapid-acting human insulin analog. The drug, a follow-on biologic version of Lilly’s Humalog, is indicated to improve glycemic control in patients with diabetes. 
     
    The approval means that Admelog has met all requirements for the regulatory agency, pending any patent issues that have not yet been resolved. 
     

  • Novartis names successor to CEO departing in 2018

    BASEL, Switzerland — Novartis has chosen a successor to CEO Joseph Jimenez, who will be stepping down from the position in 2018 after 8 years in the position. The company has named its current global head of drug development and chief medical officer, Dr. Vasant Narasimhan, as CEO, effective Feb. 1, 2018.

    Jimenez joined Novartis in 2007, leading its consumer health division before becoming head of the Novartis Pharmaceuticals division. He will step down, effectivt Jan. 31, 2018 aand remain available until his retirement on Aug. 31, 2018.

  • Gilead to acquire Kite Pharma

    FOSTER CITY and SANTA MONICA, Calif. — In a deal estimated at roughly $11.9 billion, Gilead Sciences will be acquiring leading cell therapy company Kite Pharma for $180 per share, the companies announced last week. Among the potential treatments Gilead will acquire is Kite’s most advanced therapy candidate, axicaabtagene ciloleucel (axi-cel), a cancer-fighting therapy expected to be the first to market to treat refractory aggressive non-Hodgkin lymphoma, with a decision date of Nov. 29.

  • FDA approves new Rx treatment for urinary tract infections

    SILVER SPRING, Md. — The U.S. Food and Drug Administration earlier this week approved Rempex Pharmaceuticals' Vabomere for adults with complicated urinary tract infections, including a type of kidney infection, pyelonephritis, caused by specific bacteria.

    Vabomere is a drug containing meropenem, an antibacterial, and vaborbactam, which inhibits certain types of resistance mechanisms used by bacteria.

  • FDA approves Chemo Research's treatment for Chagas disease

    WASHINGTON — Earlier this week the U.S. Food and Drug Administration approved Chemo Research's New Drug Application for benznidazole. This is the first drug ever approved by the FDA to treat Chagas disease.

    Benznidazole is an essential medicine for Chagas disease, a parasitic disease that affects an estimated 6 million to 8 million people worldwide. In the United States, an estimated 300,000 people are living with Chagas disease. Previously, it was available through the Centers for Disease Control and Prevention, but was not FDA approved.

  • Eli Lilly to refile RA remedy to FDA

    INDIANAPOLIS — Eli Lilly and Incyte Corporation on Wednesday announced that, after discussions with the U.S. Food and Drug Administration in late August, Lilly will resubmit the New Drug Application for baricitinib before the end of January 2018. The resubmission package will include new safety and efficacy data.

  • PhRMA names new chief medical officer, EVP

    WASHINGTON — The Pharmaceutical Research and Manufacturers of America on Wednesday announced Richard Moscicki will join the organization as chief medical officer and EVP. He will lead the organization's science and regulatory advocacy efforts beginning in early October 2017.

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