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  • FDA accepts Teva's sNDA for pediatric QNASL

    JERUSALEM — Teva Pharmaeceuticals on Tuesday announced that the Food and Drug Administration accepted the company's supplemental new drug application for a lower dose QNASL (beclomethasone dipropionate) nasal aerosol, which is used for the treatment of seasonal and perennial allergic rhinitis in children ages 4 years to 11 years.

    QNASL, a waterless intranasal corticosteroid spray, is currently available to treat patients 12 years of age and older who show symptoms of seasonal allergic rhinitis and perennial allergic rhinitis, the company notes.

  • NYT: Pfizer testifies before British Parliament on AstraZeneca deal

    LONDON — Pfizer testified before British Parliament Tuesday regarding its proposed offer to acquire AstraZeneca, the New York Times reported. According to the report, British lawmakers challenged Ian Read, Pfizer CEO, on the company's commitment to keep jobs in the United Kingdom.

  • Bayer's Kogenate FS receives FDA approval

    WHIPPANY, N.J. — Bayer HealthCare on Monday announced that the Food and Drug Administration approved the company's new indication for Bayer's Kogenate FS antihemophilic factor VIII (recombinant) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

  • Lundbeck set to acquire Chelsea Therapeutics

    VALBY, Denmark and CHARLOTTE, N.C. — Lundbeck and Chelsea Therapeutics International last week announced an agreement under which Lundbeck will acquire Chelsea.  

  • Alaska legislature passes telemedicine bill

    JUNEAU, Alaska — The 28th Alaska Legislature in late April passed legislation that will allow patients to obtain over-the-phone or online consultations where physicians can diagnose and, if necessary, provide a prescription.  

    “Nowadays, much of our life is conducted online or over the phone,” said Rep. Lynne Gattis, R-Wasilla. “In this age where we can do almost everything with a smartphone, it should not be necessary to drive to the doctor’s office to have a physical consultation for many common ailments.”

  • Study: Flu vaccines prevent hospitalizations in seniors, even when vaccine effectiveness is low

    ATLANTA — A new study from the Centers for Disease Control and Prevention found that flu vaccines prevent flu-associated hospitalizations in people 65 years and older, even during seasons when vaccine effectiveness is low, the agency stated Friday. The study reinforces CDC’s existing recommendation for annual vaccination of adults 65 years and older who are at high risk for serious flu-related complications and often most-impacted by serious flu disease each year, resulting in hospitalization or death.

  • FDA approves sensor, mobile app designed to better control asthma, COPD

    MADISON, Wis. — Propeller Health, the FDA-cleared digital health solution for chronic respiratory disease, earlier this week announced that the Food and Drug Administration granted 510(k) clearance to market its latest generation of the Propeller platform, including a new sensor.

  • FDA approves Zontivity tabs

    SILVER SPRING, Md. — The Food and Drug Administration on Thursday approved Zontivity (vorapaxar) tablets, an anti-platelet agent that's designed to decrease the tendency of platelets to clump together to form a blood clot. Zontivity is the first in a new class of drugs called a protease-activated receptor-1 (PAR-1) antagonist, the agency said.

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