FDA OKs Sanofi Pasteur’s Fluzone Intradermal
SWIFTWATER, Pa. — Sanofi’s vaccines division has won Food and Drug Administration approval for a vaccine designed for injection into the skin, the company said Tuesday.
Sanofi Pasteur announced the FDA approval of Fluzone Intradermal (influenza virus vaccine), which injects the vaccine into the skin via a short, fine needle, also known as a microinjection.
“The microinjection delivery system utilized in Fluzone Intradermal vaccine provides reliable and easy delivery of the vaccine into the dermal layer of the skin, an attractive site for immunization,” Sanofi Pasteur president and CEO Olivier Charmeil said. “Sanofi Pasteur is proud to bring this innovation in influenza vaccine administration to the U.S., offering healthcare providers a new tool that may help enhance adult influenza immunization rates.”
Impax commences trial for investigational RLS treatment
HAYWARD, Calif. — The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.
Impax Pharmaceuticals, as the division is known, said it filed an investigational new drug application with the Food and Drug Administration for IPX159 and started a phase-1 study.
The company will test several formulations of the drug on healthy volunteer subjects and start a phase-2b study in RLS patients in fourth quarter 2011 after it finds the proper formulation, based on results of the phase-1 study.
Bayer’s regorafenib granted fast-track review
WAYNE, N.J. — The Food and Drug Administration will expedite its review of an investigational drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the gastrointestinal tract, the company said Tuesday.
Bayer announced that the FDA had granted fast-track designation to BAY 73-4506 (regorafenib), designed to treat patients with gastrointestinal stromal tumors whose disease has spread to other parts of the body or whose tumors can’t be removed through surgery, and whose disease has progressed despite treatment with other drugs. The FDA grants fast-track designation to aid the development and expedite review of drugs that treat serious diseases and fill an unmet medical need.
“There is an unmet medical need for this specific patient population,” Bayer HealthCare Pharmaceuticals head of global development Kemal Malik said. “This milestone is an important step in the overall development of regorafenib.”