PHARMACY

Report: Number of drug approvals by FDA may increase

BY Alaric DeArment

NEW YORK — The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

Reuters quoted FDA Center for Drug Evaluation and Research director Janet Woodcock as saying the number of drugs approved gradually could increase, already having reached a “nadir.” The report noted that 12 drugs had won approval this year so far, and Woodcock speculated that the agency would approve more than the 21 it approved last year.

Indeed, such big drug companies as Pfizer, Merck and Bristol-Myers Squibb have been plowing money into research and development over the last couple of years in anticipation of the patent cliff, when several blockbuster drugs are expected to lose patent protection and face generic competition. They have made particularly heavy investments in the development of specialty drugs — treatments for rare, serious and chronic conditions, such as cancer, autoimmune disorders and genetic diseases — especially biologics.

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FDA OKs Sanofi Pasteur’s Fluzone Intradermal

BY Alaric DeArment

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.”

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Impax commences trial for investigational RLS treatment

BY Alaric DeArment

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.

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