WASHINGTON – Google searches and all the chatter on social networking sites could become part of the adverse event analyses the FDA uses to gauge the safety of drugs and biologics once they're on the market.

Global in perspective, Aeras, a nonprofit product development partnership (PDP), is singular in its focus – developing the first new preventive tuberculosis (TB) vaccines in nearly a century.

RxBio Inc. has been hard at work building the funding bridge it's counting on to take its lead candidate, RX100, down the home stretch toward approval.

News of Friday's FDA approval of Merck & Co. Inc.'s Victrelis as the first new hepatitis C drug in more than a decade is being overshadowed by the impending approval of the next in line, Vertex Pharmaceutical Inc.'s Incivek.

Biopharma is often the scapegoat for the escalating cost of healthcare, especially when it comes to the price of brand drugs. But since it’s hard to put a price on health and a long life, what gets lost in this focus on the bottom line is the public return on investment (ROI). National Institutes of Health (NIH) Director Francis Collins made that case last week when he testified before a Senate appropriations subcommittee. “Due in large measure to NIH research [and better treatment], our nation has gained about one year of longevity every six years since 1990,” he said. But...

WASHINGTON – As the clock ticks down on the May 31 expiration of the Small Business Innovation Research (SBIR) program, the Senate is considering yet another continuing resolution to keep the program running while Congress tries to hammer out the details of a multiyear reauthorization.

WASHINGTON – The FDA approved Merck & Co. Inc.'s Victrelis Friday as the first new chronic hepatitis C treatment in more than a decade.

In the two months since the 9.0 Tohoku earthquake triggered a massive tsunami that ravaged much of Japan's eastern coast, several of the country's biopharmaceutical companies have worked around the clock to assess the damages and get their facilities back into production despite power outages and crippled infrastructure.

WASHINGTON – The FDA sees a $150,000 annual biosimilar product development fee as the solution to a unique challenge posed by the new 351(k) approval path.