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.

WASHINGTON – Tangled webs of regulatory requirements and a murky lack of transparency are keeping several countries on the U.S. Trade Representative's (USTR) list of trade partners that bear watching when it comes to opening the door to American biopharmaceuticals and protecting their patents.

The record number of drug shortages in the U.S. could be a glass half-full/half-empty proposition for biotechs.

With two products in Phase III development running up R&D expenses, Keryx Biopharmaceuticals Inc. is looking to raise $33 million in a registered offering of 7 million shares at $4.70 per share.

Recruiting subjects for ongoing Phase III hepatitis C virus (HCV) trials just got a lot harder. Even if the FDA doesn’t step in and force a change in the standard-of-care control arms after last week’s Antiviral Drugs Advisory Committee meetings, companies testing their experimental drugs in conjunction with pegylated interferon and rebavirin (PR) vs. PR alone may find enrollment and retention challenging, especially for treatment-naïve subjects. In a three-arm study that includes PR alone, patients would be signing up for a 33 percent chance of a year of flu-like symptoms with a cure rate of about 45 percent, at best....