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.
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....
When it comes to making biotechs toe the line on drug promotion, public guilt and humiliation aren’t working. Neither are multimillion-dollar corporate fines. They’re just the cost of doing business these days. And yanking an offending company’s Medicare participation hurts the patients whose health depends on the firm’s drugs. So how’s the government to keep biopharma on the straight and narrow? Make CEOs pay for the sins of their companies. In recent months, the FDA and the Departments of Justice and Health and Human Services have held corporate officers to the fire, banning them from the industry, imposing hefty personal...
WASHINGTON – In a split decision, a federal appellate court lifted a preliminary injunction Friday intended to keep the National Institutes of Health (NIH) from funding research involving human embryonic stem cells (hESCs).
The unanimous support of the FDA's Antiviral Drugs Advisory Committee Thursday for telaprevir as a treatment for hepatitis C virus (HCV) genotype 1 is good news for Vertex Pharmaceutical Inc., but it could change the game for HCV clinical trials that are ongoing or just getting started.
An FDA advisory committee began priming the pipeline Wednesday for new hepatitis C virus (HCV) treatments, voting unanimously to recommend approval of Merck & Co. Inc.'s boceprevir in conjunction with the current standard of care (SOC), pegylated interferon and ribavirin, to treat chronic HCV genotype 1.
