You think the drug shortage is a devil now Just wait around a few years ’Cause you ain’t seen nothin’ yet. When that biosimilar pathway begins to flash Those big green dollar signs, You’ll know, you’ll know, you’ll know, you just ain’t seen nothin’ yet. Those biosimilars will turn your heart away from the old drugs of yesterday. You’ll think you have it comin’, and you’ll want it that way. You’ll say big profits are good profits, so you’ll take what you can get. B-B-B-Baby, you ain’t seen n-n-n-nothin’ yet. Patients will go to the doctor, and he’ll tell them...

Free speech. Most of us take it for granted. Unless you’re a drug company, that is. Since the FDA doesn’t trust biopharma when it comes to drug promotion, the agency believes that, as the watchdog of public health, it’s justified in curtailing drugmakers’ First Amendment rights. The FDA has put teeth to its leash on speech by issuing warning letters, which can block pending drug approvals in the U.S. and abroad. In what it considers more egregious cases, the agency turns speech violations over to the Justice Department to prosecute. As we reported in BioWorld Today, several companies, rather than...

What's causing drug shortages in the U.S., and is it a matter of mechanisms of control or methods of drug production? In 2010, there were shortages of 178 drugs in the U.S., a record-high level. Many drugs on the 2010 list are still unavailable, and the number is growing. It has tripled in the last six years, according to the FDA. Currently there are about 246 drugs in short supply, and that number has risen steadily since 2006. Severe drug shortages are endangering cancer patients, heart attack victims, accident survivors and others. Many people hold the FDA largely responsible for...

As a biotech junkie, I’ll admit I was shocked to the core by Dendreon Corp.’s second-quarter admission that prostate cancer vaccine Provenge (Sipuleucel-T) is thus far not succeeding commercially. (See BioWorld’s news bulletin for details.) The most shocking part? Analyst and investor assumptions that Provenge’s poor performance is due not to reimbursement hurdles, as Dendreon claimed, but to an underlying lack of demand. Doctors and patients don’t want to use the product. Come again? Are you serious? Provenge is the first and only therapeutic cancer vaccine ever to gain FDA approval. I don’t have to tell anyone in the biotech...

Late last month, the American College of Radiology Imaging Network (ACRIN; Philadelphia) along with the National Cancer Institute’s Lung Screening Study Group released the results of the National Lung Screening Trial (NLST). The study supports the idea that CT Screening in older, heavy smokers can reduce mortality rates by 20% compared to standard chest X-rays.  Nearly 53,000 current and heavy smokers between the ages of 55 and 74 at 33 sites across the U.S. were enrolled in NLST. (See full study here) It should be pointed out however that the study results show that CT Screening in these patients turned up a high...

Disclosure and transparency. They’re recurring themes often sung by lawmakers and critics who would have us believe that even the gift of a drug-labeled pen will put doctors and medical students under the influence of biopharma. You’ve heard the refrain. Calls for disclosure on journal articles and citizen petitions. Reminders to disclose drug ties when testifying before Congress or an advisory committee. Requirements for doctors and researchers to disclose personal or family ties with industry when serving on an FDA advisory committee. What you haven’t heard are demands that biopharma critics disclose where they get their funding. And when’s the...

Earlier this month my wife and I had a beautiful baby daughter, and as you can imagine, the demands for pictures are flooding in.  This can be pretty problematic for us seeing as how we don’t really have a Facebook page, where we can disseminate pictures to all those who are requesting a glimpse of our lovely daughter's visage,  in one click of a button. Everything with us, is done by email or text messages. But there’s a reason for that, and a good one.  See we don’t really want our message out for the whole world to see. My wife and...

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...

Sometimes it’s tough for biotechs to figure out what, exactly, constitutes news. Yesterday, Cell Therapeutics Inc. issued a release stating the FDA had “concluded that accelerated approval of pixantrone NDA 022481 may not necessarily be out of reach based on a single controlled clinical trial.” Not until the second paragraph did readers find out the most important tid-bit: that the FDA had denied their appeal regarding the cancer drug, which received a complete response letter last year. Meanwhile, Vivus Inc. issued first quarter earnings late Monday, but the piece of news everyone was most interested in – the path forward...

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....