For those who are needle-shy, or who have ever had the pleasure of explaining to a hysterical 5-year old that the shot isn’t going to hurt THAT much, and besides, it’s for the good of public health, a needle-free shot sounds like a great idea.  FDA, however, disagreed, and issued a communication to that effect. Read more »

A few weeks ago, Representative Michele Bachmann (R-MN) made waves by claiming that the vaccine for human papillomavirus could have dangerous side effects. She retreated from her remarks after the American Academy of Pediatrics said that they had no scientific validity. Makers of biopharmaceuticals might feel vindicated, but a recent poll emphasizes that Bachmann is not alone in her views. Read more »

Every now and then, media headlines become excited by a new potential ‘cure’ for cancer. Usually, this excitement stems from the results of very early research, which often involves a vegetable. Tomatoes, broccoli, cabbage, sprouts and beetroot have all had their turn in the spotlight over the years. Read more »

The patent cliff is beginning to reduce Big Pharma’s sales figures as generic versions of branded drugs enter the market. Although FDA has remarked that pharmaceutical innovation is beginning to increase, not all companies are going to be able to market enough new drugs to make up for lost sales. So how will these vulnerable companies maintain their profits? Read more »

A dosage form that delivers several drugs, either at once or in succession, can have many benefits for patients. The administered drugs could have synergistic effects when delivered together, and the convenient dosage form could improve patient compliance. And, of course, reformulating several drugs for codelivery could help breathe new life into a company’s patents. All of these advantages came to mind when I learned about a multiple-compartment gel capsule developed at the Georgia Institute of Technology. Read more »

Attendant to the pharmaceutical industry’s intensification in biopharmaceutical product development is the need for more effective delivery systems for large molecules. Oral administration, the widely used and common method for small-molecule drug delivery, is not a viable option for biologic-based drugs, so how can parenteral drug delivery be improved to make it easier to administer and potentially more patient- friendly? One approach, intradermal microinjection, recently took a step forward with FDA approval of an influenza vaccine delivered via this method. Read more »

Deaths from unintentional overdoses of prescription drugs have reached epidemic proportions in the US, outnumbering deaths from motor vehicle crashes or suicides in 20 states. Approximately 27,500 people died from unintentional drug overdoses in 2007, driven to a large extent by prescription opioid overdoses. This is according to a press release from the University of North Carolina (UNC), referring to a publication in the Journal of Clinical Psychiatry describing the phenomenon, and offering advice to prescribers on how to deal with it.

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I just finished writing an article on over-the-counter (OTC) drugs and how their safety and market approvals are managed (look for it in the May issue of PharmTech). As a consumer, something stood out in my research. Read more »

Even more than visiting the exhibit floor, I enjoy attending the presentations at INTERPHEX, which will take place next week in New York. The sessions always reflect the current hot topics within the pharmaceutical industry, and this year is no exception. Observers have been predicting that vaccines will be the industry’s new growth area, so my eye was drawn to the various biopharmaceutical talks listed on the INTERPHEX schedule of events. Read more »

This week, vaccine manufacturers won increased protection from liability in a closely watched case before the US Supreme Court. In Bruesewitz v. Wyeth, the Court ruled that federal law prohibits patients who claim to have been injured by a vaccine from suing the manufacturer. Pfizer hailed the decision as a victory for public health, but its effect is to diminish patients’ recourse when they suffer harm from taking faulty products. Read more »