Two recent news reports provided some good news for a change. First, FDA announced plans to award $2 million in grants for the development of pediatric medical devices. Read more »

Following up on last week’s post, it appears that the H1N1 flu vaccine is effective in older children, ages 10 to 17, based on preliminary results of an ongoing trial. This week, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, announced that early results of clinical studies of the vaccine “look promising.” Read more »

Last week, I wrote that the increased attention to biological drugs, which are mostly taken through injections, was spurring interest in needle-free and implantable delivery methods for vaccines. Research into alternative delivery methods for vaccines could produce innovative ways of delivering other kinds of drugs as well, and I recently read about an inspired idea that a team of Boston researchers had for delivering intermittent doses of drugs. Read more »

The US Food and Drug Administration approved on Tuesday four H1N1 flu vaccines that demonstrated in clinical studies that a single dose produced a strong immune response in healthy adults after 8–10 days. Based on the manufacturers’ production schedules, things seem to be on track for vaccines to be available in four weeks.

But clinical trials of the vaccine are still underway on pregnant women and children, two groups that the Centers for Disease Control and Prevention (CDC) says are especially vulnerable to the H1N1 flu. Read more »

Got a Form 483? Then you’ve got 15 days. Starting today, FDA will enforce its program that calls for a more timely review of its Form 483 Inspectional Observations. Under this program, a company has 15 days to respond to the observations cited in the agency’s Form 483, before the agency decides whether to issue an official warning letter. The goal of this program is to optimize FDA’s already strained resources and to move firms to promptly correct noted violations. Read more »

Have you ever considered getting a flu shot but quailed at the sight of the needle? Lots of people hate getting injections, but this delivery method is still the predominant technique for administering biological drugs. Rising demand for vaccines and other biologicals is one factor spurring manufacturers to seek alternative delivery methods that could one day rescue the needlephobic. Read more »

The 2009 PDA-FDA Joint Regulatory Conference opened this morning in Washington, DC, with a keynote address by Dr. Joshua Sharfstein, principal deputy commissioner at the US Food and Drug Administration. Read more »

Following President Barak Obama’s address on healthcare reform to a joint session of Congress this week, the pharmaceutical and biotechnology industries reiterated their overall support for healthcare reform. Although not commenting in detail on specific measures offered by the President or Congressional proposals, the pharmaceutical and biotechnology industries will be important players in the upcoming weeks and months as the final proposals for healthcare reform materialize. Read more »

Efforts toward drug formulations that take into account genetic makeup will require a new examination of how disease develops in the body, thereby making it possible to connect biology with the chemical functions of a drug’s active ingredient. Read more »

As Congress prepares to reconvene next week, healthcare reform will be the number one item on the policy agenda. The White House announced this week that President Barack Obama will address a joint session of Congress, next Wednesday, Sept. 9. His speech, perhaps signaling more direct involvement by the President in proposals to revamp the country’s healthcare system, represents a critical juncture in the healthcare debate and yet-to-be determined implications for the pharmaceutical industry. Read more »