Skip to Content

Posts tagged with "Regulatory Affairs"

  • Business and Markets

    Arena, Lorcaserin, and the FDA

    I’ve been getting a lot of objections to my opinion on Arena’s obesity candidate lorcaserin. Specifically, the first level of the dispute seems to be whether or not the recent clinical trial results met the FDA’s criteria for efficacy or not. So, let’s look at the details. Here’s how Arena press-released the results of the… Read More
  • Drug Industry History

    Book Review Department

    For those who are interested, I have a review up at Nature Biotechnology of Reasonable Rx: Solving the Drug Price Crisis, a book that proposes an. . .interesting solution for reworking the drug industry. And as Fate would have it, I also have a review in the latest issue of Nature Chemistry of Drug Truths: Read More
  • Business and Markets

    Dendreon’s Revenge?

    Post updated below – DBL Dendreon is a company that’s really been through it, as have their investors. Many will remember the upheaval back in 2007, when the company showed what they felt were impressive results for their autologous prostate cancer immunotherapy Provenge, got a favorable reception from the FDA’s advisory panel, bu… Read More
  • Diabetes and Obesity

    A DPP-IV Compound Makes It Through

    After talking the other week about the problems that Takeda has had with their DPP-IV inhibitor for diabetes, it now appears that AstraZeneca and Bristol-Myers Squibb have made it through the same narrows with their own drug. Saxagliptin has met the FDA’s latest guidelines for cardiovascular safety, which (you’d think) will remove the b… Read More
  • Clinical Trials

    And While We’re Talking About Industry-Sponsored Studies. . .

    Last week’s discussions around here about the merits (and demerits) of pharma-industry research seem to be coming at what’s either a really good or a really bad time. Take a look at this Washington Post article on the handling of clinical data at AstraZeneca. These details have come up during a large array of lawsuits… Read More
  • Cardiovascular Disease

    Takeda Gets A Surprise

    DPP-IV is short for “dipeptidylpeptidase IV”, understandably, and we need a good abbreviation for it. It’s an important enzyme target for diabetes therapy, since under normal conditions it breaks down glucagon-like-peptide 1. Longer-circulating GLP-1 would actually do a lot of diabetics good, and people have actually made such proteins as sep… Read More
  • Regulatory Affairs

    More on Wyeth v. Levine and Preemption

    For those who want it, I have more thoughts on the Wyeth v. Levine pre-emption decision over at The Atlantic’s business site. Reading the decision, it looks less like a loss for the drug companies than a loss for the FDA, but see what you think. Read More
  • Current Events

    Wyeth v. Levine: Pre-emption Goes Away

    The idea of preemption in drug liability cases has been coming up a lot in recent years. If the FDA approves a drug, does that Federal-level approval stop liability suits at the state level, or not? The Supreme Court has ruled today in the Wyeth v. Levine case, which directly addresses this issue. And pre-emption… Read More
  • Regulatory Affairs

    We Won’t Stay Off The Radar Screen For Long, Y’Know

    And here’s an even more Macro topic: when do you think the new administration is going to turn its attention to the drug industry? That’ll be after this stimulus-bill business is settled, one way or another – and the only thing I’ll say about that, this not being the soapbox for my political opinions, is… Read More
  • Business and Markets

    Lilly Pays the Price

    Eli Lilly has been in trouble for some time now regarding off-label promotion of their antipsychotic Zyprexa – specifically, their sales reps seem to have gone around saying that it was useful in treating the dementia of Alzheimer’s patients, although there was no FDA approval for that indication. (Whether it actually is any good for… Read More
...222324