Alexion Gets A Bad Grade On An FDA Inspection
One of the darlings of the biotech industry has suffered a blow following an FDA inspection of its Rhode Island facility. Alexion Pharmaceuticals disclosed this morning that the agency issued a...
View ArticleAnother Day, Another Problem For Hospira
Like The Gang That Couldn't Shoot Straight, Hospira is encountering yet another manufacturing woe. Late last week, the drugmaker recalled a lot of sodium injectables after a customer identified several...
View ArticlePharmalot... Pharmalittle.. Good Morning
Hello, everyone, and how are you this morning? A shiny sun is hovering over the Pharmalot corporate campus where, as usual, we are scurrying about to deposit short people at school houses and officials...
View ArticleSocial Media Does Not Incur FDA Wrath, After All
For the past few years, one obsession in the pharmaceutical industry is the proliferation of social media tools and the lack of regulatory guidance from the FDA on how to use them without getting into...
View ArticleWho Said Anything About Good Manufacturing Practices?
A recent warning letter issued by the FDA to Asada Milling, an active pharmaceutical ingredient supplier based in Japan, may prompt you to ask whether a drug in which you have any type of interest...
View ArticleFDA, A Tuberculosis Drug And Surrogate Markers
Late last year, the FDA approved a first-in-class medication to treat multi-drug resistant tuberculosis. The agency did so after an advisory committee unanimously recommended accelerated approval for...
View ArticleJudge Rules Morning After Pill Restrictions Should Be Lifted
In what some are calling a landmark decision, a federal court judge has ruled that the morning after pill should be made available "without a prescription and without point-of-sale or age restrictions...
View ArticleA State Bill Over Drug Shortages Opens A Compounding Loophole
In the wake of the pharmacy compounding scandal that has led to 730 cases of fungal meningitis, including 51 deaths, across the country, pressure is being placed on both the FDA and state pharmacy...
View ArticleWaiter, There's Cardboard In My Sample: FDA Warns Pfizer Over Manufacturing...
In its latest bid to clamp down on wayward drug manufacturing, the FDA cited a Pfizer plant in Italy for violating some fairly basic procedures. The first involved problems with testing samples of...
View ArticleAnother State Smacks Down Biosimilar Legislation
Yet another state has rejected legislation that would make it more difficult to allow substitutions of biosimilars. This time, Maryland has declined to endorse the concept, which was advocated by some...
View ArticlePharmalot... Pharmalittle.. Good Morning
Hello, everyone, and how are you today? A shiny sun is hovering over the Pharmalot corporate campus, where we are busy with the usual early morning matters. As always, we are getting a fresh start with...
View ArticleWhat Adverse Events? Sales Reps Misinform Docs About Side Effects
There is little, if any debate that pharmaceutical sales reps are hired to sell. The operative word in the job title, after all, is ‘sales.’ But a new study raises concern that the promotional push is...
View ArticleThe Obama Budget, The FDA and Prescription Drugs
Earlier this week, when tech problems conspired to derail our communication with you, the Obama administration released its budget for Fiscal Year 2014. And we feel compelled to go on the record with...
View ArticleFDA To Review Controversial Avandia Clinical Trial In June
Nearly three years after the FDA greatly restricted use of the controversial Avandia diabetes pill over increased risks of heart attacks and strokes, the agency is convening a two-day meeting in June...
View ArticlePharmalot... Pharmalittle... Good Morning
Hello, everyone, and welcome to another working week. We hope the all-too-short weekend was invigorating, because that crushing routine of meetings and deadlines and what-not has now returned. Our own...
View ArticleFDA's Abrams: That Long-Awaited Social Media Guidance Is Coming
For the past few years, drugmakers have grappled with the Internet and how to promote their medicines to an increasingly interactive public. Although the FDA held a widely attended meeting in 2009 and...
View ArticleTroubled Compounders: What FDA Knew And When It Knew
After months of anticipation, a House committee is holding a hearing today to review a scathing report about the extent to which the FDA knew about the manufacturing issues at the New England...
View ArticlePharmalot... Pharmalittle.. Good Morning
And so, another busy day is on the way. With the barrage of tech problems we have been experiencing - notice some stories still lack images, for instance, among many other problems - we are reminded...
View ArticleReader Poll: Should FDA Have Barred Generic OxyContin?
In a highly controversial move, the FDA last night announced it would not approve generic versions of the older form of the OxyContin painkiller over concerns that the drugs would be susceptible to...
View ArticleFat Chance? FDA Loosens Reins On Vivus Diet Pill, But Is It Enough?
After considerable anticipation, the FDA has finally eased restrictions on how the Vivus diet pill can be made accessible. By amending a Risk Evaluation & Mitigation Strategy, or REMS, Qsymia can...
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