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FDA issued a warning letter to Baxter International for making “misleading efficacy claims” about its lung drug Araplast NP, which is contraindicated in individuals with selective IgA deficiencies and prescribed to patients who are at increased risk of emphysema. FDA’s letter, dated Aug. 3, takes issue with claims in a brochure aimed at physicians that “overstates” the drug’s efficacy—specifically that it elevates blood levels of AAT above the protective threshold recommended by ATS/ERS standards when given at certain does levels. The brochure’s claims, the letter states, “misleadingly imply that there is substantial evidence or substantial clinical experience that this threshold is clinically meaningful when such is not the case.”
In the last two years, FDA has twice cited Baxter for similar violations. In April 2009, it sent the company a warning letter indicating that select promotional materials created in support of Tisseel (a fibrin sealant) were false or misleading. In July 2008, the Agency’s Office of Compliance and Biologics Quality (OCBQ) issued an untitled letter to the company over claims about its anti-inhibitor coagulant complex, Feiba VH. The letters are not legally binding, but FDA can follow them up with litigation if they are ignored. Read More
Like it or not (and frankly, I don’t), stakeholders are here to stay in European pharmaceutical affairs. Don’t get me wrong. I’ve no objection to democratic engagement, or to giving people with a legitimate interest a legitimate voice. It’s the word I object to. Partly on aesthetic grounds, because it is an ugly coining. But much more because it is one of these words that has now been appropriated by everyone to mean exactly what they want it to mean, irrespective of what it means to anyone else. Consequently, despite its almost mandatory inclusion in every discussion of contemporary pharmaceutical affairs, it has largely lost its meaning.
Pfizer Adds FoldRx to its Specialty Care Unit
Pfizer on Wednesday announced that it acquired a small rare-disease drug firm, FoldRx, for an undisclosed sum of money.
Pfizer spokeswoman Gwen Fischer told Pharm Exec that the deal came together in a matter of weeks, and that FoldRx will be fully incorporated into Pfizer’s research division. All of FoldRx’s employees are expected to become Pfizer employees when the deal is completed.
FoldRx made its name—literally—by discovering compounds that treat diseases related to protein misfolding, using a proprietary yeast-based target discovery platform. Its pipeline leader is tafamidis meglumine, a treatment for TTR amyloid polyneuropathy, which is a genetic neurodegenerative disease.
“Over the past five years the FoldRx team has successfully developed tafamidis from the bench stage to MAA submission,” stated Richard Labaudiniere, president and CEO of FoldRx, in a release. “Pfizer’s strong clinical and regulatory resources, global marketing reach, and commitment to the treatment of rare diseases will significantly enhance the ability to pursue the goal of efficiently bringing tafamidis to all patients affected by this devastating neurodegenerative disease.” Read More »