About Pharmacy Blogs

What’s open and closed Monday

Monday, Labour Day, is a statuatory holiday so most stores, banks and government offices will be closed.

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Police track pseudoephedrine purchase

Police have a new approach to cracking down on meth makers in Iowa. An electronic tracking system for pseudoephedrine is now being used at drug stores.

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Generic drug shortage hits patients, doctors nationwide

A pharmacist counts pills in a pharmacy in Toronto. Photograph by: Mark Blinch, Reuters Shortages of a variety of prescription medications across canada have left doctors and pharmacists scrambling to find replacement drugs, and forced many patients to switch from treatments they had used successfully for years, health professionals say.

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Dell seeking $2.5M state tax incentive

Round Rock City Council members approved recommending Dell Inc. for up to $2.5 million in state tax incentives to retain 7,700 jobs at one of its headquarters buildings.

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US Labor Department’s OSHA forms safety and health partnership with Suffolk Construction and RI Building and Construction Trades Council

The Providence Area Office of the U.S. Department of Labor’s Occupational Safety and Health Administration today signed a site safety and health partnership with Suffolk Construction Co.

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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.”

According to Pfizer, the deal is a reflection of the company’s new business unit structure. The original intent of the business unit was to target specialized expertise in specific research areas.

“This particular transaction will add another important component to the specialty care business unit and investigation medicines for rare and orphan diseases,” Fischer said. “The company also compliments our neurosciences disease area, which is currently a part of Pfizer’s specialty care.”

Earlier this year, Pfizer created an orphan and genetic disease research unit charged with discovering diseases affecting fewer than 200,000 patients in the United States and fewer than 10,000 patients in the European Union.

Pfizer has been upfront with the general public in stating that one of the key ways it will drive growth in the next few years will be through strategic business development, focusing on small to mid-size business deals such as the acquisition of FoldRX.

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Baxter Receives Third FDA Warning for Misleading Promotional Material

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.

FDA told Baxter in the latest letter that it is “very concerned by your continued violative promotion of your products.” The agency requested that Baxter cease dissemination of the Araplast brochure and respond in writing about how it intends to bring its promotional material in line with the Federal Food, Drug, and Cosmetic Act.

Baxter reports that it has since sent a letter of response to FDA and put its promotional material for Araplast on hold. In a statement issued Aug. 31, the company said it “has confidence in the strength of its promotional review policies and procedures and a history of collaborating with FDA. [Baxter] will continue to work with FDA to ensure the company is in compliance with all relevant rules and regulations.”

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Hormone Products Poison Pets and Children

As more and more menopausal women use topical hormone creams for their health, the downside is they are dangerous for pets and children. The lotions, creams, sprays and gels that are applied to arms and legs are places on the body that dogs and cats tend to lick and children are exposed to when held or hugged.

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Your Emotional Debt

On the surface, everyday life has become much more comfortable than ever before. Yet people still lead lives of quiet desperation. The source of this desperation is repression, a sense that you cannot be what you want to be, cannot feel what you want to feel, cannot do what you want to do.
A [...]

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5 Fun Ways to Help Your Brain (Giveaway!)

Scientists used to think neural networks were hardwired early in life, and that we couldn’t change the way our brains worked. With the help of improved technology in brain scanning, this theory was thrown out. Researchers now see our brains as being more akin to the muscles in our body — we can build and [...]

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