A Dallas-based pharmaceutical compounding company is disputing an FDA request to recall the sterile drugs it produced between June 2013 and May 2014, arguing that any contaminated products were quarantined, destroyed, and never released to the public. Full Story
D CEO magazine and D Healthcare Daily are pleased to recognize outstanding healthcare CEOs, practitioners, and other innovative industry leaders with the new Excellence in Healthcare Awards program. Full Story
The pharmaceutical company that makes the asthma drug Advair and the antidepressants Paxil and Wellbutrin will pay $105 million to Texas and 43 other states for misrepresenting the uses of its drugs. Full Story
Advocates say clinical trials are not representative of the racial makeup of the United States, which could mean that treatments approved by the Food and Drug Administration will have unforeseen complications on certain demographics. A national push begun this week is aiming to change that by increasing diversity in the trials. Full Story
The regimen requires just one pill a day, down from the standard of six daily pills and weekly shots. The drugs were approved in December of last year and have been administered in 10 clinical trials at UT Southwestern.
Less than two months after the departure of its president, layoffs have begun at Fort Worth-based pharmaceutical company Galderma, the company confirmed Monday. Full Story
The Food and Drug Administration last week approved a pill that is expected to make the treatment of hepatitis C easier, shorter, and more effective. Great, right? There is a downside, though: it costs $1,000 a day. The drug, Sovaldi, will allow some patients infected with the liver-destroying virus to be treated with pills only, doing away with weekly injections of a drug that is usually accompanied by debilitating side effects. That treatment can take up to a year and only cures about three out of four patients. Sovaldi is a daily pill that—in clinical trials—cured close to 90 percent of… Full Story
State officials have connected a Central Texas compounding pharmacy to a bacterial outbreak that sickened 17 patients in Corpus Christi hospitals earlier this year, the Associated Press reported. Officials said the most recent results showed a “genetic match” between the bacteria found in the product and bacteria in blood samples of 15 of the patients. The investigation continues and authorities have not concluded that Cedar Park-based Specialty Compounding is to blame for the illnesses. In September, an inspector—hired by Speciality Compounding—found no link to the infection, which has killed two patients.
Food and Drug Administration investigations have become second nature for Dallas-based USP Labs, after a recent look by the federal agency linked one of the company’s supplements to a hepatitis outbreak in Hawaii. The FDA issued a warning last week linking the company’s bodybuilding supplement OxyElite Pro to an outbreak of non-viral hepatitis. Nearly 30 patients have been hospitalized with acute heptatitis so far, two dozen of whom had used OxyElite Pro. Two of those have required liver transplants, and one has died. “The warning letter states that the products are deemed adulterated because they contain a new dietary ingredient (an ingredient… Full Story
UPDATE: From Galderma spokeswoman Virginie Naigeon: Francois Fournier has decided to leave his position as president of Fort Worth-based Galderma Laboratories, L.P. The company most recently announced the FDA approval of Mirvaso for the topical treatment of the facial erythema (redness) of rosacea. “I am proud to have completed the successful launch of Mirvaso, a game-changer in the treatment of patients suffering from rosacea. However, after an amazing 13 years with Galderma, I have decided it is time to pursue other professional opportunities and move on to the next phase of my career. This is not a decision that I have… Full Story