François Fournier Out As Galderma USA President

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

Conversation With: Galderma USA President Francois Fournier

In September, Fort Worth-based pharmaceutical company Galderma was granted Food and Drug Administration approval for Mirvaso, the only topical drug approved to treat [the facial redness of] rosacea. The drug is expected to generate as much as $100 million in revenue for the company, which also produces Cetaphil, a popular over-the-counter skin care line. We sat down with Galderma USA president Francois Fournier to discuss the product, and Galderma’s future. In broad terms, what does Galderma do? It’s a very unique company because we specialize only in dermatology. It’s only about the patients with skin conditions. The inception of the company… Full Story

Pharmacist Who Made New Texas Execution Drugs Wants Them Back

A Woodlands compounding pharmacist who provided eight vials of the drug pentobarbital to the Texas Department of Criminal Justice for use in executions now wants the drugs back, stating that he didn’t know his company’s name would be public information. According to Texas justice blog Grits for Breakfast, Jasper Lovoi, the owner and pharmacist-in-charge of The Woodlands Compounding Pharmacy, sent a letter to the state last week, requesting the drugs be returned: Based on the phone calls I had with Erica Minor of TDCJ regarding its request for these drugs, including statements she made to me, it was my belief that this information… Full Story

After it Runs Out of Lethal Injection Drugs, Texas Turns to Compounding Pharmacy

Texas has turned to a suburban Houston compounding pharmacy to replace its expired execution drugs, according to documents released to the Associated Press Wednesday. Compounding pharmacies custom-make drugs, but are not subject to federal scrutiny. Under new, proposed federal regulation, the Food and Drug Administration might soon have greater oversight over the pharmacies, monitoring them similarly to the way it regulates pharmaceutical companies. On Tuesday, a federal lawsuit was filed for three death row inmates who are challenging the use of the drugs, claiming the use of untested drugs during an execution would violate the U.S. Constitution’s protection against cruel and unusual punishment. “Use of… Full Story

Amgen Buying Cancer Drugmaker Onyx for $10.4 Billion

Although Amgen is the world’s biggest biotechnology company, the drugmaker has lacked a presence in one of the industry’s largest sectors: cancer drugs. On Sunday, that changed. The company agreed to buy Onyx Pharmaceuticals for close to $10.4 billion in cash, the Associated Press reported. The transaction is expected to close at the beginning of the fourth quarter, subject to regulatory approval. Amgen’s purchase ranks among the five biggest-ever takeovers of a biotechnology company, according to the New York Times. It’s also the second-biggest takeover in Amgen history, trailing only the company’s $17 billion deal for Immunex in 2002.

CVS Blocks Access to Painkillers for Certain Doctors

CVS Caremark has revoked the dispensing privileges of more than 36 health care providers that it has identified as having extreme patterns of prescribing high-risk drugs, Reuters reports. In an article published last week in the New England Journal of Medicine, the pharmacy company disclosed that the suspensions followed an analysis of prescriptions for hydrocodone, oxycodone, alprazolam, methadone, and carisoprodol that were filled at its stores between March 2010 and January 2012. From a database of close to one million providers, CVS identified several dozen prescribers with the highest rates of dispensing high-risk drugs. In one case, a doctor was prescribing on average more than… Full Story

Two Texas Patients Who Received Recalled Drug Die

Two Texas patients who developed blood infections after receiving a recalled drug have died, but state health officials have not found definitive proof to link the death to the drug, the Associated Press reports. Last week, the Food and Drug Administration recalled all products produced by Specialty Compounding of Cedar Park, in the wake of reports of bacterial infections affecting 17 patients at two Corpus Christi hospitals. Texas health officials are working with the Centers for Disease Control and Prevention, which is analyzing samples of the bacteria taken from the patients to see if they’re all the same strain and come from the same source. Results… Full Story

Texas Compound Pharmacy Recalls Products After Patients Develop Bacterial Infections

An Austin-area compounding pharmacy has recalled all its sterile products after 15 people who got calcium injections developed bacterial infections, the Food and Drug Administration announced Sunday. The FDA received reports of 15 patients from two Corpus Christi hospitals who received an infusion of calcium gluconate, supplied by Cedar Park-based Specialty Compounding. The patients then developed bacterial bloodstream infections, thought to be related to the infusions. The bacteria rarely infects people, but any infectious bacteria directly injected into the bloodstream or muscle can cause trouble. “Giving a patient a contaminated injectable drug could result in a life-threatening infection,” Dr. Janet… Full Story

FDA Investigation Prompts Dallas Supplement Maker to Destroy $8 Million Worth of Product

The Dallas-based manufacturer of two bodybuilding supplements has voluntarily destroyed its $8 million inventory of the products, the FDA announced Tuesday. In April, the FDA announced that the stimulant dimethylamylamine (DMAA) was an illegal dietary ingredient and could pose serious health risks to users. Regulators said the stimulant could elevate blood pressure and potentially lead to heart attacks. Later that month, Dallas-based USPlabs said that it would stop producing DMAA products and instead create products without the stimulant. But the company continued to distribute its remaining inventory of Jack3d and OxyElite Pro, the FDA announced, which prompted the agency to ask the company to destroy… Full Story

Generic Drug Makers Soon to Receive More Freedom, May Also Face More Liabilities

Beginning in September, generic drug companies will be allowed to make changes to their labels without Food and Drug Administration approval, a luxury previously reserved for brand-name drugs, the department announced earlier this month. Currently, generic drugs are only allowed to update the safety information on their labels if the FDA ordered the companies to do so, or the associated brand-name drug has done so. Once the new rule becomes law, though, generic drug manufacturers will face the same liabilities as brand-name drugs currently do. The FDA’s decision follows several Supreme Court rulings arguing that if generic companies are required to use… Full Story