Carcinogen Contamination Halts Sales Of Smoking-Cessation Drug
Some lots of Pfizer's Chantix pill were contaminated with high levels of nitrosamine, causing a global halt in sales. In other news, regulators approved Roche's covid treatment drug Actemra in the U.S., and the CDC backs use of a controversial dengue vaccine.
Stat:
Pfizer Halts Global Distribution Of Smoking Cessation Pill
After finding potential carcinogens in some lots of Chantix, Pfizer (PFE) late last month halted worldwide distribution of smoking cessation pill. The drug maker, which is now running tests, took this step after finding nitrosamine levels that were above an “acceptable” daily intake, according to the company. Consequently, regulators in Canada and South Korea, for instance, have posted recall notices for the medicine, which is called Champix outside the U.S., is recalled. Pfizer also sent letters to distributors about its actions. (Silverman, 6/24)
In other pharmaceutical news —
Reuters:
U.S. Approves Roche Drug For Emergency Use Against Severe COVID-19
U.S. health regulators have approved Roche's arthritis drug Actemra for emergency use to treat hospitalized COVID-19 patients, giving an extra boost to a medicine that was already allowed to be administered on compassionate grounds. The U.S. Food and Drug Administration (FDA) said on Thursday it had issued an emergency use authorization (EUA) for Actemra to treat adults and pediatric patients hospitalized with COVID-19. (6/25)
Bloomberg:
Tamiflu-Like Drugs Face Long Odds Against Covid ‘Runaway Train’
The flu fighter Tamiflu is one of the most recognizable antiviral medications in the world -- but its weaknesses suggest that devising a similarly simple treatment for Covid-19 will be challenging. After spending some $20 billion to develop vaccines at top speed, the U.S. is turning its attention to treating Covid-19 after a person is infected. Last week, health officials said the Antiviral Program for Pandemics will use $3.2 billion to target drugs for Covid and other viruses with the potential to foment pandemics. (Torrence, 6/24)
Stat:
CDC Advisory Panel Backs Use Of Dengue Vaccine In High-Risk Areas
An expert panel voted Thursday to advise that the Centers for Disease Control and Prevention recommend use of a controversial dengue vaccine, despite the fact that it can only be given to a small fraction of U.S. children and requires a pre-vaccination test in order to be used safely. The 14-0 vote by the Advisory Committee on Immunization Practices clears the way for rollout of Sanofi’s three-dose Dengvaxia vaccine, assuming the CDC accepts the advice. The CDC very rarely overrides recommendations from the group, known as ACIP. (Branswell, 6/24)
The New York Times:
New Therapy For Aggressive Prostate Cancer Improves Survival
An experimental therapy has prolonged life in men with aggressive prostate cancer that has resisted other treatments, offering new hope to patients with advanced illness and opening the door to a promising new form of cancer therapy. Among men who received the new therapy, there was a nearly 40 percent reduction in deaths over the course of the clinical trial, compared with similar patients who received only standard treatment, researchers reported on Wednesday. (Rabin, 6/24)
Axios:
The Growing Global "Infodemic" Around Stem Cell Therapies
An industry centered around unproven stem cell therapies is flourishing due to misinformation. Stem cells offer a tantalizing potential to address a large number of diseases, like Parkinson's, ALS, cancers and bodily injuries. But only a small number of therapies have been found safe and effective through clinical trials, while misinformation continues to proliferate. (O'Reilly, 6/24)
Also —
Modern Healthcare:
CVS Wins California Drug Overcharge Trial
CVS Pharmacy on Wednesday was cleared of allegations that it overcharged multiple classes of insured customers by more than $121 million for generic drugs. The individually insured customers representing classes from six states alleged that by not reporting its discounted prices for health savings pass program members as its "usual and customary" prices, CVS was in violation of state consumer protection statutes. However, a federal jury in California unanimously absolved CVS of these claims after less than a day of deliberation. A CVS spokesperson said the company was pleased with the verdict. (Devereaux, 6/24)
The New York Times:
Ei-Ichi Negishi, Nobel Prize Winner In Chemistry, Dies At 85
Ei-ichi Negishi, who shared the Nobel Prize in Chemistry in 2010 for developing techniques now ubiquitous in the manufacture of pharmaceuticals, died on June 6 in Indianapolis. He was 85.His death, at a hospital, was announced by Purdue University, where Dr. Negishi was a professor for four decades. No cause was given. (Chang, 6/24)
