Your OTC Decongestant Meds May Not Work: FDA Is Investigating
Beginning Monday an advisory committee is discussing oral formulations of nasal decongestant phenylephrine, which trials say may not work at over-the-counter dosages. The same issue arose in 2007, but the FDA decided in favor of the medication.
ABC News:
FDA Advisory Committee Reviews Effectiveness Of Common Ingredient In Some Nasal Decongestants
Beginning Monday, a U.S. Food and Drug Administration advisory committee is meeting to discuss the effectiveness of the oral formulation of a very common nasal decongestant, phenylephrine. The decision could lead to this formulation of the drug being taken off the market. The ingredient under review is found in some forms of over-the-counter medications like Dayquil, Mucinex and Sudafed PE. All over-the-counter medications hold a designation as "generally recognized as safe and effective" by the FDA, but clinical trials have found that oral phenylephrine, or PE, does not improve nasal congestion any more than a placebo at the dosage marked for over-the-counter use. (Cobern, 9/11)
Gizmodo:
A Popular OTC Decongestant Might Soon Be Pulled From Shelves for Being Useless
This same question was debated in 2007. Though there was some evidence back then that oral phenylephrine might be ineffective, the advisory committee and FDA were ultimately convinced otherwise by the overall data as well as the arguments made by cold medicine makers, so the drug stayed put. However, the agency did state that it might reassess the decision in the future once more research was concluded. In 2015, the FDA was petitioned by researchers from the University of Florida to do just that, which has led to this new meeting. (Cara, 9/11)
On cancer drugs and vaccines —
Bloomberg:
Daiichi To File For US Approval Of New Lung Cancer Drug By March
Daiichi Sankyo Co. plans to file for US approval of its novel lung cancer drug by the end of March after the medicine showed a benefit in patients with advanced disease. Patritumab deruxtecan was given to non-small cell lung cancer patients who had seen their cancer progress despite extensive previous treatment efforts. About 30% responded to the drug in the mid-stage trial, according to a presentation at the World Conference on Lung Cancer held in Singapore. (Matsuyama, 9/12)
Reuters:
Moderna Ties Up With Immatics To Boost Cancer Vaccine Development
Moderna said on Monday it has struck a deal with German drug developer Immatics for developing cancer vaccines and therapies, and would pay $120 million in cash and additional milestone payments. Moderna said the companies would use Immatics' drug discovery platform to develop mRNA-based cancer vaccines, and also study its own cancer vaccine for use in combination with Immatics' cancer therapy IMA203. (9/11)
In other pharmaceutical developments —
CIDRAP:
Groups Call On Congress To Improve FDA's Veterinary Antibiotic Stewardship Efforts
Nearly 20 public health, environmental, and food safety groups last week sent a letter to US lawmakers calling for changes to federal legislation that would improve veterinary antibiotic stewardship. The letter urges Senate leadership to revise the Animal Drug User Fee Act (ADUFA) with specific changes that require the Food and Drug Administration (FDA) to measure and report on whether its antibiotic stewardship activities have actually improved the use of medically important antibiotics in livestock and poultry. The legislation, first passed in 2003, needs to be reauthorized every 5 years and is set to expire on September 30. (Dall, 9/11)
Axios:
Walgreens Settles Lawsuit With Theranos Patients For $44 Million
Walgreens settled a class action lawsuit on Sept. 6 with Theranos customers for $44 million, per court documents. Walgreens patients in Arizona and California who received fraudulent blood tests will be refunded for products that did not work, following prison sentences for the company's executives. (Rubin, 9/11)
Reuters:
Doctor Asks Court To Toss J&J Lawsuit Against Her Over Cancer Research
A medical researcher has asked a court to throw out a lawsuit that Johnson & Johnson filed against her over her 2019 study on the links between cosmetic talc products and cancer, saying that her research is sound and protected by free speech rights. Dr. Jacqueline Moline, who has served as a plaintiffs' expert in more than 200 cases alleging that J&J talc products caused patients to develop cancer, said in a Friday court filing in federal court in Trenton, New Jersey, that the lawsuit was an effort to "intimidate" scientific experts. (Knauth, 9/11)
Stat:
New Weight Loss Drugs Vying To Be The Next Wegovy Or Mounjaro
The exploding popularity of drugs like Wegovy and Mounjaro has propelled dozens of companies to develop their own obesity treatments, with most of them trying to emulate the same approach as the blockbuster products. Nearly 70 obesity treatments are in development, and about two-thirds use a similar mechanism as Wegovy and Mounjaro, according to the STAT Obesity Drug Tracker, a new database compiled by STAT. (DeAngelis and Chen, 9/12)
