Sixty-eight percent of 50 packaged baby food products contained "worrisome" levels of one or more heavy metals such as inorganic arsenic, cadmium, lead and mercury, and 30% may be a "potential health risk" if consumed daily, while all products had at least one heavy metal, according to a Consumer Reports study. The report also showed higher levels of at least one heavy metal, especially inorganic arsenic, in products with sweet potatoes and rice, while organic food products had similar odds of containing heavy metals compared with nonorganic products.
The FDA approved Teva Pharmaceutical Industries' generic version of Mylan's widely prescribed EpiPen allergy auto-injector for use in children and adults weighing more than 33 pounds. The drug, which is the first generic version of EpiPen, delivers epinephrine and is approved in 0.3 mg or 0.15 mg doses.
Wave Life Sciences' WVE-210201, being developed as a treatment for patients with Duchenne muscular dystrophy, received orphan drug and rare pediatric disease designations from the FDA.
Eisai's Lenvima, or lenvatinib, was approved by the FDA to treat patients with unresectable hepatocellular carcinoma in a first-line setting. The decision was backed by results from the REFLECT study, which showed statistically significant improvements in progression-free survival in patients when compared with sorafenib and Lenvima's noninferiority to sorafenib for overall survival, achieving a median overall survival of 13.6 months versus 12.3 months with sorafenib.
The FDA announced three initiatives as part of an effort to advance the development and safety of medical devices related to the current user fee reauthorization. The initiatives comprise releasing draft guidance on issuing certificates for devices exported from the US, establishing a summary reporting program to streamline device malfunction reporting and proposing a list of device accessories suitable for reclassification to Class I category.
Researchers found that the FDA's The Real Cost anti-smoking campaign prevented 175,941 at-risk adolescents ages 12 to 17 from becoming smokers from 2014 to 2016, yielding an estimated $31 billion in smoking-related cost savings. The findings were published in the American Journal of Preventive Medicine.
University of Bristol spinout Ziylo was acquired by Novo Nordisk in a deal that could exceed $800 million from an upfront payment and development, regulatory and sales milestones. Ziylo's early-stage synthetic glucose binding molecule platform will be used to develop glucose-responsive insulins.
Sen. Chuck Grassley, R-Iowa, announced that the Environmental Protection Agency will not pursue a plan of attaching renewable identification numbers to ethanol exports. Grassley said he hopes that plans the EPA has regarding the Renewable Fuel Standard will not further hurt Iowa farmers and agriculture communities.
Humira, Lyrica and Xeljanz spent $25 million each in TV ad dollars in July. Companies spent $165 million on TV pharma ads during the month, an increase from $155 million in June.
More people recall television drug ads better than digital ones, but consumers are more likely to ask their doctors for a specific drug after seeing a digital ad, according to a study by DRG Digital/Manhattan Research. Print, radio and billboard ads were behind TV and digital in terms of recall.
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