Parasitic infections related to Del Monte's vegetable-dip trays and McDonald's salads have sickened 237 individuals in four states and 163 people across 10 states, respectively. The CDC has not confirmed that the two outbreaks are related.
HHS Secretary Alex Azar said President Donald Trump's pressure campaign to bring down drug prices is coming to fruition after five pharmaceutical firms announced they will be freezing drug prices this year and one announced plans to lower some prices. Pfizer, Novartis, Roche, Bayer and Merck KGaA have said they will not implement price hikes for the rest of the year, while US-based Merck said it will be rolling back prices for seven drugs, but critics said these announcements don't line up with Trump's promise that there would be massive, voluntary price cuts.
The FDA approved GlaxoSmithKline and Medicines for Malaria Venture's Krintafel, or tafenoquine, for the prevention of Plasmodium vivax malaria relapse in patients age 16 and up currently receiving antimalarial therapy for acute P. vivax infection. GSK received a tropical disease priority review voucher with the drug approval.
An app that augments existing care for children with dyspraxia will be launched by Irish medtech company Beats Medical. The app, which provides daily interactive games and technology-based exercises, can be adapted according to the child's age.
European regulators have granted Companion Medical CE mark approval for its insulin pen, InPen. The FDA-cleared device, which comes with an integrated diabetes-management iPhone app, delivers aggregated glucose, meal and insulin data, along with daily views, to aid in monitoring a patient's glucose adherence and control patterns.
Bayer said US sales of its Essure birth control device will be halted at the end of the year as it saw steep declines in sales during previous years. The company said women who have the implant can keep using it, while FDA Commissioner Scott Gottlieb suggested the same and noted that users experiencing device-related symptoms should consult their physicians as "[d]evice removal has its own risks."
The National Institute for Health and Care Excellence has recommended Advanced Accelerator Applications' Lutathera, or lutetium Lu 177 dotatate, for National Health Service funding as a treatment for patients with gastrointestinal and pancreatic neuroendocrine tumors. The decision was backed by additional evidence the company submitted regarding risk reduction of the drug and a price reduction.
Eli Lilly updated the label for Trulicity, or dulaglutide, to demonstrate the efficacy and safety of the drug in adult patients with type 2 diabetes who have moderate to severe chronic kidney disease. In the AWARD-7 trial, patients achieved comparable glycemic control with weight loss when treated with Trulicity 1.5 mg or 0.75 mg in combination with mealtime insulin lispro, compared with the basal-bolus insulin group.
Eisai's obesity drug lorcaserin was not associated with an increased risk for major adverse cardiac events, including nonfatal stroke, myocardial infarction and cardiovascular death, according to a postmarketing safety study mandated by the FDA. Researchers evaluated 12,000 overweight and obese patients from the CAMELLIA-TIMI 61 study and also found that taking lorcaserin 10 mg twice daily resulted in a reduced progression to type 2 diabetes among those without the condition at baseline, as well as an improvement in several cardiovascular risk factors, compared with those on placebo.
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