President Donald Trump urged Attorney General Jeff Sessions to file a lawsuit against certain manufacturers of opioid painkillers and to take action against foreign companies, particularly in China. Trump didn't specify which companies he wants to sue, but a number of states have already filed cases against opioid makers such as Purdue Pharma, alleging they contributed to the opioid abuse crisis.
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.
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.
SPR Therapeutics secured clearance from the FDA for its SPRINT endura (single lead) and extensa (dual lead) Peripheral Nerve Stimulation systems for pain management. The platforms, which are indicated for use in the extremities or the back for up to 60 days to treat acute and chronic pain, enable two leads attached to a wearable pulse generator to be implanted by physicians during an outpatient procedure.
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 The initiatives comprise releasing draft guidance on issuing certificates for devices exported from the US, establishing a summary reporting program to streamline device malfunction reporting and proposing a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.
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.
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.
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