The FDA released draft guidance allowing drugmakers to test Alzheimer's disease therapies on patients even before the disease shows outward signs and saying the agency could approve the therapies based on biomarkers rather than proof they alleviate symptoms. The improvement of biomarkers, such as the amount of beta amyloid in the brain, or improvement in memory and thinking ability would be an acceptable study goal.
The FDA gave orphan drug status to Arrowhead Pharmaceuticals' ARO-AAT, which is being developed as a treatment for patients with a rare genetic liver disease.
Agios Pharmaceuticals' new-drug application for ivosidenib, which is being developed as a treatment for patients with isocitrate dehydrogenase 1 mutation-positive relapsed/refractory acute myeloid leukemia, was accepted for priority review by the FDA. The PDUFA date for the drug is Aug. 21.
Prometic Life Sciences' inter-alpha-inhibitor-proteins, which are indicated to treat premature infants with the bowel disorder necrotizing enterocolitis, were given orphan status by the FDA.
The FDA accepted for priority review Shire's supplemental biologics license application for Cinryze, which is indicated for pediatric patients with hereditary angioedema. The agency's action date for Cinryze's expanded indication is tentatively set for June 20.
Ipsen's Cometriq, or cabozantinib, was recommended by the National Institute for Health and Care Excellence for funding by the National Health Service as a therapy for adult patients with medullary thyroid cancer whose disease is unresectable, locally advanced or metastatic. The institute also backed Eisai's Lenvima, or lenvatinib, and Bayer's Nexavar, or sorafenib, for NHS funding as a therapy option for differentiated thyroid cancers that have continued growing or spreading after surgery and radioactive iodine treatment.
A voluntary recall was issued by J.M. Smucker for 27 different pet food products after media reports of contamination with low levels of pentobarbital in some of its Gravy Train dog food. Included in the recall were varieties of Gravy Train, Kibbles 'N Bits, Skippy and Ol' Roy dog foods.
Data from a 105-patient at-home pediatric study of Medtronic's MiniMed 670G hybrid closed-loop diabetes management system showed that compared with baseline data, less glycemic variability, hypo- and hyperglycemia was experienced by patients, with more time spent in the target blood glucose range. Medtronic included the data in its FDA submission to expand indication of the device for use in kids ages 7 to 13.
Stryker Neurovascular secured expanded clearance from the FDA for its Trevo stent retriever device for use in certain patients with ischemic stroke up to a day after the first appearance of symptoms. Previous clearance for the device was for treating patients six hours after symptom onset.
European regulators gave Edwards Lifesciences CE mark approval for its self-expanding transcatheter Centera aortic heart valve, which is indicated for the treatment of patients with symptomatic aortic stenosis who are at a high risk for open-heart surgery. The valve is intended to be delivered using a 14 French motorized delivery system and is retrievable and repositionable.
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