An outbreak of yellow fever in southeastern Brazil has the country's health officials worried of the incident's potential to become an epidemic. The death toll stands at 30 people, with an estimated 110 diagnosed with the disease.
A draft guidance on biosimilar interchangeability has been issued by the FDA recommending that sponsors conduct at least one switching study to demonstrate the interchangeability of a proposed biosimilar with its reference product without reducing safety and efficacy. The guidance presented considerations for switching study design and analysis but did not provide a single data package because requirements will vary per product.
The first generic version of Jazz Pharmaceuticals' Xyrem, which was developed by Roxane Laboratories, has been approved by the FDA as a treatment for cataplexy and excessive daytime sleepiness in patients with narcolepsy.
The FDA has given orphan drug status to Remedy Pharmaceuticals' Cirara, an investigational treatment for severe cerebral edema in patients with acute ischemic stroke. The injectable drug inhibits Sur1-Trpm4 channels in the capillary endothelium.
Pulmatrix's preclinical PUR1900 has been granted a qualified infectious disease product designation by the FDA to treat fungal respiratory infections in patients with cystic fibrosis.
A second late-stage trial conducted by Allergan and Gedeon Richter on their oral uterine fibroids therapy, ulipristal acetate, demonstrated the drug's superior ability to reduce abnormal bleeding compared with placebo. The firms are now planning to file for FDA approval for the drug in the second half of the year.
The Scottish Medicines Consortium has endorsed four medicines for National Health Service use: Merck's Zepatier, or elbasvir-grazoprevir, as a treatment for chronic hepatitis C, and Keytruda, or pembrolizumab, to treat late-stage non-small cell lung cancer; Novartis' Exjade, or deferasirox, to remove excess iron in the body due to frequent blood transfusions in patients with myelodysplastic syndrome; and Allergan's Xydalba, or dalbavancin, as a treatment for adults with acute bacterial skin and skin structure infections.
Some packages of Pictsweet Farms Crunchy Breaded Okra produced by Pictsweet are under voluntary recall because the products might contain glass fragments; one minor injury was reported. The items affected were packed in 12-ounce packages with a "best if used by" date of Nov. 3, 2018, and UPC number 0 70560 98377 8.
European regulators have granted Medtronic CE mark approval for its CoreValve Evolut R 34 mm transcatheter aortic valve replacement system for use in intermediate-, high- or extreme-risk patients with severe aortic stenosis who have an annulus size ranging from 26 mm to 30 mm. The approval makes the device available to 20% to 25% of European patients with diseased aortic valves who fit into that category.
European regulators have given Intact Vascular CE mark approval for its Tack endovascular system for use in arterial dissection repair after below-knee percutaneous transluminal angioplasty. The implantable system, which can be used in arteries with diameters ranging from 1.5 mm to 4.5 mm, can now be used for tibial arteries between the knee and the ankle under the expanded indication.
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