The FDA granted orphan drug status to Amylyx Pharmaceuticals' AMX0035, which is being developed as a treatment for patients with amyotrophic lateral sclerosis.
The WHO in a new report says not enough antibacterial drugs are under development to meet the threat of drug-resistant infections, noting that only eight of 51 in development can be termed novel treatments. "There is an urgent need for more investment in research and development for antibiotic-resistant infections including TB," said WHO Director-General Tedros Adhanom Ghebreyesus, who added that if the need isn't met, "we will be forced back to a time when people feared common infections and risked their lives from minor surgery."
Some animal-rights groups lobby to end research that could extend the healthy life spans of dogs, cats and livestock; help birds recover from disasters; and protect great apes, elephants and other endangered species, writes Foundation for Biomedical Research President Matthew R. Bailey. "Discouraging studies condemns animals to unnecessary suffering and death from preventable illnesses," Bailey writes. "Real animal lovers should be proud to support animal research."
The FDA approved a new label for Sun Pharmaceutical's Odomzo, or sonidegib, for use in patients with locally advanced basal cell carcinoma who are not candidates for radiation therapy or surgery, or whose carcinoma recurred following either of those procedures. The label includes long-term data from a midstage trial in which the drug showed sustained durable tumor response of 26 months without new safety concerns.
Ipsen received approval from the European Commission for its Xermelo, or telotristat ethyl, in combination with a somatostatin analogue, which is indicated to treat patients with carcinoid syndrome diarrhea who are inadequately treated with SSA therapy.
Vitamin Cottage Natural Foods Markets recalled the Natural Grocers brand of Organic Deglet Noor Dates Pitted because they could contain coconut that is not declared on the label. The recalled products were shipped to 45 Natural Grocers stores in 11 states.
A guidance was released by the UK's Medicines and Healthcare products Regulatory Agency to guide medical device makers and notified bodies on human factors and usability engineering. The document includes an overview of device standards and regulations, looks at different usability engineering strategies, details safety considerations and principles that improve use of the device, and includes tables comparing the new rules with the previous ones.
A study in JACC: Cardiovascular Interventions found patients undergoing standard transcatheter aortic valve replacement who received Claret Medical's Sentinel cerebral embolic protection device had a threefold lower incidence of all-cause mortality or stroke at one week, compared with controls. Use of the device in the 802-patient, single-site trial also demonstrated a 91.8% success rate.
The Eclipse 15.5 treatment planning system was launched by Varian Medical Systems after receiving 510(k) clearance from the FDA. The new version comes with Varian's multicriteria optimization technology and provides graphics processing unit support, as well as treatment planning support for the company's radiosurgery treatment, HyperArc HDRT.
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