The sleep cycle of zebrafish is similar to that of humans, with periods of slow burst and propagating wave sleep as well as some similarities to what's seen in humans during rapid eye movement, and the fish's brain and muscle signatures and sleep-regulating hormones are also similar to those found in mammals, researchers reported in Nature. The findings suggest that zebrafish might be good models for human sleep disorders and for testing sleep drugs.
LogicBio Therapeutics' gene-editing therapy candidate LB-001, indicated for methylmalonic acidemia, has been granted rare pediatric disease designation by the FDA. The therapy treats patients whose bodies are unable to break down some fats and proteins, which results in a methylmalonic acid buildup in the blood.
ARO-ANG3, a treatment being developed by Arrowhead Pharmaceuticals for the inherited disorder homozygous familial hypercholesterolemia, has received orphan drug designation from the FDA. An early-stage study for the drug is currently underway.
A Biologics License Application was submitted by Astellas Pharma to the FDA in a bid to seek accelerated approval for its drug enfortumab vedotin as a treatment for persons diagnosed with metastatic or locally advanced urothelial cancer previously treated with platinum-containing chemotherapy and a PD-1/PD-L1 inhibitor. The filing was based on data from a pivotal midstage trial.
Health Canada has approved Puma Biotechnology's Nerlynx, or neratinib, as an extended ancillary treatment for women with early-stage breast cancer who have completed prior adjuvant therapy with Roche's Herceptin, or trastuzumab. Knight Therapeutics, Puma Bio's licensee, will handle the product's commercialization.
Recursion Pharmaceuticals gained $121 million from a Series C financing round and will use the funds to advance its artificial intelligence-based drug development system to produce cellular images by the millions and use machine-learning software for data analysis to filter through possible therapeutic compounds.
A collaboration between Skyhawk Therapeutics and Roche subsidiary Genentech will develop RNA-targeting therapies for oncologic and neurological diseases. The only financial disclosure made regarding the deal was that it could total an estimated $2 billion over time.
AM-Pharma, based in the Netherlands, raised $131 million from a funding round that will support a clinical trial for its recombinant human alkaline phosphatase drug indicated as a treatment for sepsis-associated acute kidney injury. The candidate, recAP, will be tested in a late-stage clinical study involving 1,400 patients from 12 countries.
The use of biotech corn production could prove key to Kenya's food security agenda since biotech crops are herbicide-tolerant and pest-resistant, which may prove advantageous for farmers, particularly since biotech produce can ride out adverse weather conditions caused by climate change.
The government of the Canadian province of Ontario issued a proposal in late 2018 that it plans to require the use of E15 by 2025. Several ethanol groups in the US have sent in comments offering their technical expertise while also encouraging use of higher ethanol blends.
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