Teva Pharmaceutical Industries' generic version of mifepristone was granted tentative approval from the FDA. The drug is the active ingredient in Corcept Therapeutics's Korlym.
Mountain View, Calif.-based Beddr has announced the release of its FDA-registered consumer wearable, SleepTuner, which monitors a user's blood oxygen, heart rate, stopped breathing events, position, movement and awakenings during sleep using optical sensors and a three-axis accelerometer. The Bluetooth-enabled device, which is designed to be worn on the forehead, provides insights on how sleep quality can be improved and stores data in the Beddr Cloud until it syncs with the Beddr iOS mobile app.
The FDA's Center for Devices and Radiological Health has released final orders down-classifying six new device types, including putting wound autofluorescence imaging devices in class I. The orders down-classify five device types into class II (special controls): the intranasal electrostimulation device for dry-eye symptoms, hemostatic device for intraluminal gastrointestinal use, the positive airway pressure delivery system, the thermal vestibular for headache and the light-based energy source device for topical application.
Dublin, Ireland-based Allergan plans to submit a marketing application for its migraine therapy ubrogepant to the US early next year. Allergan recently finished two safety studies in which more patients treated with 50-mg and 100-mg doses of the drug experienced relief from pain and bothersome migraine-associated symptoms two hours after the initial dose, compared with those receiving placebo.
An early-stage study was launched in China by Hutchison China MediTech, or Chi-Med, to assess the preliminary efficacy, safety and pharmacokinetics of its experimental drug HMPL-523, combined with azacitidine, as a treatment for elderly acute myeloid leukemia patients who have not been previously treated or who are ineligible to undergo standard induction therapy. The study's primary endpoint includes overall response rate as well as adverse events.
Rocket Pharmaceuticals unveiled updated long-term results from a Phase I/II study being conducted in Spain to assess its gene therapy candidate RP-L102, indicated for patients with Fanconi Anemia, a rare, inherited hematologic disorder. The data were presented at the meeting of the European Society of Gene and Cell Therapy, which showed durable engraftment in four patients based on follow-up data for 12 months.
Based on post hoc analysis from its midstage SUSTAIN study, Novartis reported that nearly 36% of sickle cell patients treated with crizanlizumab, or SEG101, did not experience post-treatment pain crises, compared with 16.9% of patients given a placebo. Findings were published in the American Journal of Hematology.
AbbVie and Morphic Therapeutic will work together to develop the latter's antifibrotic integrins to block transforming growth factor β activation through various undisclosed targets. Under the deal, Morphic will receive $100 million up front plus potential licensing fees down the road from AbbVie for global development and marketing rights to the potential products of the research.
Scientists from University of California, Riverside used CRISPR-Cas9 technology to develop biotech mosquitoes that have decreased body size. Researchers shortened the mosquitoes' lifespan by altering their DNA sequences and modifying their gene function to postpone development.
Ethanol producing company Companhia Agricola Usina Jacarezinho received $13 million from the Brazilian Development Bank. The grant is expected to help the company improve its sugar processing capacity.
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