A draft guidance has been issued by the FDA in hopes of improving cybersecurity protection for medical devices through the update of recommendations for device design, labeling and documentation, as well as the enhancement of the premarket review process. The guidance, which replaces the first one released by the agency four years ago, covers de novo requests, premarket notifications, product development protocols, premarket approval applications and humanitarian device exemption applications.
Axsome Therapeutics' narcolepsy candidate AXS-12 was given orphan drug status by the FDA. The company intends to launch a midstage trial of the drug in the fourth quarter and expects top-line data next year.
The FDA granted breakthrough therapy designation to Kadmon Holdings' KD025, which is being developed to treat chronic graft-versus-host disease in patients who do not respond to at least two prior lines of systemic therapy. The company is currently recruiting patients for a midstage study of the drug.
Albireo Pharma's late-stage A4250, developed to treat patients with progressive familial intrahepatic cholestasis, was granted fast-track status by the FDA. The candidate also has rare pediatric disease and orphan drug designations for said indication.
One lot of dietary supplement Zero Xtreme capsules, which is intended for weight loss, has been recalled by Fat Burners Zone because it contains appetite suppressant sibutramine, making the supplement an unapproved drug. The recalled product has the lot number 1220062085, expiration date of 03/2020 and was sold across the country and over the internet.
A New Drug Application was submitted by Daiichi Sankyo with Japan's Ministry of Health, Labor and Welfare to obtain marketing approval for its drug quizartinib, indicated to treat adults with relapsed/refractory FLT3-ITD acute myeloid leukemia. Data from a midstage study of quizartinib in Japan, which was ended prematurely because the endpoints were met, were presented at the 80th Annual Meeting of the Japanese Society of Hematology.
An initial public offering brought in $46 million for cardiopulmonary company PhaseBio Pharmaceuticals. The company has ongoing Phase Ib study for PB1046 in patients with pulmonary arterial hypertension and is planning upcoming Phase IIa and Phase II studies of Fab antibody fragment PB2452.
The U.S. Department of Agriculture Animal and Plant Health Inspection Service lifted the regulatory prohibition on farmers' cultivation of biotech cotton plants. These plants are developed using RNA interference to eliminate the toxic chemical gossypol from the cottonseeds, making them edible for people.
Boston Scientific has announced completion of its acquisition of Augmenix, valued at $500 million in cash upfront plus $100 million in sales-based milestones. Augmenix makes the SpaceOAR hydrogel system, which separates the rectal wall from the prostate during prostate cancer radiation treatment and could generate sales of $50 million this year and nearly $90 million in 2019.
The Biomedical Advanced Research and Development Authority has awarded Mallinckrodt's Stratatech $26 million in additional funding for pediatric studies and continued development of its StrataGraft engineered skin tissue. Stratatech, which hopes to further develop its product as a medical countermeasure for large-scale burn incidents, now has around $86 million in total funding and could secure $74 million more for the project.
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