The FDA has moved to October the PDUFA date for Janssen Pharmaceuticals' Invokana, or canagliflozin, being developed to reduce major cardiovascular event risk in adult patients with type 2 diabetes.
A biologics license application was resubmitted to the FDA by Amgen for Evenity, or romosozumab, being developed to treat postmenopausal women with osteoporosis who are at high risk of fracture. The filing included results from late-stage studies ARCH and BRIDGE.
The FDA approved Siga Technologies' TPOXX, or tecovirimat, as a treatment for patients with smallpox. The agency also approved a seven-year expiry for the drug and granted a material threat medical countermeasure priority review voucher to the company.
The FDA has granted Gala Therapeutics investigational device exemption approval to initiate an early feasibility study of its RheOx chronic bronchitis treatment system. The study aims to include up to 15 patients and five US sites.
The FDA issued an alert saying that pet foods that contain peas, lentils, other legume seeds or potatoes as main ingredients may be linked to canine dilated cardiomyopathy. Certain essential amino acids are not present in adequate amounts in plants such as peas, potatoes and lentils, creating an imbalance that can lead to DCM.
Researchers in India created a computer-assisted cognitive remediation application that assigns training tasks to patients with schizophrenia who have cognitive deficits to help improve their motor skills. The app, which is available offline and still has to be released online, is being used by 18 patients on tablets at Disability Assessment Rehabilitation and Triage.
An Australian study in Lancet found robot-assisted prostatectomies for treatment of urinary and erectile dysfunction and prostate cancer demonstrated no difference with standard, open prostatectomies in terms of safety, although it was associated with a lower increase in prostate-specific antigen levels at two years. The findings were based on surgical outcomes for about 300 men.
Data from a study of 894 treatment-naive patients with chronic hepatitis B who received Bristol-Myers Squibb's Baraclude, or entecavir, revealed that medication nonadherence upped the risk of these patients developing hepatocellular carcinoma and cirrhotic complications and increased risk for all-cause mortality, according to the study in The American Journal of Gastroenterology. Findings showed 296 patients had complete adherence, with the mean adherence rate being 89.1%.
Aurobindo Pharma will purchase Apotex's commercial operations and supporting infrastructure in Belgium, the Czech Republic, the Netherlands, Poland and Spain, plus a portfolio including more than 200 prescription drugs and 88 over-the-counter products.
A Series A funding round brought in about $15.7 million for Swedish biotech Modus Therapeutics, which the company will use to support clinical development of its lead candidate sevuparin, indicated for sickle cell disease. The Phase II study is expected to be completed in October.
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