Oramed Pharmaceuticals (NSDQ:ORMP) said today that the FDA scheduled an end-of-phase II meeting with the Jerusalem-based company for August 31. Oramed is developing an oral insulin capsule for the treatment of Type II diabetes. The company’s Phase IIb trial met primary and secondary endpoints, since the insulin capsule lowered patients’ blood sugar relative to a placebo. […]
Clinical Trials
Study: Dangerous medication errors are on the rise
According to a study published in Clinical Toxicology, researchers from Nationwide Children’s Hospital found there was a 100% increase in the rate of serious medication errors per 100,000 U.S. residents between 2000 and 2012. The team analyzed calls to Poison Control Centers across the U.S. and discovered that medication errors, those that happen outside of […]
Inotek recalibrates after drug fails in glaucoma trial
Inotek Pharmaceuticals (NSDQ:ITEK) said last week that its glaucoma drug failed in a Phase II trial. This marks the 2nd problem for Inotek’s drug this year, after it failed in a late-stage trial comparing it to a placebo in January. In response to the data, CEO David Southwell said in a statement that the company […]
Medtech stories we missed this week: July 7, 2017
From EnvisionTEC’s FDA approval to InVivo Therapeutics adding a new clinical site, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. EnvisionTEC wins FDA nod for 3D printing E-Denture material EnvisionTEC announced in a June 30 press release that it has received FDA approval for its E-Denture material […]
Aequus to launch trial for anti-nausea patch
Aequus Pharmaceuticals (CVE:AQS) said today that it won approval from Health Canada to launch a proof-of-concept trial to evaluate the bioavailability and safety of the company’s long-acting transdermal anti-nausea patch. The device is made up of a combination of pyridoxine and doxylamine. The traditional form is delivered orally up to 4 times per day. The […]
Diasome lands $30m to fund clinical trials of liver-targeted insulin
Diasome Pharmaceuticals said today that it inked a funding deal that could bring the company up to $30 million. The round was led by Medicxi and contributed to by JDRF T1D Fund, Black Beret Life Sciences and McDonald Partners. The Cleveland-based company said it plans to use the funds to support the clinical development of […]
Antibody could be first new mechanism of action for HIV treatment in 10 years
Theratechnologies (TSE:TH) said today that the FDA granted priority review to the biologics license application for ibalizumab as a treatment for multi-drug resistant HIV-1. If the monoclonal antibody is approved, it will be the first antiretroviral treatment with a new mechanism of action to be introduced in a decade. It would also be the only […]
Novo Nordisk touts late-stage trial data for Tresiba insulin injection
Novo Nordisk (NYSE:NVO) touted data today from 2 Phase IIIb trials comparing Tresiba insulin degludec to insulin glargine in adults with Type I and Type II diabetes. The results were published in the Journal of the American Medical Association. The Switch trials are the 1st double-blinded insulin trials to compare the hypoglycemia rates and risks in patients […]
Ipsen wins approval for gastroenteropancreatic neuroendocrine tumor drug
Ipsen (EPA:IPN) said today that Teijin Pharma Ltd. won approval from the Japanese Ministry of Health, Labor and Welfare for Ipsen’s Somatuline as a therapy for gastroenteropancreatic neuroendocrine tumors. The subcutaneous drug was approved in Japan in 2012 for the treatment of acromegaly and pituitary gigantism. The latest approval was supported by Ipsen’s pivotal Phase III […]
Medtech stories we missed this week: June 30, 2017
From ConforMIS touting its knee replacement study to Consulting Radiologists’s new breast cancer detection tool, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Study: Low-dose CT scanning improves Ankylosing Spondylitis assessment A new study has shown that low-dose computed tomography (LD-CT) is more sensitive than X-rays for monitoring […]