Samsung Bioepis to Initiate Phase 1 Clinical Trial of SB26 Ulinastatin-Fc Fusion Protein

INCHEON, Korea–(Business Wire)–Samsung Bioepis Co., Ltd. today announced it will soon begin a Phase 1 study to evaluate SB26 in healthy volunteers. SB26, also known as TAK-671, is a ulinastatin-Fc (UTI-Fc) fusion protein intended to treat severe acute pancreatitis. Non-clinical GLP safety studies performed in monkeys and rats supported early human studies with SB26. The […]

Science: Huge alcohol clinical trial collapses

Science: Huge alcohol clinical trial collapses

JOEL ACHENBACH Last updated 05:00, August 13 2018 Goran Kosanovic, Washington Post A 10-year, US$100 million study into alcohol fell over because it “could show benefits while missing the harms”. Pounding one alcoholic drink after another is bad for your health. Things get murkier when it comes to “moderate” drinking. What’s the limit? Can a health-conscious […]

RedHill's Clinical Trial Results Undermine Its Underwritten Offering

RedHill's Clinical Trial Results Undermine Its Underwritten Offering

Nasdaq-listed RedHill Biopharma Ltd. announced an underwritten offering of $25 million on Thursday, pricing its American Depositary Shares (ADS) at $6 each, under its current trading price of $6.5.   For daily updates, subscribe to our newsletter by clicking here.   Founded in 2009, Tel Aviv-headquartered and listed RedHill develops […]

Historic clinical trial to focus on use of MRI-guided focused ultrasound to open blood-brain barrier

Historic clinical trial to focus on use of MRI-guided focused ultrasound to open blood-brain barrier

The clinical trial is expected to include 15 brain cancer patients from the University of Maryland Medical Center. “Microscopic inert gas-filled bubbles” will be injected into each patient’s bloodstream. MRI then helps the doctors target a specific area of the tumor with ultrasound. Once opened, the blood-brain barrier is “disrupted” for four to six hours […]

Unreported clinical trial of the week: Liposomal Bupivacaine (Exparel) for postoperative pain control for open and …

Unreported clinical trial of the week: Liposomal Bupivacaine (Exparel) for postoperative pain control for open and …

Georgia Richards, Nick Devito, and Ben Goldacre describe another unreported trial that could be used to improve patient care The US FDA Amendments Act (FDAAA 2007) requires certain clinical trials to report their results onto ClinicalTrials.gov within one year of completion. Our FDAAA TrialsTracker shows all individual trials that breach this legal requirement. In each […]

Iterum Initiates SURE 1, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections

Iterum Initiates SURE 1, a Phase 3 Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections

Iterum Therapeutics (Nasdaq:ITRM), a clinical-stage pharmaceutical company developing antibiotics against multi-drug resistant pathogens, today announced its initiation of the first of three Phase 3 clinical trials. As quoted in the press release: “We are delighted to begin our first Phase 3 clinical trial for sulopenem early in the third quarter, consistent with our prior guidance. […]

Orphazyme announces enrollment of first patient in Phase III clinical trial of arimoclomol for ALS

Orphazyme announces enrollment of first patient in Phase III clinical trial of arimoclomol for ALS

Orphazyme A/SCompany announcement                                                                                                                   No. 10/2018                                                                                                                                        Company Registration No. 32266355                                                                           Primary objective is to determine efficacy of chronic treatment with arimoclomol compared to placebo over 76 weeks Results expected in H1 2021 Copenhagen, August 10, 2018 – Orphazyme A/S, a biopharmaceutical company dedicated to developing treatments for patients living with rare diseases, today announced that the first patient […]

FDA Drafts Guidance on Seamless Clinical Trials for Cancer Drug Developers

FDA Drafts Guidance on Seamless Clinical Trials for Cancer Drug Developers

The US Food and Drug Administration (FDA) on Friday released draft guidance to help sponsors design and conduct first in human (FIH) clinical trials that speed the clinical development of cancer drugs through multiple expansion cohort study designs. The guidance provides FDA’s thoughts on the characteristics of drugs and biologics appropriately suited for such an […]

MND Scotland Launches Clinical Trial to Assess Interleukin-2 in ALS Treatment

MND Scotland Launches Clinical Trial to Assess Interleukin-2 in ALS Treatment

MND Scotland has initiated a clinical trial to test the tolerability and effectiveness of interleukin-2 in the treatment of amyotrophic lateral sclerosis (ALS), also known as motor neurone disease (MND). The trial is now recruiting participants. Interleukin-2, which is used for treatment of some rare types of cancer, is a molecule that regulates specific components […]