August 19, 2019
The FDA’s draft guidance on broadening eligibility criteria and increasing diversity in clinical trials needs more definition and depth, according to drugmakers, clinical trial organizations and patients responding to the agency’s call for comments on the document.
August 19, 2019
This monthly feature presents a variety of questions from clinical trial professionals with answers from WCG Clinical’s expert staff. To ask a question of WCG’s experts, click here: https://bit.ly/2XB9F6R.
August 19, 2019
The FDA has named five acceptable endpoints for trials of gastroparesis treatments in a draft guidance released last week.
August 19, 2019
This feature highlights changes in clinical research organizations’ personnel.
AmerisourceBergen
Leslie Donato has been named executive vice president and chief strategy officer at AmerisourceBergen. Donato was previously vice president of strategy at Bayer Pharmaceuticals.
August 19, 2019
| Company | Drug/Device | Medical Condition | Status |
|---|---|---|---|
| Coordination Pharmaceuticals Inc. | CPI-200 | advanced tumors | Phase 1 trial initiated enrolling 27 subjects |
| Rimo Therapeutics Inc. | RiMO-301 | advanced tumors | Phase 1 trial initiated enrolling 18 subjects |
| CStone Pharmaceuticals | BLU-667 | RET-altered non-small cell lung cancer (NSCLC), medullary thyroid cancer (MTC) and other advanced solid tumors | Phase 1 trial initiated |
| Bio-Thera Solutions, Ltd. | BAT2506 | rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis (AS) and ulcerative colitis | Phase 1 trial initiated enrolling 182 healthy volunteers |
| Mallinckrodt plc | MNK-6106 (L-ornithine phenylacetate) | hepatic (liver) cirrhosis and hepatic encephalopathy (HE) | Phase 2a trial initiated enrolling 48 adult male and non-pregnant female subjects with hepatic cirrhosis who have a history of at least two or more documented episodes of HE in the last 12 months – with one in the last six months – and who present with hyperammonemia at the time of screening |
| Kedrion Biopharma | 10 percent intravenous immunoglobulin | primary immunodeficiency diseases (PI) | Phase 3 trial initiated enrolling 50 subjects at 16 sites in the U.S. |
| binx health | binx io (first-of-kind, highly sensitive and specific, molecular point-of-care (POC) diagnostic testing platform) | chlamydia (CT) and gonorrhea (NG) | 510(k) clearance granted by the FDA |
| Regeneron Pharmaceuticals, Inc. | EYLEA (aflibercept) Injection 2 mg, single-dose, sterilized prefilled syringe | multiple retinal diseases, including wet age-related macular degeneration and diabetic eye diseases | Approval granted by the FDA |
| TB Alliance | Pretomanid Tablets in combination with bedaquiline and linezolid | Extensively Drug-Resistant Tuberculosis (XDR-TB) and treatment intolerant/non-responsive Multidrug-Resistant (MDR) TB | Approval granted by the FDA |
August 19, 2019
Twice monthly, CWWeekly provides featured listings of clinical research job openings, upcoming industry conferences and educational programs from JobWatch, CenterWatch’s online recruitment website for both clinical research employers and professionals.
August 12, 2019
Drawing objective conclusions from subjective measurements is a common challenge in pain management research and one that can lead to skewed results without a system to analyze data, spot problems and evaluate their impact.
August 12, 2019
The FDA’s Office of Good Clinical Practice responds to inquiries on a variety of trial-related subjects, providing answers on the agency’s official regulations as well as best practices. The following is one such question and answer excerpted from the CenterWatch publication, GCP Questions, FDA Answers.
August 12, 2019
This feature highlights changes in clinical research organizations’ personnel.
Accelerate Diagnostics
Accelerate Diagnostics has named Jack Phillips chief operating officer. Phillips previously served as president and chief executive officer at Roche Diagnostics.
August 12, 2019
WCG Clinical has acquired clinical trial services organization PharmaSeek LLC, including its PFS Clinical and PatientWise subsidiaries, WCG announced last week.
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