News

Industry Seeks More Detail from FDA Guidance on Trial Diversity

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The FDA’s draft guidance on broadening eligibility criteria and increasing diversity in clinical trials needs more definition and depth, according to drugmakers, clinical trial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.

Up and Coming from Aperiomics, Curis and OneOme

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.

New Pipeline Updates from CStone Pharmaceuticals, Mallinckrodt plc and TB Alliance

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

 

GCP Questions, FDA Answers: Transfer of Study Records

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.

Up and Coming from Astellas, Nimbus and Parexel

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.