18:10 , Oct 12, 2018 |  BC Week In Review  |  Clinical News

Phase II data for Merck's Btk inhibitor highlighted at ECTRIMS

Merck KGaA (Xetra:MRK) reported 24-week data from a Phase II trial to treat relapsing multiple sclerosis showing that evobrutinib (M2951) reduced the mean total number of gadolinium-enhancing T1 lesions by up to 2.7 over placebo....
12:15 , Oct 12, 2018 |  BC Extra  |  Clinical News

Phase II data for Merck's Btk inhibitor highlighted at ECTRIMS

Merck KGaA (Xetra:MRK) reported 24-week data from a Phase II trial to treat relapsing multiple sclerosis showing that evobrutinib (M2951) reduced the mean total number of gadolinium-enhancing T1 lesions by up to 2.7 over placebo....
17:49 , Aug 31, 2018 |  BC Week In Review  |  Clinical News

Priority Review for Alexion's long-acting PNH therapy

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN) said FDA accepted and granted Priority Review to its BLA for ALXN1210 to treat paroxysmal nocturnal hemoglobinuria. Its PDUFA date is Feb. 18, 2019. ALXN1210 is a long-acting humanized mAb targeting...
14:28 , Aug 20, 2018 |  BC Extra  |  Company News

Priority Review for Alexion's long-acting PNH therapy

Alexion Inc. (NASDAQ:ALXN) said FDA accepted and granted Priority Review to its BLA for ALXN1210 to treat paroxysmal nocturnal hemoglobinuria. Its PDUFA date is Feb. 18, 2019. ALXN1210 is a long-acting humanized mAb targeting complement...
23:07 , Jul 20, 2018 |  BioCentury  |  Regulation

FDA’s positive reinforcement

Companies are still sifting through a half dozen gene therapy guidance documents issued by FDA, but so far it appears the recommendations support the paths taken by some of the most advanced clinical candidates for...
21:44 , Jul 10, 2018 |  BC Innovations  |  Distillery Techniques

Biomarkers; other

TECHNOLOGY: Tissue markers; metabolomics; plasma markers; computational models Computational models based on profiles of the fecal metagenome, plasma and urine metabolites and the liver transcriptome could help diagnose hepatic steatosis in non-diabetic obese women. In...
21:41 , Jul 10, 2018 |  BC Innovations  |  Distillery Therapeutics

Cancer

INDICATION: Colorectal cancer; breast cancer Patient sample and mouse studies suggest inhibiting CNR2 or promoting MGLL expression could help treat colorectal and breast cancers. In tumor samples from 30 colorectal cancer patients, levels of CNR2...
18:15 , May 11, 2018 |  BC Week In Review  |  Clinical News

FDA panel backs volanesorsen approval

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12-8 to approve Waylivra volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) to treat familial chylomicronemia syndrome, a rare lipid disorder that results from lipoprotein lipase deficiency. The company...
22:09 , May 10, 2018 |  BC Extra  |  Company News

FDA panel backs volanesorsen approval

FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 12-8 to approve Waylivra volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) to treat familial chylomicronemia syndrome, a rare lipid disorder that results from lipoprotein lipase deficiency. The company...
20:05 , May 8, 2018 |  BC Extra  |  Company News

FDA reviewers question Akcea candidate's safety

FDA reviewers said volanesorsen from Akcea Therapeutics Inc. (NASDAQ:AKCA) will "almost certainly" require a REMS if approved, although even that step "may not be sufficient" to ensure the candidate's safe use due to risks of...