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11:37 AM, Aug 17, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Alnylam gets first RNAi drug approval

Twenty years after the scientific co-founders of Alnylam Pharmaceuticals Inc. (NASDAQ:ALNY) discovered RNAi, a drug using the modality has been approved. On Aug. 10, FDA approved Onpattro patisiran to treat polyneuropathy caused by hereditary transthyretin...
11:30 AM, Aug 17, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA approves Eisai's Lenvima for first-line HCC

FDA approved Lenvima lenvatinib mesylate from Eisai Co. Ltd. (Tokyo:4523) as first-line treatment of unresectable hepatocellular carcinoma (HCC). The approval was based on data from the Phase III REFLECT trial in patients with previously untreated, metastatic...
10:24 AM, Aug 17, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Regeneron, Teva’s anti-NGF mAb meets 16-week endpoints in Phase III for OA pain

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) and Teva Pharmaceutical Industries Ltd. (NYSE:TEVA; Tel Aviv:TEVA) said fasinumab met the co-primary endpoints at week 16 in a substudy of the larger Phase III FACT LTS & OA trial to...
10:24 AM, Aug 17, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

J&J, ViiV's two-drug regimen meets in Phase III for maintenance treatment of HIV-1 infection

ViiV Healthcare Ltd. (Brentford, U.K.) and Johnson & Johnson (NYSE:JNJ) said a two-drug regimen comprising cabotegravir and Edurant rilpivirine met the primary endpoint in the Phase III ATLAS trial as maintenance treatment in HIV-1-infected adults...
8:32 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Regulatory

Motif's antibiotic gets Priority Review

Motif Bio plc (LSE:MTFB; NASDAQ:MTFB) said FDA accepted and granted Priority Review to an NDA for iclaprim (MTF-100) to treat acute bacterial skin and skin structure infections (ABSSSIs). Its PDUFA date is Feb. 13, 2019. The...
8:32 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA accepts applications for Circassia COPD products Duaklir, Tudorza

Circassia Pharmaceuticals plc (LSE:CIR) said FDA accepted for review an NDA for Duaklir Pressair aclidinium bromide/formoterol fumarate to treat chronic obstructive pulmonary disease (COPD). The company also said the agency accepted an sNDA for Tudorza...
8:31 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Regulatory

FDA gives green light for Regeneron's 12-week Eylea regimen

Regeneron Pharmaceuticals Inc. (NASDAQ:REGN) said FDA approved an sBLA for an every 12-week dosing schedule of Eylea aflibercept to treat wet age-related macular degeneration (AMD). Eylea's updated label says patients may be treated with every 12-week...
8:30 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Preclinical Results

SOD1 antisense oligonucleotide improves survival in ALS model

Researchers at Biogen Inc. (NASDAQ:BIIB), Ionis Pharmaceuticals Inc. (NASDAQ:IONS) and colleagues reported data from a rat model of superoxide dismutase 1 (SOD1)-mutated amyotrophic lateral sclerosis (ALS) showing that a single bolus dose of intrathecal IONIS-SOD1Rx...
8:15 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

Realm's atopic dermatitis candidate misses in Phase II

Realm Therapeutics plc (LSE:RLM; NASDAQ:RLM) reported preliminary data from a Phase II trial in 122 patients with mild to moderate atopic dermatitis showing that PR022 missed the primary endpoint. Twice-daily topical PR022 for 28 days...
8:15 PM, Aug 16, 2018  |  BC Week In Review | Clinical News  |  Clinical Results

RegenxBio's AMD gene therapy well tolerated in Phase I

RegenxBio Inc. (NASDAQ:RGNX) said a single subretinal injection of RGX-314 was well tolerated with no treatment-related serious adverse events reported in a Phase I trial to treat wet age-related macular degeneration (AMD). RGX-314 is an...

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