Human Trials

19 Sep 2019
- Clinical Trials
- Human Trials
Graybug Vision initiates clinical trial in macular edema secondary to diabetic macular edema or retinal vein occlusion

By PBR Staff Writer

Graybug Vision, a clinical stage pharmaceutical company developing potentially transformative long-acting therapies for ocular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), retinal vein occlusion (RVO), and primary open angle glaucoma (POAG), announced the initiation of its Phase 2a study with GB-102 in patients with macular edema (ME) secondary to DME or RVO.
19 Sep 2019
Clinical Trials
Human Trials
Novartis’ Cosentyx meets primary endpoint at Week 16 in PREVENT trial

By PBR Staff Writer

Novartis said that the phase 3 trial of its psoriasis drug Cosentyx (secukinumab), called PREVENT, in patients with non-radiographic axial spondyloarthritis (nr-axSpA), has met its primary endpoint at Week 16.
18 Sep 2019
Clinical Trials
Human Trials
Concert Pharmaceuticals completes enrollment in second open label trial of CTP-543 in alopecia areata

By PBR Staff Writer

Concert Pharmaceuticals announced that it has completed patient enrollment of an open label clinical trial to evaluate once-daily 24 mg compared to twice-daily 12 mg oral dosing of CTP-543 in patients with alopecia areata.
18 Sep 2019
Clinical Trials
Human Trials
Poxel initiates phase 1b multiple ascending dose trial for NASH drug candidate

By PBR Staff Writer

POXEL, a biopharmaceutical company focused on the development of innovative treatments for metabolic disorders, including type 2 diabetes and non-alcoholic steatohepatitis (NASH), today announced the initiation of a Phase 1b double-blind, randomized, placebo-controlled study in healthy subjects to evaluate the safety, tolerability and pharmacokinetics (PK) as well as support dose selection for a pivotal study of PXL065.
17 Sep 2019
Clinical Trials
Human Trials
Alnylam initiates APOLLO-B phase 3 study of patisiran for treatment of transthyretin amyloidosis with cardiomyopathy

By PBR Staff Writer

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the Company has initiated APOLLO-B, a global Phase 3 placebo-controlled clinical trial of patisiran, an intravenously administered RNAi therapeutic, for the treatment of transthyretin amyloidosis (ATTR amyloidosis) with cardiomyopathy.
16 Sep 2019
Clinical Trials
Human Trials
Arrowhead presents initial top-line clinical data and preclinical data on RNAi candidates ARO-APOC3 and ARO-ANG3

By PBR Staff Writer

Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today presented initial top-line clinical data at The Global Summit on Cardiology and Heart Diseases, being held in Dubai, UAE
16 Sep 2019
Clinical Trials
Human Trials
Novartis’ RMS drug ofatumumab achieves primary endpoints in phase III studies

By PBR Staff Writer

Novartis’ ofatumumab (OMB157) has achieved the primary endpoints in two phase III trials of relapsing multiple sclerosis (MS).
13 Sep 2019
Clinical Trials
Human Trials
Celgene’s QUAZAR AML-001 trial of CC-486 meets primary and key secondary endpoints

By PBR Staff Writer

Celgene Corporation has announced top-line results from the international phase 3, randomized, double-blind, placebo-controlled study, QUAZAR AML-001.
12 Sep 2019
Clinical Trials
Human Trials
VBI Vaccines announces phase 2a trial of VBI-1901 plus AS01B adjuvant system in recurrent glioblastoma

By PBR Staff Writer

VBI Vaccines has announced a collaboration with GlaxoSmithKline (GSK) to clinically evaluate the combination of VBI-1901, VBI’s cancer vaccine immunotherapeutic, with GSK’s proprietary AS01B adjuvant system.
12 Sep 2019
Clinical Trials
Human Trials
Roche’s Tecentriq monotherapy significantly improves OS in phase III lung cancer study

By PBR Staff Writer

Roche announced that its lung cancer drug Tecentriq (atezolizumab) has significantly improved overall survival (OS) rate in the phase III IMpower110 study.

Drug Discovery

Research & Development

Ironwood Pharmaceuticals and AstraZeneca amend LINZESS (linaclotide) collaboration in China

Accenture announces collaboration with Bayer to streamline drug development processes through INTIENT clinical platform

Clinical Trials

Patient Enrollment

Impel NeuroPharma enrolls last patient in phase 3 migraine trial of INP104

Kedrion Biopharma announces enrollment of first patient in CARES10 trial

Regulation

Drug Filing

AstraZeneca’s Farxiga gets FDA fast track status in heart failure

FDA’s APAC panel votes in favour of Aimmune’s peanut allergy candidate

Production & Sales

Manufacturing

Pfizer to invest £411m in new US gene therapy manufacturing facility

Kite to bolster cell therapy manufacturing capabilities with new viral vector facility

Packaging & Supply Chain

Packaging

Gerresheimer

PCI Pharma announces bottling line expansion at Rockford site

Suppliers

No data found

Human Trials

Graybug Vision initiates clinical trial in macular edema secondary to diabetic macular edema or retinal vein occlusion

Novartis’ Cosentyx meets primary endpoint at Week 16 in PREVENT trial

Concert Pharmaceuticals completes enrollment in second open label trial of CTP-543 in alopecia areata

Poxel initiates phase 1b multiple ascending dose trial for NASH drug candidate

Alnylam initiates APOLLO-B phase 3 study of patisiran for treatment of transthyretin amyloidosis with cardiomyopathy

Arrowhead presents initial top-line clinical data and preclinical data on RNAi candidates ARO-APOC3 and ARO-ANG3

Novartis’ RMS drug ofatumumab achieves primary endpoints in phase III studies

Celgene’s QUAZAR AML-001 trial of CC-486 meets primary and key secondary endpoints

VBI Vaccines announces phase 2a trial of VBI-1901 plus AS01B adjuvant system in recurrent glioblastoma

Roche’s Tecentriq monotherapy significantly improves OS in phase III lung cancer study

Pharmaceutical Business review is using cookies

Research & Development

Patient Enrollment

Drug Filing

Manufacturing

Packaging

No data found