Clinical Intelligence

Ocular Therapeutix begins enrollment in phase III trial for allergic conjunctivitis

Wednesday, June 17, 2015 10:41 AM

Ocular Therapeutix, a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, has enrolled its first patients in a phase III clinical trial to evaluate the safety and efficacy of Dextenza (sustained release dexamethasone, 0.4mg) for the treatment of allergic conjunctivitis. Dextenza is administered by a physician as a bioresorbable intracanalicular depot for drug release to the ocular surface for up 30 days.

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Akaal Pharma to initiate phase II trial for the topical treatment of psoriasis

Wednesday, June 17, 2015 07:50 AM

Akaal Pharma, a clinical-stage biopharmaceutical company, has received approval to initiate a randomized, double-blind, placebo-controlled phase-II clinical trial of its topical drug candidate AKP-11. AKP-11 is a novel First-in-Class topical Sphingosine 1-Phosphate receptor-1 (S1P1) modulator for the treatment of mild-to-moderate plaque psoriasis in patients. Patients will be treated daily for six weeks with the topical drug AKP-11.

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FDA grants Breakthrough designation for Actemra in Systemic Sclerosis

Thursday, June 11, 2015 12:59 PM

Genentech, a member of the Roche Group, has announced that the FDA has granted Breakthrough Therapy designation status to Actemra (tocilizumab) for systemic sclerosis, also known as scleroderma. This designation is intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases and to help ensure patients have access to them as soon as possible. Genentech also has initiated a phase III study in systemic sclerosis (NCT02453256), a disease for which there are inadequate treatment options.

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Arrowhead receives Orphan designation for liver disease treatment ARC-AAT

Thursday, June 11, 2015 12:57 PM

The FDA has granted Arrowhead Research’s ARC-AAT Orphan Drug designation. ARC-AAT is Arrowhead’s RNAi-based therapeutic candidate being investigated for the treatment of liver disease associated with Alpha-1 Antitrypsin Deficiency (AATD), a rare genetic disease that severely damages the liver and lungs of affected children and adults. Arrowhead currently is conducting part B of a phase I study of ARC-AAT in patients with PiZZ genotype AATD.

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FDA grants Orphan designation to Agios’ AG-120 for leukemia

Thursday, June 11, 2015 12:56 PM

The FDA has granted Agios Pharmaceuticals’ Orphan Drug designation for AG-120 for treatment of patients with acute myelogenous leukemia (AML). AG-120 is an oral, first-in-class IDH1 mutant inhibitor being evaluated in a phase I clinical trial in patients with advanced hematologic malignancies that carry an IDH1 mutation.

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bluebird bio completes NIH review, moved forward with trial against recommendation

Thursday, June 11, 2015 12:34 PM

bluebird bio, a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases and T cell-based immunotherapies, has completed the NIH Recombinant DNA Advisory Committee's (RAC) public review of the HGB-208 pediatric study protocol for bluebird bio's LentiGlobin BB305 product candidate in beta-thalassemia major. The RAC recommendation was to delay initiation of the study in the U.S. for one to two years. This recommendation has no effect on the HGB-207 protocol plan.

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Retrophin receives FDA Fast Track for pantothenate kinase-associated neurodegeneration

Friday, June 5, 2015 11:14 AM

The FDA has granted Fast Track designation for RE-024, the Retrophin’s novel investigational phosphopantothenate replacement therapy, for the treatment of pantothenate kinase-associated neurodegeneration (PKAN).

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FDA approves Cipla’s Lopinavir/ritonavir for AIDS in infants and young children

Thursday, June 4, 2015 01:18 PM

Cipla, a global pharmaceutical company, has received FDA approval for Lopinavir/ritonavir (LPV/r) 40mg/10mg oral pellets for paediatric specific treatment for infants.

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Merck, Dynavax collaborate on immuno-oncology therapies

Thursday, June 4, 2015 01:02 PM

Merck & Co. and Dynavax Technologies have entered into two clinical trial collaboration agreements to investigate the potential synergistic effect of combining immunotherapies from both companies' pipelines: Merck's anti-PD-1 therapy, Keytruda (pembrolizumab), and its investigational anti-interleukin-10 (anti-IL-10) immunomodulator, MK-1966, with Dynavax's investigational toll-like receptor 9 (TLR9) agonist, SD-101.

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The CenterWatch Monthly, June 2015

Monday, June 1, 2015 08:00 AM

TransCelerate Biopharma turns three

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CWWeekly

July 6

FDA sued by advocacy groups seeking hepatitis C trials data

Google to test health-tracking wristband to collect clinical trial data

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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