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Clinical Intelligence

ReCor receives CE mark for ultrasound-based renal denervation system

Thursday, January 24, 2013 02:00 PM

ReCor Medical, a private venture-backed, early-stage company focused on ultrasound catheter technology, has received CE mark for its next-generation Paradise system, a minimally invasive 6Fr over-the-wire (OTW) ultrasound device for treating resistant high blood pressure.

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Tresiba and Ryzodeg receive marketing authorizations in Europe

Wednesday, January 23, 2013 11:54 AM

The European Commission has granted marketing authorizations for Novo Nordisk’s Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) for the treatment of diabetes in adults.

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Cancer Research U.K. and Astex’s CRT initiate AT13148 trial for cancer

Friday, January 18, 2013 03:18 PM

Cancer Research Technology (CRT), the commercial arm of Astex Pharmaceuticals, a pharmaceutical company focused on novel small molecule therapeutics, along with its collaborator Cancer Research U.K., has initiated a trial of an experimental drug shown to simultaneously block many enzymes that control cancer cell growth and death.

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GSK submits albiglutide BLA to FDA for T2D

Monday, January 14, 2013 02:20 PM

GlaxoSmithKline (GSK), a global research-based pharmaceutical and healthcare company, announced a regulatory submission to the FDA for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes. 

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Telik receives Orphan status for Telintra for myelodysplastic syndrome

Monday, January 14, 2013 09:42 AM

Telik, a clinical stage drug development company focused on developing small molecule drugs to treat cancer, was notified today that its product candidate, ezatiostat HCL (Telintra), has been granted Orphan Drug designation by the FDA for the treatment of myelodysplastic syndrome (MDS). 

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KaloBios initiates phase II study with KB001-A in cystic fibrosis

Friday, January 11, 2013 12:10 PM

KaloBios Pharmaceuticals, a biopharmaceutical company based in San Francisco, Calif., has initiated dosing in a randomized, double-blind, placebo-controlled phase II clinical trial of KB001-A, the company's anti-PcrV Humaneered, PEGylated monoclonal antibody fragment. The study will investigate the safety and efficacy of intravenously administered KB001-A as a treatment for chronic Pseudomonas aeruginosa (Pa) infection in cystic fibrosis patients.

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CoDa boasts positive results in phase IIb study of Nexagon in chronic venous leg ulcers

Thursday, January 10, 2013 08:00 AM

CoDa Therapeutics, a clinical stage biotechnology company, released positive results from a phase IIb clinical trial of Nexagon in patients with chronic venous leg ulcers, which supports advancing Nexagon into phase III registration trials.

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Kareus initiates phase I trial in Alzheimer's disease

Friday, January 4, 2013 02:51 PM

Kareus Therapeutics, a private biotechnology company focused on unmet treatment of age-related and chronic diseases, has initiated a phase I clinical study following the Investigational New Drug (IND) approval from the FDA for the development of KU-046, a first-in-class disease modifying new chemical entity discovered for the treatment of Alzheimer's disease using Kareus' proprietary bioenergetics and KARLECT platforms.

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Aeterna Zentaris granted SPA for phase III endometrial cancer trial

Friday, January 4, 2013 02:24 PM

The FDA has granted Aeterna Zentaris Special Protocol Assessment (SPA) for an upcoming phase III registration trial in endometrial cancer with its doxorubicin peptide conjugate, AEZS-108.

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FDA grants accelerated approval for Sirturo for multi-drug resistant TB

Wednesday, January 2, 2013 03:13 PM

The FDA has granted accelerated approval to Janssen Therapeutics’ Sirturo (bedaquiline) tablets for the treatment of pulmonary multi-drug resistant tuberculosis (MDR-TB) as part of combination therapy in adults. The accelerated approval is based on the surrogate endpoint of time to sputum culture conversion.

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April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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The CenterWatch Monthly

April

Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
Regional labs reducing complexity, delivering cost and time savings

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March

Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
New study finds high potential but infrastructure, resources are lacking

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