Clinical Intelligence

Ebola vaccine trial opens in Liberia

Thursday, February 5, 2015 01:09 PM

A large clinical trial to assess the safety and efficacy of two experimental vaccines to prevent Ebola virus infection now is open to volunteers in Liberia. The trial is being led by a recently formed Liberia-U.S. clinical research partnership and is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The Partnership for Research on Ebola Vaccines in Liberia or PREVAIL, a phase II/III study, is designed to enroll approximately 27,000 healthy men and women aged 18 years and older.

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NIHR, Janssen partner on rheumatoid arthritis biological treatments

Thursday, February 5, 2015 12:50 PM

A new clinical research study has been launched that will explore why the current gold standard biological treatment for people with rheumatoid arthritis does not work in around a third of patients. The National Institute for Health Research (NIHR) study in partnership with Janssen will investigate key mechanisms associated with a lack of response to this treatment and its findings should open new routes for developing therapies for these patients.

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The CenterWatch Monthly, February 2015

Monday, February 2, 2015 08:00 AM

Study grants market breaks $13 billion

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Shire's SHP609 receives FDA Fast Track designation

Thursday, January 29, 2015 01:27 PM

The FDA has granted Fast Track designation for Shire’s SHP609 (idursulfase-IT; also known as HGT-2310) for the treatment of neurocognitive decline associated with Hunter syndrome (mucopolysaccharidosis II or MPSII).

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FDA approves Natpara for blood calcium levels related to hypoparathyroidism

Thursday, January 29, 2015 01:15 PM

The FDA has approved Natpara (parathyroid horomone) to control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism, a rare disease that affects approximately 60,000 people in the U.S.

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Genticel to continue per protocol its phase II study with ProCervix after review by DSMB

Thursday, January 29, 2015 10:54 AM

Genticel, a French biotechnology company and developer of therapeutic vaccines, has announced that the Data and Safety Monitoring Board (DSMB), an independent committee of experts which monitors safety data every six months during a study, met as scheduled on Jan. 22. It recommended the RHEIA-VAC study proceed without any modifications. The DSMB already had made the same recommendation during the first review on July 1, 2014.

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CytRx announces FDA's removal of partial clinical hold for aldoxorubicin trials

Thursday, January 22, 2015 02:41 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has announced that the FDA has removed the partial clinical hold on the company's aldoxorubicin clinical trials. Enrollment and dosing of new patients now is permitted after study sites' Institutional Review Boards (IRBs) approve the revised trial protocols.

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VolitionRx begins first ovarian cancer detection study

Thursday, January 22, 2015 02:39 PM

VolitionRx, a Belgium-based life sciences company focused on developing blood-based diagnostic tests for a broad range of cancer types and other conditions, has signed an agreement to commence a pilot ovarian cancer study in collaboration with Singapore General Hospital (SGH). Blood and tissue samples collected from 40 patients will be assessed to establish the feasibility of VolitionRx's proprietary NuQ assays in detecting ovarian cancer. If this test proves to be accurate, it could offer hope as an early-stage screening tool.

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Celator Pharmaceuticals receives FDA Fast Track for CPX-351 for AML

Thursday, January 22, 2015 01:54 PM

The FDA granted Fast Track designation for Celator Pharmaceuticals’ CPX-351 (cytarabine:daunorubicin) for the treatment of elderly patients with secondary acute myeloid leukemia (AML).

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TapImmune reports positive immune responses in phase I cancer trial

Friday, January 16, 2015 01:08 PM

TapImmune, an immunotherapy company, has reported the completion of data analysis from all 21 evaluable patients treated in a phase I clinical trial. In addition, the recent financing provides immediate, short term and long term access to the capital required to execute its exclusive option to license these very promising peptides and to progress its on-going clinical program into phase II trials.

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February 23

Venture capital investors funding novel drug R&D three times more than companies repurposing, improving existing drugs

In appreciation: Karen Woodin will be remembered for her teaching, writing and lasting friendships

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The CenterWatch Monthly

February

Study grants market breaks $13 billion
Volume of clinical activity rising while growth in grant spending slows

Revisiting eClinical Technology Solutions Adoption
While use of established solutions grows, sponsors hesitate on newer tools

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January

All eyes on EMA’s adaptive licensing pilot
Sponsors could offer innovative drugs to patients 8 years sooner

Ice Bucket Challenge a boon for ALS research
Donations soar, but phenomenon difficult to replicate

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