Quest Diagnostics

Clinical Intelligence

Vyvanse is FDA-approved for moderate to severe binge eating disorder

Thursday, February 5, 2015 01:29 PM

The FDA has approved Shire’s Vyvanse (lisdexamfetamine dimesylate) Capsules (CII), the first and only medication for the treatment of moderate to severe binge eating disorder (BED) in adults, shown to significantly reduce the mean number of binge days per week. Vyvanse is not indicated or recommended for weight loss or the treatment of obesity. Other sympathomimetic drugs used for weight loss have been associated with serious cardiovascular reactions.

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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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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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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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The CenterWatch Monthly

May

Job satisfaction mixed as workload increases
Salaries not keeping pace with rise in work, responsibilities

Gamification moving from early science to patient use
Pharma looking to use games for early diagnosis, recruitment, adherence

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