Theorem Clinical Research

Clinical Intelligence

PhotoxAir reduces airborne bacteria in clinical trials

Thursday, October 9, 2014 11:54 AM

Wake Forest Baptist Medical Center, a North Carolina-based medical center, has announced that studies have conclusively demonstrated that the PhotoxAir purification system significantly reduced airborne bacteria in clinical trials conducted in an emergency department setting.

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Quest Diagnostics

Bristol-Myers Squibb withdraws NDA with FDA for asunaprevir

Thursday, October 9, 2014 11:51 AM

Given the rapidly evolving hepatitis C (HCV) treatment landscape in the U.S., Bristol-Myers Squibb has decided that it will not pursue FDA approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the U.S. and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor. The company will continue to pursue FDA approval of daclatasvir, a potent, pan-genotypic NS5A complex inhibitor (in vitro), which currently is being investigated globally in multiple treatment regimens for HCV patients with high unmet need.

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Chimerix receives Emergency Investigational NDA for Ebola

Thursday, October 9, 2014 11:45 AM

Chimerix, a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, has announced that brincidofovir has been provided for potential use in patients with Ebola virus disease. These requests were made by treating physicians. Emergency Investigational New Drug Applications (EIND) were granted by the FDA.

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Noven receives FDA new indication approval for Minivelle

Thursday, October 2, 2014 02:01 PM

Noven Pharmaceuticals has announced that the FDA has approved a new indication with a new dose of Minivelle (estradiol transdermal system) for the prevention of postmenopausal osteoporosis. The FDA initially approved Minivelle in October 2012 to treat moderate to severe vasomotor symptoms (VMS) due to menopause, commonly known as hot flashes. With this new approval, women who are using Minivelle to treat their VMS symptoms have the benefit of also helping to prevent osteoporosis.

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CytRx receives multiple FDA Orphan Drug designations for Aldoxorubicin

Thursday, October 2, 2014 01:50 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has announced that the FDA has granted multiple Orphan Drug designations for the company's lead drug candidate, aldoxorubicin, in three indications: glioblastoma multiforme (GBM), small cell lung cancer and ovarian cancer. Aldoxorubicin is CytRx's modified version of the widely-used chemotherapeutic agent, doxorubicin.

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Amgen reports positive results of two phase III studies of evolocumab

Thursday, October 2, 2014 12:46 PM

Amgen has announced data from two phase III studies, RUTHERFORD-2 and TESLA, that showed treatment with evolocumab, a novel investigational low-density lipoprotein cholesterol (LDL-C)-lowering medication, resulted in a statistically significant reduction in LDL-C compared to placebo in patients with different types of familial hypercholesterolemia (FH). FH is an inherited condition caused by a gene mutation, which leads to high levels of LDL-C, or "bad" cholesterol, and premature cardiovascular disease.

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The CenterWatch Monthly, October 2014

Wednesday, October 1, 2014 06:00 AM

CROs driving changes in patient recruitment

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Amgen submits BLA for investigational BiTE immunotherapy blinatumomab

Thursday, September 25, 2014 02:55 PM

Amgen has submitted a Biologics License Application (BLA) to the FDA seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab. The BLA is for the treatment of adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.

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Inovio expands HPV immunotherapy development to aerodigestive cancers

Thursday, September 25, 2014 02:51 PM

Inovio Pharmaceuticals has initiated a phase I clinical trial in patients with aerodigestive cancers. The trial will evaluate the safety, tolerability and immunogenicity of INO-3106. This immunotherapy targets human papillomavirus type 6 (HPV-6), which causes most aerodigestive cancers.

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Braeburn Pharmaceuticals' probuphine study hits enrollment milestone

Thursday, September 25, 2014 02:50 PM

Braeburn Pharmaceuticals has surpassed the midway point for patient enrollment in its phase III study of Probuphine, which began in July. Probuphine is a buprenorphine subdermal implant being studied for the maintenance treatment of opioid dependence. Completion of the study is on track for the middle of 2015, with submission of the New Drug Application to the FDA expected to follow later in the year.

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AiCure
CWWeekly

March 23

Industry welcomes FDA draft guidance outlining the use of electronic Informed Consent for trials

Apple launches ResearchKit platform to tap millions of iPhone users to enroll in observational studies using apps

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The CenterWatch Monthly

March

Novo Nordisk, Takeda, Servier, Celgene among top sponsors
New gains seen from patient- and site-centric initiatives

Patient reported outcomes take center stage
FDA combining PROs, clinical outcomes in its approval decisions

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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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