Clinical Intelligence

Novartis publishes CTL019 data for acute lymphoblastic leukemia

Thursday, October 16, 2014 11:55 AM

Novartis and the University of Pennsylvania's Perelman School of Medicine have announced preliminary results from two pilot clinical trials published in The New England Journal of Medicine (NEJM) evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL). The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor (CAR) therapy CTL019.

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FDA approves Ofev to treat idiopathic pulmonary fibrosis

Thursday, October 16, 2014 11:49 AM

The FDA has approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

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University of Maryland, Malian Ministry begin human trials of Ebola vaccine in West Africa

Monday, October 13, 2014 09:16 AM

The Center for Vaccine Development (CVD), in conjunction with its sister institution, the Center for Vaccine Development of Mali (CVD-Mali) and the Ministry of Health of Mali, have begun a clinical trial in health care workers (and other front-line workers) to evaluate a promising experimental Ebola vaccine.

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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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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dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the U.S. and has therefore withdrawn its new drug application (NDA) for asunaprevir, an NS3/4A protease inhibitor.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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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

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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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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