AiCure

Clinical Intelligence

FDA approves first ICD to be evaluated in clinical trials for use in MRIs

Friday, March 14, 2014 09:53 AM

Biotronik, a manufacturer of cardiovascular medical devices, has announced that the FDA has approved the expansion of Biotronik’s ongoing ProMRI trial. The new phase of the trial (phase C) will study the company’s ProMRI technology in implantable cardioverter-defibrillator (ICD) devices. Biotronik is the only company in the world with an ICD that is approved for investigational use in an MRI (magnetic resonance imaging) scanner. The ongoing ProMRI study is the first step in making this standalone technology available in the U.S.

More... »


Trophos’ olesoxime pivotal trial produces positive results

Friday, March 14, 2014 09:41 AM

Trophos, a clinical stage pharmaceutical company developing innovative therapeutics for indications with under-served needs in neurology and cardiology, has announced that top-line results from a pivotal clinical trial of its lead product candidate olesoxime in spinal muscular atrophy (SMA) show a beneficial effect on the maintenance of motor function in SMA patients. If approved, olesoxime could be the first treatment specifically developed for SMA patients.

More... »

Subscribe to The CenterWatch Monthly

Upsher-Smith receives FDA approval for Qudexy XR (topiramate)

Thursday, March 13, 2014 11:15 AM

Upsher-Smith Laboratories has received FDA approval for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic (PK) profile.  Qudexy XR is indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures.  It also is approved as adjunctive therapy in patients two years of age and older with POS, primary generalized tonic-clonic seizures and seizures associated with Lennox-Gastaut syndrome. Qudexy XR will be available to patients in the second quarter of 2014.

More... »

Merck’s investigational HIV therapy Doravirine demonstrates antiviral activity

Friday, March 7, 2014 10:01 AM

Merck has presented data from the dose-ranging portion of an ongoing phase IIb clinical trial of doravirine, the company’s investigational next-generation, non-nucleoside reverse transcriptase inhibitor (NNRTI). Interim data demonstrating potent antiretroviral (ARV) activity for four doses of once-daily, oral doravirine in combination with tenofovir/emtricitabine in treatment-naïve, HIV-1 infected adults after 24 weeks of treatment were presented during a late-breaker oral session. Based on these findings as well as other data from the doravirine clinical program, Merck plans to initiate a phase III clinical trial program for doravirine in combination with ARV therapy in the second half of 2014.

More... »

FDA approves AVEED injectable testosterone replacement therapy

Thursday, March 6, 2014 08:51 AM

Endo Pharmaceuticals, a global specialty healthcare company, has received FDA approval of AVEED (testosterone undecanoate) injection for the treatment of adult men with hypogonadism (commonly known as Low-T) that is associated with a deficiency or absence of the male hormone testosterone. AVEED is a new prescription medicine indicated to produce serum testosterone levels in the normal range by administration of a single 3-mL (750mg) intramuscular injection given once at initiation of therapy, at four weeks, and then every 10 weeks thereafter. It is expected to be available in early March.

More... »

MEI Pharma receives Orphan status for AML treatment Pracinostat

Monday, March 3, 2014 11:16 AM

MEI Pharma, a San Diego-based oncology company focused on the clinical development of novel therapies for cancer, has announced that the FDA has granted orphan drug designation to the company's investigational drug Pracinostat for the treatment of acute myeloid leukemia (AML).

More... »

The CenterWatch Monthly, March 2014

Monday, March 3, 2014 08:00 AM

Strategic alliances hit bumps in the road

More... »

Parkinson's Biomarker initiative expands study of genetics

Friday, February 28, 2014 11:47 AM

The Parkinson's Progression Markers Initiative (PPMI), a large-scale biomarker study sponsored by The Michael J. Fox Foundation for Parkinson's Research (MJFF), is expanding to study individuals with genetic mutations associated with Parkinson's disease (PD). Researchers hope that greater understanding of the biology and clinical features of these participants—people with or at risk to develop Parkinson's—will lead to therapeutics that would help all Parkinson's patients and ultimately provide strategies to prevent disease onset.

More... »

Sinovac's EV71 vaccine produces positive phase III clinical trial results

Friday, February 28, 2014 11:35 AM

Sinovac Biotech, a provider of biopharmaceutical products in China, has announced that Phase III clinical trial results for its proprietary Enterovirus 71 (EV71) vaccine have been published online in the February 27 issue of TheNew England Journal of Medicine (NEJM). The clinical results showed the efficacy of the vaccine against EV71-associated hand, foot and mouth disease (HFMD), or herpangina, was 94.8% among infants and young children and an anti-EV71 neutralizing antibody titer of 1:16 was associated with protection against EV71 associated HFMD or herpangina. As outlined in the NEJM article, Sinovac's vaccine also demonstrated a 100% efficacy rate against EV71-associated hospitalization and against HFMD with neurologic complications, the main cause of fatalities.

More... »

FDA approves Myalept to treat rare metabolic disease

Wednesday, February 26, 2014 11:42 AM

The FDA has approved Myalept (metreleptin for injection) as replacement therapy to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized or acquired generalized lipodystrophy. 

More... »


CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

November 24

Tufts CSDD’s $2.6 billion price tag to develop and bring a new drug to market raises questions, criticisms

Medidata joins GlaxoSmithKline in study to evaluate the impact of wearing mobile devices in clinical trials

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

November

Private equity driving dynamic CRO growth
Enables CROs to pursue long-term strategies, while giving the space credibility

Baby boomers poised to reshape clinical trials industry
Millions of tech-savvy consumers already track their health, expect new treatments as they age

Already a subscriber?
Log in to your digital subscription.

Purchase the September issue.

Subscribe to
The CenterWatch Monthly.

The CenterWatch Monthly

October

CROs driving changes in patient recruitment
Data- and tech-aided enrollment services a competitive advantage

Trials with in-home nurses poised to grow
Higher expense, but may improve recruitment and retention for select trials

Already a subscriber?
Log in to your digital subscription.

Purchase the October issue.

Subscribe to
The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs