Clinical Intelligence

Avanir Pharmaceuticals receives NDA acceptance for AVP-825 for migraines

Friday, March 28, 2014 12:42 PM

Avanir Pharmaceuticals, a biopharmaceutical company focused on central nervous system disorders, has announced that the FDA has accepted the company's New Drug Application (NDA) of AVP-825, its innovative Breath Powered investigational drug-device combination product for the acute treatment of migraine.

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WIRB Copernicus Group

Agios enrolls first patient in phase I study of AG-120

Friday, March 21, 2014 09:49 AM

Agios Pharmaceuticals, a company focused on discovering and developing novel drugs to treat cancer and inborn errors of metabolism (IEMs), has announced that the first patient has been dosed in a phase I study of AG-120 in patients with advanced hematologic malignancies with an isocitrate dehydrogenase-1 (IDH1) mutation. AG-120 is an orally available, selective, potent inhibitor of the mutated IDH1 protein, making it the first targeted therapeutic candidate to treat patients with cancers that harbor the IDH1 mutation.

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Novo Nordisk releases positive results in N8-GP trial

Thursday, March 20, 2014 03:22 PM

Novo Nordisk has completed pathfinder2, the first phase III trial with long-acting recombinant factor VIII, N8-GP (turoctocog alfa pegol) for hemophilia A patients. Pathfinder2 is a multi-national trial evaluating safety and efficacy of N8-GP, when administered for prophylaxis and on-demand treatment  in patients with hemophilia A, who are 12 years or older. 

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FDA approves Impavido to treat tropical disease leishmaniasis

Thursday, March 20, 2014 11:40 AM

The FDA has approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Leishmaniasis is a disease caused by Leishmania, a parasite which is transmitted to humans through sand fly bites. The disease occurs primarily in people who live in the tropics and subtropics. Most U.S. patients acquire leishmaniasis overseas.

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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.

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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.

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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.

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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.

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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.

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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).

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