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Clinical Intelligence

FDA approves Topamax for migraine prevention in adolescents

Monday, March 31, 2014 12:55 PM

The FDA has approved Topamax (topiramate) for prevention (prophylaxis) of migraine headaches in adolescents ages 12 to 17. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a dailybasis to reduce the frequency of migraine headaches.

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FDA approves Otezla to treat psoriatic arthritis

Friday, March 28, 2014 12:50 PM

The FDA has approved Otezla (apremilast) to treat adults with active psoriatic arthritis (PsA).

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Mast Therapeutics initiates phase II study of MST-188 for acute limb ischemia

Friday, March 28, 2014 12:48 PM

Mast Therapeutics has initiated a phase II, clinical proof-of-concept study of MST-188 in combination with recombinant tissue plasminogen activator (rt-PA) in patients with acute lower limb ischemia.

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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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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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April 14

Proposal calls for back-to-back trials to measure efficacy and effectiveness prior to FDA approval

Study: Minority populations under-represented in cancer trials, but have higher rates of incidence

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Make way for mobile health in clinical trials
Despite patient retention, data quality benefits, regulatory hurdles persist

Global clinical trial laboratories decentralize
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Strategic alliances hit bumps in the road
Mixed relationship performance driving new approaches

Tapping community hospitals for clinical trial volunteers
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