Clinical Intelligence

FDA approves Imbruvica to treat chronic lymphocytic leukemia

Wednesday, February 12, 2014 02:30 PM

The FDA has expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.

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WIRB Copernicus Group

Aerie Pharmaceuticals initiates phase IIb study of PG324

Monday, February 3, 2014 11:16 AM

Aerie Pharmaceuticals, a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of first-in-class glaucoma therapies, has dosed the first patients enrolled in the company's phase IIb study of PG324, a novel, fixed-combination of Aerie's AR-13324 and latanoprost, a prostaglandin analogue that is the most widely prescribed glaucoma drug. The 28-day, phase IIb clinical trial is expected to enroll approximately 300 patients with glaucoma or ocular hypertension and will compare two concentrations of PG324 to latanoprost and to AR-13324, all dosed once daily. The efficacy endpoint will be superiority of PG324 to each of its components, as measured by the lowering of mean diurnal intraocular pressure (IOP) on day 28 compared to baseline. Topline results of this trial currently are expected in mid-2014.

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Avanir Pharmaceuticals submits NDA for AVP-825

Monday, February 3, 2014 11:01 AM

Avanir Pharmaceuticals, a biopharmaceutical company focused on central nervous system disorders of high unmet medical need, has submitted a NDA to the FDA for approval of AVP-825, its innovative Breath Powered investigational drug-device combination product for the acute treatment of migraine.

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FDA approves Hetlioz for sleep-wake disorder in blind individuals

Monday, February 3, 2014 10:38 AM

The FDA approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (non-24) in totally blind individuals. Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder.

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The CenterWatch Monthly, February 2014

Monday, February 3, 2014 08:59 AM

Tracking major changes in the R&D pipeline

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Omeros reports positive results from OMS824 phase IIa clinical trial

Friday, January 31, 2014 01:25 PM

Omeros has announced positive results from a phase IIa clinical trial of OMS824, the company's phosphodiesterase 10 (PDE10) inhibitor, in which the drug was well-tolerated and demonstrated comparable systemic pharmacokinetics when administered alone and concomitantly with approved antipsychotic agents in patients with schizophrenia. OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to a wide range of diseases that affect cognition, including schizophrenia and Huntington's disease.

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Singapore's influenza vaccines shows favorable immunogenicity, tolerability

Friday, January 31, 2014 01:20 PM

Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology have announced that their influenza vaccine (gH1-Qbeta) met its primary end point for immunogenicity (seroconversion based on haemaglutination inhibition titres according to FDA criteria) in the phase I clinical trial in healthy Asian volunteers. The induced immune response showed good cross-reactivity to recent drifted H1N1 strains. The H1N1 influenza vaccine candidate is based on Cytos' proprietary bacteriophage Qbeta virus-like particle (VLP) technology.

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MJFF highlights promising Parkinson’s research

Friday, January 31, 2014 01:03 PM

Research projects from three biopharmaceutical companies in the U.S. comprise the 2013 second half (2H 2013) of The Michael J. Fox Foundation for Parkinson's Research (MJFF) Partnering Program. Among the most promising in the MJFF portfolio, Partnering Program participants' research projects are presented directly to industry groups who may wish to invest in further development of the project. By connecting industry leaders with those studies ripe for investment, the foundation aims to drive forward promising research in Parkinson's disease (PD) through the pipeline of drug development and eventually into patients' hands.

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PTC Therapeutics, the SMA Foundation and Roche collaborate

Friday, January 24, 2014 10:39 AM

PTC Therapeutics, the SMA Foundation and Roche have announced that their joint research program in Spinal Muscular Atrophy (SMA) has entered the first stage of clinical development aiming to assess safety and tolerability of an oral compound in healthy volunteers. SMA is a genetic neuromuscular disorder that leads to muscle weakness and mobility impairment and is considered the leading genetic cause of death in infants and toddlers.

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BioLineRx receives Orphan Drug designation for stem cell mobilization treatment

Friday, January 24, 2014 10:34 AM

BioLineRx, a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, has received notice from the FDA confirming an Orphan Drug Designation of BL-8040 as a treatment for stem cell mobilization, in addition to the Orphan Drug Designation previously granted to BL-8040 as a treatment for Acute Myeloid Leukemia (AML).

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