AiCure

Clinical Intelligence

Omeros reports positive data for OMS721 for thrombotic microangiopathy

Thursday, November 20, 2014 01:29 PM

Omeros has announced positive data using OMS721, the lead human monoclonal antibody for its mannan-binding lectin-associated serine protease-2 (MASP-2) program, to inhibit thrombus formation in an ex vivo pathophysiologic system of human atypical hemolytic uremic syndrome (aHUS), a form of thrombotic microangiopathy (TMA).

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BerGenBio receives Orphan Drug designation from FDA for AML treatment

Thursday, November 20, 2014 01:25 PM

The FDA has granted Orphan Drug designation for BerGenBio’s BGB324 for treatment of acute myeloid leukaemia (AML).

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Spinal muscular atrophy program enters phase Ib/IIa trial in patients with SMA

Thursday, November 20, 2014 01:19 PM

PTC Therapeutics’ joint development program in spinal muscular atrophy (SMA) with Roche and the SMA Foundation (SMAF) has started a phase Ib/IIa study in adult and pediatric patients. The placebo-controlled, randomized, multiple-dose study will enroll approximately 48 patients with SMA and investigate the safety and tolerability of an investigational survival of motor neuron 2 (SMN2) gene splicing modifier (RG7800) over 12 weeks. The achievement of this milestone triggers a $10 million payment to PTC from Roche.

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FDA accepts Actavis’ sNDA for Saphris for bipolar I disorder in pediatric patients

Thursday, November 13, 2014 02:35 PM

The FDA has accepted for filing Actavis' supplemental New Drug Application (sNDA) for Saphris (asenapine) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients 10 to 17 years of age. Actavis' sNDA for Saphris has been granted priority review status by the FDA.

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Cell Source's Megadose Drug Combination to begin human trials in Italy

Thursday, November 13, 2014 02:31 PM

Cell Source, an immunotherapy and regenerative medicine company, has announced its Megadose Drug Combination has been cleared for human clinical trials in Italy. Cell Source's proprietary Megadose Drug Combination is expected to increase bone marrow transplantation (BMT) success and survival.

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FDA approves sNDAs for Invega Sustenna for schizoaffective disorder

Thursday, November 13, 2014 02:22 PM

The FDA has approved Janssen Pharmaceutical's supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy. The symptoms of schizoaffective disorder are complex and, without treatment, disabling. The FDA approved these sNDAs under Priority Review, which is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions.

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Spark Therapeutics receives FDA Breakthrough Therapy designation for SPK-RPE65

Friday, November 7, 2014 01:29 PM

Spark Therapeutics, a late-stage gene therapy company developing treatments for debilitating genetic diseases, has announced that its lead product candidate, SPK-RPE65, has received Breakthrough Therapy designation from the FDA. Breakthrough Therapy designation is intended to expedite the development and review of investigational therapies for serious or life-threatening conditions where initial clinical evidence demonstrates a significant improvement over existing therapies. SPK-RPE65 targets a group of blinding conditions known as inherited retinal dystrophies (IRDs) caused by autosomal recessive mutations in the RPE65 gene, and for which there currently is no pharmacologic treatment available.

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Leading BioSciences submits compassionate use IND for Ebola-related shock

Friday, November 7, 2014 01:03 PM

Leading BioSciences, a clinical-stage, platform pharmaceutical company focused on developing therapies and diagnostics to treat and halt multi-organ failure resulting from shock, has submitted an expanded access Investigational New Drug application (IND) with the FDA— also known as "compassionate use"—for its lead product LB1148.

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FDA issues response letter for Aeterna Zentaris' Macrilen NDA

Friday, November 7, 2014 12:58 PM

Aeterna Zentaris, is a specialty biopharmaceutical company, has received a complete response letter (CRL) from the FDA for its NDA for Macrilen (macimorelin), a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency (AGHD). Based on its review, the FDA has determined that the NDA cannot be approved in its present form.

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The CenterWatch Monthly, November 2014

Monday, November 3, 2014 08:12 AM

Private equity fueling CRO growth, expansion

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November 17

PPD, Medidata join their technologies for risk-based monitoring, adaptive trial design

ERT acquires eClinical Insights in "strategic combination" to gain cloud-based trial software platform, expertise

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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

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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

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