BioSpace News Archive

FDA

MeiraGTx Announces AAV-RPGR Granted Fast Track Designation by U.S. FDA for Treatment of X-Linked Retinitis Pigmentosa Due to RPGR Deficiency

MeiraGTx Limited, a vertically integrated, clinical stage gene therapy company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for AAV-RPGR for the treatment of X-linked retinitis pigmentosa (XLRP) due to defects in the retinitis pigmentosa GTPase regulator (RPGR) gene.

April 23, 2018
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3 min read
FDA

Surmodics Announces FDA Clearance of a New .018” Low-Profile PTA Balloon Dilation Catheter

Continued progress in R&D whole-product solutions pipeline

April 23, 2018
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4 min read
Biotech Beach

PMDAlliance and ACADIA Pharmaceuticals Survey Reveals Serious Quality-of-Life Impact of Non-Movement Symptoms of Parkinson’s Disease

Results underscore need for greater awareness of non-movement symptoms this Parkinson’s Disease Awareness Month

April 23, 2018
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6 min read
Pharm Country

Ipsen Announces Efficacy and Safety Data for Dysport® (abobotulinumtoxinA) Across Multiple Therapeutic Uses at the 2018 Annual Meeting of the American Academy of Neurology

Analyses of Pooled Data of Dysport® for the Treatment of Pediatric Lower Limb Spasticity Indicate a Consistent Safety Profile

April 23, 2018
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20 min read
Business

Kaleido Biosciences Announces Appointment of Joshua Brumm as Chief Financial Officer

Kaleido Biosciences, a clinical-stage biotechnology company developing novel chemistries to unlock the power of the human microbiome, today announced the appointment of Joshua Brumm as chief financial officer.

April 23, 2018
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3 min read
Policy

Akorn Asks Delaware Court to Require Fresenius Kabi to Fulfill Its Obligations under Merger Agreement

Akorn, Inc. (NASDAQ:AKRX), today filed a complaint in Delaware Chancery Court asking that Fresenius Kabi AG be required to fulfill its obligations under the definitive merger agreement, and issued the following statement:

April 23, 2018
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4 min read
Business

Acurian and Synexus Launch NASH Patient Enrollment Solution

New offering introduced at second annual NASH Summit

April 23, 2018
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4 min read
Business

Canon BioMedical Signs Exclusive Agreement to Distribute NEXTGENPCR Products

Canon BioMedical signs distribution agreement for the US and Canadian markets with Molecular Biology Systems

April 23, 2018
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2 min read