BioSpace News Archive

Business

Kala Pharmaceuticals Reports Fourth Quarter and Full Year 2017 Financial Results

Kala Pharmaceuticals, Inc. reported financial results for the fourth quarter and full year 2017.

March 26, 2018
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9 min read
FDA

FDA 510(k) Clears ORTHO CONNECT™ Middleware Solution from Ortho Clinical Diagnostics

Offering ‘one connection, complete control’ through simplified data management, ORTHO CONNECT V2.0 is now commercially available in the United States

March 26, 2018
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3 min read
Drug Development

GT Biopharma, Inc. Announces Additional Positive Data From Its Phase 1 Clinical Trial For Myasthenia Gravis and Potential for Acceleration of the Start of Its Phase 2 Trial

GT Biopharma Inc. (OTCQB “GTBP” and Euronext Paris “GTBP.PA”) today announced that it has completed the analysis of pharmacokinetic data from its Phase 1 clinical trial for GTP-004, its promising treatment for the symptoms of myasthenia gravis.

March 26, 2018
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5 min read
FDA

Astellas and Seattle Genetics Receive FDA Breakthrough Therapy Designation for Enfortumab Vedotin in Locally Advanced or Metastatic Urothelial Cancer

Astellas Pharma Inc. and Seattle Genetics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI).

March 26, 2018
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4 min read
Policy

BioLife Solutions and SAVSU Technologies to be Awarded Second Patent for Next Generation Cold Chain Technologies Designed for Cell and Gene Therapies

BioLife Solutions Inc. and SAVSU Technologies announced that the USPTO has issued a notice of allowance for a second patent application titled “Biologic Stability, Delivery Logistics and Administration of Time and/or Temperature Sensitive Biologic Based Materials”.

March 26, 2018
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3 min read
FDA

DarioHealth Receives U.S. FDA Clearance for iPhone 7, 8 and iPhone X Smart Glucose Meter

DarioHealth Corp. announced that the United States Food and Drug Administration (FDA) has granted Pre-market Notification (510(k)) clearance for the Company’s Lightning®-enabled version of the acclaimed Dario™ Blood Glucose Monitoring System which enables the use of the Dario app on iPhone 7, 8 and X smart mobile devices (SMD).

March 26, 2018
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2 min read
MedPharm Receives Growth Equity Investment from Ampersand Capital Partners

MedPharm Ltd., a leading provider of contract topical and transdermal product design and formulation development services, is pleased to announce an investment by Ampersand Capital Partners.

March 26, 2018
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3 min read
Drug Development

Eiger Announces First Patient Dosed in Phase 2 PREVENT Study of Exendin 9-39 in Patients Suffering from Post-Bariatric Hypoglycemia

Eiger BioPharmaceuticals, Inc. announced the first patient dosed in PREVENT, a Phase 2, multi-center study of subcutaneous (SC) exendin 9-39 in post-bariatric surgical patients who experience dangerously low, postprandial blood glucose levels (hypoglycemia) known as post-bariatric hypoglycemia (PBH).

March 26, 2018
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6 min read
FDA

Palatin Technologies Announces Submission of Bremelanotide NDA to FDA for Treatment of Hypoactive Sexual Desire Disorder (HSDD) in Premenopausal Women

NDA includes data from two successful Phase 3 trials in HSDD in premenopausal women in which bremelanotide met the pre-specified co-primary efficacy endpoints

March 26, 2018
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7 min read
FDA

Bioness Receives FDA Clearance for myBioness™ iOS app for mobile control of the L300 Go™ System

The myBioness is the first mobile app designed to provide control of the L300 Go™ System.

March 26, 2018
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3 min read