BioSpace News Archive

Bayer announced that its collaboration partner Loxo Oncology, Inc., has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for larotrectinib for the treatment of adult and pediatric patients.

Flex Pharma Inc. announced positive topline data for FLX-787 from its exploratory Phase 2 trial in MS patients with frequent muscle cramps/spasms and spasticity.

Ionis Pharmaceuticals, Inc. and Akcea Therapeutics, Inc. announced Phase 3 data showing that inotersen-treated patients with hereditary ATTR (hATTR) amyloidosis who were treated for up to 27 months in the NEURO-TTR and open-label extension (OLE) studies continued to demonstrate sustained benefit in measures of quality of life and neuropathy.

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.

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).

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”.

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).

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).

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

Arpeggio Biosciences will use its proprietary technology to identify immediate biological and genetic changes promoted by specific drug-target interactions