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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
66 Results
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Drug Development
Ionis and Akcea Present New Data from ATTR Amyloidosis Program at 16th International Symposium on Amyloidosis
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.
March 26, 2018
·
17 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
·
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
·
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
·
3 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
·
3 min read
Business
FORMA Therapeutics Collaborates with Arpeggio Biosciences to Explore Translational Utility of Drug Candidates
Arpeggio Biosciences will use its proprietary technology to identify immediate biological and genetic changes promoted by specific drug-target interactions
March 26, 2018
·
2 min read
Business
Emmaus Life Sciences Announces Opening of Office in New York to Support Endari Launch
Emmaus Life Sciences (Emmaus) announced today it has opened an office in Midtown Manhattan to support the commercial launch of EndariTM (L-glutamine oral powder).
March 26, 2018
·
3 min read
FDA
Bayer Announces Completion of Rolling Submission of New Drug Application in the U.S. for Larotrectinib for the Treatment of TRK Fusion Cancer
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.
March 26, 2018
·
3 min read
Drug Development
Allecra Therapeutics Announces Positive Top-Line Results from Phase 2 CACTUS Study of its Lead Candidate, AAI101, in Combination with Cefepime to Treat Complicated Urinary Tract Infections (cUTI)
Allecra Therapeutics announced positive top-line results from the Phase 2 study of its lead antibiotic candidate, an extended spectrum β-lactamase inhibitor known as AAI101.
March 26, 2018
·
6 min read
Drug Development
Protagonist Therapeutics Discontinues Phase 2b PROPEL Trial of PTG-100 for the Treatment of Ulcerative Colitis following Interim Analysis
Protagonist Therapeutics, Inc. announced that the Company is discontinuing the Phase 2b PROPEL study of PTG-100, its investigational oral GI-restricted alpha-4-beta-7 integrin antagonist peptide, in patients with moderate to severe ulcerative colitis (UC).
March 26, 2018
·
3 min read
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