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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
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Policy
60° Pharma Submits NDA to U.S. FDA for Antimalarial Drug Tafenoquine
60 Degrees Pharma as submitted a NDA to the FDA for the use of Tafenoquine to prevent malaria in adults traveling to areas where malaria is prevalent.
December 18, 2017
·
4 min read
Drug Development
Galera Therapeutics Reports Statistically Significant Results in a 223-Patient Phase 2b Trial of GC4419 for Severe Oral Mucositis in Patients with Head and Neck Cancer
In the pre-specified secondary endpoints, GC4419 demonstrated a consistent effect across all efficacy measures.
December 18, 2017
·
4 min read
Drug Development
SciFluor Announces Positive Top-Line Results of Phase I/II Study of SF0166 Eye Drops to Treat Wet Age-Related Macular Degeneration
SciFluor announced positive top-line results of a Phase 1/2 trial studying the treatment of ‘wet’ age-related macular degeneration (AMD) patients with SF0166, the company’s lead eye drop drug for back of the eye diseases.
December 18, 2017
·
6 min read
Pharm Country
Feinstein Institute Grant Funds Fertility Decision Tool for Women Cancer Patients
Feinstein Institute for Medical Research Assistant Professor Catherine Benedict, PhD, has been awarded a two-year, $165,000 grant from the NIH to understand how young women who completed cancer treatment make fertility decisions and plan for future family-building.
December 18, 2017
·
4 min read
Policy
Repros Receives Feedback Following an Oral Explanation With the EMA
Repros today announced that following an Oral Explanation, it has received feedback that a negative opinion is likely to be received in January 2018 from the CHMP for the centralized MAA for enclomiphene for the treatment of secondary hypogonadism previously submitted to the EMA by the Company’s U.K. subsidiary, Renable Pharma Limited.
December 18, 2017
·
4 min read
Business
Zosano Announces Resignation of Bruce Steel from Board of Directors
Following up on Mr. Steel’s resignation, the number of Board of Director seats has been reduced to five.
December 18, 2017
·
3 min read
Drug Development
Achillion Announces ACH-4471 Granted Orphan Drug Designation for the Treatment of C3 Glomerulopathy (C3G) and the Initiation of a Phase 1 Extended-Release Bioavailability Study
This designation may provide, under specified conditions, for a seven-year marketing exclusivity period, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees.
December 18, 2017
·
6 min read
Genetown
Deciphera Pharma Added to Russell 2000 Index
Deciphera Pharma today announced that it has been added to the Russell 2000® Index, as part of Russell’s quarterly IPO additions, effective Friday, December 15, 2017, after market close.
December 18, 2017
·
1 min read
Business
Regeneron, ISA Pharma Ink Strategic Immuno-Oncology Collaboration
Regeneron and ISA Pharma today announced a clinical collaboration to advance ISA101 in combination with cemiplimaba, a PD-1 antibody.
December 18, 2017
·
10 min read
Biotech Beach
ACEA Release: Real-Time Monitoring of Melanoma Cell Invasion Helps Scientists Elucidate Key Regulators of Metastasis
A team of Italian scientists reported this week that blocking the interaction between urokinase receptor (uPAR) and formyl peptide receptor type 1 (FPR1) suppresses the ability of melanoma cells to migrate, invade through an extracellular matrix, and to burrow through a layer of endothelial cells.
December 18, 2017
·
3 min read
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