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BioSpace News Archive
Browse BioSpace’s published news and press releases by year, month, and day.
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BioCapital
Cerecor Announces FDA Acceptance of Investigational New Drug Application for CERC-803 to Treat Leukocyte Adhesion Deficiency Type II
Cerecor Inc. (NASDAQ: CERC), a biopharmaceutical company focused on becoming a leader in development and commercialization of treatments for rare and orphan diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug Application (IND) to study the use of CERC-803 to treat Leukocyte Adhesion Deficiency Type II (LAD II). The company plans to initiate a pivotal trial of
December 1, 2020
·
4 min read
Drug Development
BioCardia Reports Published Study Showing Helix Biotherapeutic Delivery System Used in CardiAMP Phase III Heart Failure Trial Has Fewest Adverse Events Among Competitive Delivery Systems
BioCardia®, Inc. [Nasdaq: BCDA] today announced that the Company’s proprietary Helix Biotherapeutic Delivery System (the Helix System) demonstrated the best safety profile among clinical transendocardial catheter injection systems used for cardiac cell therapy delivery in an in-press corrected proof published in the journal, Cardiovascular Revascularization Medicine
December 1, 2020
·
4 min read
Pharm Country
TG Therapeutics Initiates Rolling Submission of Biologics License Application to U.S. Food and Drug Administration for Ublituximab in Combination with Umbralisib as a Treatment for Patients with Chronic Lymphocytic Leukemia
Completion of rolling submission for the BLA expected in 1H2 1 NDA for u mbralisib monotherapy currently under review with the FDA ; PDUFA goal date of February 15, 2021 for MZL and June 15, 2021 for FL
December 1, 2020
·
8 min read
Policy
AMI Expeditionary Healthcare (AMI) Contracted by CDC to Study Spread of COVID-19 on University of Wisconsin Campuses
AMI Expeditionary Healthcare is contracted by Centers for Disease Control and Prevention to determine the prevalence of asymptomatic COVID-19 carriers on college campuses and what can be done to slow the spread of the disease.
December 1, 2020
·
1 min read
Business
CarepathRx and UPMC Announce Landmark Partnership to Bring Comprehensive Pharmacy Care Solutions to More Patients
CarepathRx, a leader in pharmacy and medication management solutions for vulnerable and chronically ill patients, announced a partnership with UPMC’s Chartwell subsidiary that will expand patient access to innovative specialty pharmacy and home infusion services.
December 1, 2020
·
5 min read
Business
CollPlant Biotechnologies Reports Third Quarter (Q3) 2020 Financial Results and Provides Business Update
- Expanded collaboration agreement with United Therapeutics which exercised its option for 3D bioprinted kidney transplants and $3 million payment to CollPlant - Increased revenues from 3D Bioprinting and Medical Aesthetics Business Collaborations
December 1, 2020
·
16 min read
Deals
Karyopharm Expands Board of Directors and Executive Leadership Team and Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
Stephen Mitchener Named Chief Business Officer, Bringing More than 17 Years of Partnering and Corporate Development Experience
December 1, 2020
·
12 min read
Business
Actinium Appoints Mary Mei Chen, M.D., Ph.D. as Vice President of Clinical Development
Dr. Chen brings over twenty years of clinical research and development experience; including executing global registrational trials in relapsed and refractory AML
December 1, 2020
·
8 min read
Biotech Bay
Tallac Therapeutics Launches with $62 Million in Series A Financing to Advance Novel Immunotherapies for Cancer
Tallac Therapeutics, Inc., a privately held biopharmaceutical company harnessing the power of innate and adaptive immunity to fight cancer, today announced the completion of its Series A financing totaling $62 million.
December 1, 2020
·
3 min read
BioMidwest
Carnegie Mellon University’s Delphi Research Group Enhances COVIDcast With Change Healthcare COVID-19 De-Identified Claims Data
Change Healthcare and Carnegie Mellon University’s Delphi Research Group announced the launch of Delphi’s enhanced COVIDcast real-time COVID-19 indicators.
December 1, 2020
·
4 min read
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