BioSpace News Archive

Drug Development

AFFiRiS Announces FDA Response to its pre-IND Submission for Phase 2 Trial with AFFITOPE(R) PD01 in Early Parkinson’s Disease Patients Study start in the US and Europe confirmed for H2 2020

AFFiRiS AG, a clinical-stage biopharmaceutical company developing novel disease-modifying specific active immunotherapies (SAITs) for patients with neurodegenerative diseases, today announced it had received feedback to its pre-Investigational New Drug (“IND”) submission to the U.S. Food and Drug Administration (“FDA”) regarding the planned Phase 2 clinical trial with AFFITOPE(R) PD01,

January 28, 2020
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4 min read
Biotech Beach

Advanced Sterilization Products Unveils the Fastest Biological Indicator for Hydrogen Peroxide Sterilization, Available Exclusively With the STERRAD VELOCITY® System

Advanced Sterilization Products announced today it has received 510 clearance from the U.S. Food and Drug Administration for a 15-minute time to result on the STERRAD VELOCITY® Biological Indicator /Process Challenge Device for use in STERRAD® Systems.* The 15-minute time to result is up to 38% faster than competition and offers the fastest way to provide instrument sterility assurance for healthcare professionals.

January 28, 2020
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3 min read
Biotech Bay

Multiple Health Systems Help Optimize Efficiency and Patient Safety by Adopting Omnicell’s Point of Care Automated Workflow Technology

Smart medication management – using automation and data intelligence – is transforming patient care in hospitals across the U.S.

January 28, 2020
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3 min read
Drug Development

Cassava Sciences Announces Completion of Patient Enrollment of a Phase 2b Study in Alzheimer’s DiseaseTop-Line Results Expected Mid-year 2020

Cassava Sciences, Inc., a clinical-stage biotechnology company focused on Alzheimer’s disease, announced it has initiated dosing for the last patient in a Phase 2b study of PTI-125.

January 28, 2020
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5 min read
Policy

Aphios Granted US Patent For Combination HIV Latency Nanotherapeutic Towards an HIV Cure

Aphios Corporation announced that it was issued US Patent No. 10,493,030 for the treatment of HIV latency towards an HIV cure.

January 28, 2020
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3 min read
Policy

FDA Continues Strong Support of Innovation in Development of Gene Therapy Products

This is a pivotal time in the field of gene therapy as the FDA continues its efforts to support innovators developing new medical products for Americans and others around the world.

January 28, 2020
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6 min read
Business

Sun BioPharma, Inc. Initiates Search for CEOCompany founder Dr. Michael T. Cullen intends to continue to serve as Executive Chairman and will continue to serve as President and CEO until a successor is named

Sun BioPharma, Inc., a clinical-stage biopharmaceutical company developing disruptive therapeutics for the treatment of people with pancreatic cancer, announced the initiation of a search for a Chief Executive Officer to succeed Dr. Michael T. Cullen, MD, MBA.

January 28, 2020
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4 min read
Business

Heroic American Surgeon Dr. Tom Catena Earns Top Medical Missionary Award for Saving Lives in Africa’s Forgotten War Zone

Catena to receive annual prestigious AMH Gerson L’Chaim Prize for ‘outstanding Christian medical missionary service’ from African Mission Healthcare

January 28, 2020
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4 min read
Guided Therapeutics Plans Growth for 2020 After Closing Significant Financing

Guided Therapeutics, Inc., the maker of a rapid and painless cervical cancer detection test based on its patented biophotonic technology, announced the Company’s plans for 2020.

January 28, 2020
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4 min read
Drug Development

Syros Announces First Patient Dosed in Phase 1 Clinical Trial of SY-5609, Its Highly Selective and Potent Oral CDK7 Inhibitor, in Patients with Select Solid Tumors

Syros Pharmaceuticals, a leader in the development of medicines that control the expression of genes, announced that the first patient has been dosed in the Phase 1 clinical trial of SY-5609, its highly selective and potent oral cyclin-dependent kinase 7 inhibitor.

January 28, 2020
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6 min read