BioSpace News Archive

Biotech Bay

Medable Allies With MRN to Support New Remote Care Capabilities Globally, Critical for Decentralized Clinical Trials and Continued Clinical Research Progress During COVID-19

Medable Inc., the leading global platform for decentralized clinical trials, and MRN today announced a global alliance to bring shared capabilities to decentralized clinical trials.

April 6, 2020
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4 min read
Drug Development

Boston Biomedical, Inc. Announces First Patient Dosed in Phase 1 Study of Investigational Agent TP-3654 in Patients with Myelofibrosis

Boston Biomedical, Inc. today announced the first patient has been dosed in a phase 1 study evaluating the investigational agent TP-3654, a PIM kinase inhibitor, in patients with intermediate-2 and high-risk primary or secondary myelofibrosis.

April 6, 2020
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3 min read
BioCapital

Community Blood Centers Mobilize to Assist COVID-19 Patients

America’s Blood Centers and its members are working closely with the U.S. Food and Drug Administration to collect and distribute convalescent plasma from individuals who have recovered from COVID-19..

April 6, 2020
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2 min read
Policy

Patients and Behavioral Health Providers Sue Viant, Cigna and United for Conspiring to Underpay Out-of-Network Claims

The landmark suits allege the insurers used Viant to get around NY Attorney General’s 2015 settlement with United over illegal reimbursement practices.

April 6, 2020
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3 min read
Pharm Country

OraSure Technologies Receives BARDA Contract for Rapid Oral Fluid Pan-SARS-Coronavirus In-home Self-test

OraSure Technologies, Inc. announced it has been awarded a $710,310 contract from the Biomedical Advanced Research and Development Authority, part of the Department of Health and Human Services, to develop a pan-SARS-coronavirus antigen rapid in-home self-test that uses oral fluid samples.

April 6, 2020
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8 min read
Drug Development

Axsome Therapeutics Announces AXS-07 Achieves Both Co-Primary Endpoints and Prevents Migraine Pain Progression in the INTERCEPT Phase 3 Trial in the Early Treatment of Migraine

Achieved freedom from migraine pain in 33% of AXS-07 patients versus 16% for placebo at 2 hours (co-primary endpoint, p=0.002)

April 6, 2020
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15 min read
Deals

Genetic Technologies Announces Closing of $1.8 Million Registered Direct Offering

Genetic Technologies Limited announced the closing of the previously announced registered direct offering of 1,028,574 American Depositary Shares, each representing six hundred of the Company’s ordinary shares, at a purchase price of $1.75 per ADS.

April 6, 2020
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3 min read
Policy

Axonics® Submits PMA Supplement to U.S. Food & Drug Administration to Expand Full-Body MRI Labeling for 3T Scans

Axonics Modulation Technologies, Inc. announced the submission of a premarket approval supplement to the U.S. Food & Drug Administration for the purpose of gaining full-body magnetic resonance imaging conditional labeling for 3.0T MRI scans..

April 6, 2020
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3 min read
Policy

Mallinckrodt Initiates Rolling Submission of Biologics License Application for StrataGraft® Regenerative Skin Tissue to U.S. Food and Drug Administration

Application is Supported by Data from Pivotal Phase 3 Study for the Treatment of Deep Partial-Thickness Thermal Burns

April 6, 2020
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7 min read
Business

Global Plasma Leaders Collaborate to Accelerate Development of Potential COVID-19 Hyperimmune Therapy

Partnership brings together world-leading plasma companies to focus on developing and delivering a hyperimmune immunoglobulin in the global fight against COVID-19

April 6, 2020
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9 min read