BioSpace News Archive

Policy

QIAGEN Releases QIAstat-Dx Test Kit to the U.S. as First Syndromic Test for Detection of SARS-CoV-2 Coronavirus Under New FDA Policy

QIAGEN announced that it has begun shipments to the United States of its new QIAstat-Dx Respiratory SARS-CoV-2 Panel test to aid in diagnosing patients infected with the novel COVID-19 coronavirus under a new Policy of the U.S. Food and Drug Administration announced on March 16. QIAGEN will submit this week the related Emergency Use Authorization to the FDA.

March 24, 2020
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2 min read
Business

Cognoa Appoints Industry Leader David Happel as New Chief Executive OfficerHappel takes up the top job at Cognoa after over 25 years of successfully commercializing medical products and as a leader in the biotech and biopharma industries

Cognoa, the leading digital therapeutics company focused on pediatric behavioral health, announced the appointment of David Happel as Chief Executive Officer.

March 24, 2020
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3 min read
Drug Development

OncoQuest Announces Publication of Two Reports Related to Oregovomab Phase 2 Clinical Trial, the Company’s Lead Investigational Drug in Frontline Ovarian Cancer

OncoQuest Inc. announced the publication of two reports relating to the recently completed Phase 2 trial conducted in the US and Italy utilizing oregovomab, the Company’s lead investigational drug in frontline ovarian cancer.

March 24, 2020
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6 min read
BioMidwest

Ampio is Preparing an Expanded Access FDA protocol to Study Nebulized Ampion as a Treatment for Moderate to Severe Acute Respiratory Distress Syndrome Associated with COVID-19

Ampio Pharmaceuticals, Inc. announced that it is preparing an expanded access FDA protocol to study potential benefit of nebulized treatment with Ampion in SARS-Cov-2 induced Acute Respiratory Distress Syndrome, an immediately life-threatening condition.

March 24, 2020
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5 min read
FDA

U.S. FDA Approves Supplemental New Drug Application (sNDA) for Expanded Indication of EUCRISA® (Crisaborole) Ointment, 2%, in Children as Young as 3 Months of Age With Mild-to-Moderate Atopic Dermatitis

EUCRISA is the first and only 100% steroid-free, topical prescription medication approved for patients as young as 3 months of age in the United States

March 24, 2020
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9 min read
Microbix Announces Quality Products Distribution AgreementAppointment of Medical Supply Company of Ireland

Microbix Biosystems Inc. announces the appointment of The Medical Supply Company of Ireland as a distributor.

March 24, 2020
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5 min read
Policy

Origin files patent application to protect its proposed treatment for viral and bacterial respiratory infections

Origin, Inc. announced that it has filed a provisional U.S. patent application to enhance the ability of its plasma-generated nitric oxide antimicrobial and antiviral therapy to be used to treat infections in the respiratory tract and other enclosed spaces in the body.

March 24, 2020
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3 min read
Policy

Helius Medical Technologies Announces Authorization from Health Canada to Market the PoNS™ Device for the Treatment of Gait Deficit Due to Mild and Moderate Multiple Sclerosis (MS)

Helius Medical Technologies, Inc., announced that its Canadian Class II license amendment application for the treatment of gait deficit in patients with mild and moderate symptoms from multiple sclerosis has received marketing authorization from Health Canada.

March 24, 2020
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4 min read
Biotech Beach

NCCN Guidelines Designate Decipher Prostate as “Recommended” for Men with Adverse Pathology after Radical Prostatectomy

The first and only genomic test to achieve “Recommended” status for the management of prostate cancer patients

March 24, 2020
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4 min read
Policy

Applied DNA Files Provisional Patent Application for High Sensitivity COVID-19 Diagnostic Assay with U.S. Patent and Trademark Office

Applied DNA Sciences Inc. announced the filing of a provisional patent application with the United States Patent and Trademark Office for its diagnostic assay under development for SARS-CoV-2, the virus that causes the disease COVID-19.

March 24, 2020
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4 min read