BioSpace News Archive

Drug Development

Levo’s Prader-Willi Drug Strikes Out on Efficacy with FDA

The agency recommended another clinical trial be conducted to confirm the data from the study on the 3.2-mg dose of the intranasal carbetocin for Prader-Willi syndrome.

January 18, 2022
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2 min read
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Mark Terry
Drug Development

Early Career Shift Serendipitous for Kinaset CEO Robert Clarke, Asthma Patients

The problem Kinaset is trying to solve is that over time, patients receiving asthma therapies – typically inhaled corticosteroids plus bronchodilators – become steroid-refractory.

January 18, 2022
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4 min read
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Gail Dutton
Drug Development

FDA Needs More Time to Assess Bluebird Bio Gene Therapy BLAs

The extensions are due to the FDA’s requiring more time to review additional clinical data it had requested from bluebird.

January 18, 2022
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2 min read
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Mark Terry
Drug Development

Sensorion Hears Disappointing Results from Study of Key Asset

The company will continue to analyze data regarding the secondary endpoints.

January 18, 2022
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2 min read
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Hayley Shasteen
Drug Development

COVID-19 Update: Fourth Dose Value Questioned, CDC Promises Improved Messaging

Studies are ongoing in Israel on whether a fourth dose of an mRNA vaccine offers additional protection. Although the data is still early, it suggests that it might not.

January 18, 2022
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5 min read
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Mark Terry
Business

Antibody-Focused Amagma Shows Early Prowess with Innovent Pact

Amagma Therapeutics announced a licensing agreement with Innovent Biologics for up to three enzyme specific inhibitors derived from Amagma’s proprietary SEIZMIC Platform.

January 18, 2022
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2 min read
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Alex Keown
Venus Concept Receives FDA 510(k) Clearance of Venus BlissMAX for Non-Invasive Lipolysis of the Abdomen and Flanks, Cellulite Reduction and Muscle Conditioning

Venus Concept Inc. (“Venus Concept” or the “Company”) (NASDAQ: VERO), a global medical aesthetic technology leader, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market the Venus BlissMAX device (“BlissMAX”) in the United States.

January 18, 2022
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4 min read
Deals

Levitee Labs Announces Non-Brokered Private Placement of up to $3,000,000

Levitee Labs Inc. is pleased to announce that it is proposing to complete a non-brokered private placement (the “Private Placement”) of up to 15,000,000 units (the “Units”) at a price of $0.20 per Unit for aggregate gross proceeds of up to CAD$3,000,000.

January 18, 2022
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6 min read
Biotech Beach

Global Coalition for Adaptive Research Announces Key Updates on GBM AGILE Phase 2-3 Adaptive Platform Trial for Patients With Glioblastoma

Global Coalition for Adaptive Research (GCAR) today announced an update on the progress of GBM AGILE (Glioblastoma Adaptive Global Innovative Learning Environment - NCT03970447).

January 18, 2022
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6 min read
Business

Novo Integrated Sciences Reports First Quarter Financial Results

Novo Integrated Sciences, Inc. today reported its financial results for the fiscal quarter ended November 30, 2021.

January 18, 2022
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14 min read