BioSpace News Archive

Drug Development

Therapeutic Solutions International Announces Initiation of JadiCell™ Manufacturing Program to Address Upcoming FDA Phase III Trial and Emergency Use Requests

Therapeutic Solutions International, Inc., (OTC Markets: TSOI) announced today initiation of pilot batch production of JadiCells, its umbilical cord stem cell product cleared by the FDA to enter Phase III clinical trials for COVID-19.

October 11, 2021
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2 min read
Genetown

Quanterix Granted Breakthrough Device Designation from U.S. FDA for Blood-Based pTau-181 Assay for Alzheimer’s Disease

Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis with the goal of advancing the science of precision health, announced today that its Simoa® phospho-Tau 181 (pTau-181) blood test has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA) as an aid in diagnostic evaluation of Alzheimer’s Disease (AD).

October 11, 2021
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3 min read
Deals

Rejuveron leads EUR 15.7 million Series B investment in Rejuvenate Biomed to accelerate clinical development of its sarcopenia treatment for healthy aging

Rejuveron Life Sciences AG today announced that it will ultimately acquire a majority shareholding in Rejuvenate Biomed NV.

October 11, 2021
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4 min read
BioForest

Parse Biosciences Extends RNA-Seq Kit Reach to Australia and New Zealand through Decode Sciences Agreement

Parse Biosciences today announced a partnership with Decode Science to provide Parse’s single-cell RNA-seq solution to the Australian and New Zealand markets.

October 11, 2021
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3 min read
Drug Development

Ascletis Announces Results of the Phase IIa trial of ASC22 (Envafolimab) in Patients with Chronic Hepatitis B to be Presented in Oral Parallel Session at The Liver Meeting® 2021 by American Association for the Study of Liver Diseases

Ascletis Pharma Inc. (HKEX: 1672) announces today that the results of Phase IIa trial of subcutaneously administered PD-L1 antibody ASC22 (Envafolimab) in patients with chronic hepatitis B (CHB) will be presented in oral parallel session at The Liver Meeting® 2021 by American Association for the Study of Liver Diseases (AASLD).

October 11, 2021
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3 min read
Biotech Bay

Koya Medical Presents Positive Interim Data from Randomized Trial Comparing its Dayspring Lymphedema Treatment to Pneumatic Compression

Koya Medical recently presented data from the company’s prospective, multi-center, randomized, crossover study (NILE – NCT04908254) comparing Dayspring®, the company’s active compression treatment for lymphedema, to a traditional pneumatic compression pump.

October 11, 2021
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5 min read
Business

Horizon Therapeutics plc to Release Third-Quarter 2021 Financial Results and Host Webcast on Nov. 3, 2021

Horizon Therapeutics plc (Nasdaq: HZNP) announced today that its third-quarter 2021 financial results will be released on Wednesday, Nov. 3, 2021.

October 11, 2021
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1 min read
Business

Kiromic BioPharma Announces Strategic Collaboration with Gemelli Teaching Hospital to Accelerate the Analysis of Allogeneic CAR-T Clinical Trial Candidate Alexis ISO-1 in Solid Cancers

Kiromic BioPharma, Inc. announces it has engaged in a strategic collaboration with Gemelli Teaching Hospital IRCCS to accelerate the analysis of the Company’s first allogeneic CAR-T clinical trial candidate Alexis ISO-1.

October 11, 2021
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6 min read
Revance Announces the Launch of OPUL™, the First-of-its-Kind Relational Commerce Platform for Aesthetic Practices

Revance Announces the Launch of OPUL ™ , the First-of-its-Kind Relational Commerce Platform for Aesthetic Practices

October 11, 2021
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8 min read
Mapi Pharma to Present Series of Recent Advancements for Treating Multiple Sclerosis (MS) at ECTRIMS 2021

Results for Glatiramer Acetate (GA) Depot Phase IIa study in patients with primary progressive multiple sclerosis, and novel anti-BMP for remyelination treatment in MS will be presented ECTRIMS 2021 Digital Experience will be held virtually Oct. 13-15, 2021

October 11, 2021
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4 min read