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Biotherapeutic Product Articles & Analysis

27 news found

Bened Biomedical Completes $10M Series A, Set for Expansion into US Healthcare Market

Bened Biomedical Completes $10M Series A, Set for Expansion into US Healthcare Market

Medical probiotic leader Bened Biomedical Co., Ltd., which develops and markets neuroactive probiotic products, announced a completed Series A round of fundraising, receiving more than $10 million of capital from two prominent investors, Trans-Pacific Technology Fund (TPTF) and JAFCO Asia. With strategic support from these venture capital partners, Bened expects to ...

ByBened Biomedical Co., Ltd.


Suono Bio, Inc. Announces Exclusive Patent License with MIT for Portfolio of Granted IP Covering Formulation-Independent Drug Delivery

Suono Bio, Inc. Announces Exclusive Patent License with MIT for Portfolio of Granted IP Covering Formulation-Independent Drug Delivery

Suono Bio, Inc., the company revolutionizing the treatment of gastrointestinal diseases, today announced it has entered into an exclusive world-wide patent license with Massachusetts Institute of Technology (MIT), Brigham and Woman’s Hospital, and Massachusetts General Hospital. The associated patents broadly cover foundational elements for the rapid, targeted delivery of drugs, including ...

BySuono Bio


CD BioGlyco Released Characterization Service of Glycosylation in Protein Drugs

CD BioGlyco Released Characterization Service of Glycosylation in Protein Drugs

Glycoproteins, such as glycosyltransferases, glycosidases, erythropoietin, and cytokines, make up the majority of biotherapeutic products. Although the drugs themselves are complicated, it is urgent to develop techniques to characterize glycosylation in order to better evaluate their effects. ...

ByCD BioGlyco.


Vedanta Presents Data from Multiple Studies at Digestive Disease Week 2022 Annual Meeting

Vedanta Presents Data from Multiple Studies at Digestive Disease Week 2022 Annual Meeting

Title: Durable colonization of the rationally designed live biotherapeutic products VE202 and VE818 in healthy volunteers. Presenter: Emily Crossette, Ph.D. ...

ByVedanta Biosciences, Inc


Microviable announces 1.5 million € investment to advance the company´s microbiota-derived biotherapeutic products.

Microviable announces 1.5 million € investment to advance the company´s microbiota-derived biotherapeutic products.

The microbiota-derived product development platform also includes rationally design and defined bacterial consortia that will be advanced with this funding. ...

ByMicroviable Therapeutics SL


BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure

BioCardia Announces New Center for Medicare and Medicaid Services Reimbursement Code Applicable to the CardiAMP Cell Therapy Procedure

“This most recent action by CMS further represents its commitment to improving the way ischemic heart failure is treated and is supportive of BioCardia’s therapeutic investigational product candidates furnished by a comprehensive approach to bone marrow cell harvest, processing, and delivery in a single procedure,” commented Peter Altman, Ph.D., ...

ByBiocardia, Inc.


City of Hope and Osel Announce Live Biotherapeutic Product CBM588 May Enhance Efficacy of Immunotherapy for Patients With Metastatic Kidney Cancer

City of Hope and Osel Announce Live Biotherapeutic Product CBM588 May Enhance Efficacy of Immunotherapy for Patients With Metastatic Kidney Cancer

City of Hope, one of the largest cancer research and treatment organizations in the United States, and Osel Inc., a company developing live biotherapeutic products for modulation of the human microbiome, today announced Phase 1 trial data showing that use of the live biotherapeutic CBM588 (Clostridium butyricum MIYAIRI 588® strain) plus ...

ByOsel Inc.


BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed

BioCardia Announces Positive DSMB Review and Recommendation to Continue Phase III Pivotal CardiAMP Cell Therapy Heart Failure Study as Designed

CardiAMP™ autologous and NK1R+ allogeneic cell therapies are the Company’s biotherapeutic product candidates in clinical development. The Company's current products include the Helix™ transendocardial delivery system, the Morph® steerable guide and sheath catheter portfolio and the AVANCE™ steerable introducer family. ...

ByBiocardia, Inc.


Siolta Therapeutics Awarded NIH Grant

Siolta Therapeutics Awarded NIH Grant

The grant will provide funding for the continued development and optimization of manufacturing approaches for live biotherapeutic products containing strictly anaerobic, non-spore forming bacteria as active pharmaceutical ingredients. ...

BySiolta Therapeutics


COVAXIN (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety

COVAXIN (BBV152) Booster Dose Study Demonstrates Robust Immune Responses and Long-Term Safety

Participants receiving a booster dose six months after second dose of COVAXIN™ saw significant increase (>10-fold across Alpha, Beta, Delta and Delta Plus variants) in neutralizing titers compared to baseline at six months Persistence of memory B and T cell immune responses at six months post second dose Pronounced SARS-CoV-2-specific T cell response to COVAXIN™ before and ...

ByOcugen, Inc.


New Data Suggest COVAXIN (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination

New Data Suggest COVAXIN (BBV152) Vaccine Candidate Generates Robust Immune Memory to COVID-19 and Variants of Concern for At Least Six Months After Vaccination

Level of vaccine-induced spike and nucleoprotein antibodies titers demonstrated to be comparable to that following natural infection Immune memory against conserved nucleoprotein may provide an added advantage over spike-only responses Memory T and B cells persisted for at least 6 months post vaccination Data suggest COVAXIN™ (BBV152) may provide protection against current and future ...

ByOcugen, Inc.


Ocugen, Inc. Provides an Update on its Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN (BBV152)

Ocugen, Inc. Provides an Update on its Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN (BBV152)

MALVERN, Pa., Nov. 26, 2021 (GLOBE NEWSWIRE) -- Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that the U.S. Food and Drug Administration (FDA) has issued a clinical hold on the Company’s Investigational New Drug application (IND) to evaluate the COVID-19 vaccine candidate, BBV152, ...

ByOcugen, Inc.


Matica Bio Announces Joint Research Agreement with Sartorius for the Development of Advanced Viral Vector Manufacturing Technology

Matica Bio Announces Joint Research Agreement with Sartorius for the Development of Advanced Viral Vector Manufacturing Technology

” The JRA with Sartorius underscores Matica Bio’s commitment to applying integrated technology and bioprocess solutions to address production complexities like reduction of labor and risk while improving output efficiencies in the production of advanced therapies, including viral vector products. ...

ByMatica Biotechnology, Inc.


Vedanta Announces Positive Topline Phase 2 Data for VE303 in High-Risk C. difficile Infection and Exercise of $23.8 Million Option by BARDA

Vedanta Announces Positive Topline Phase 2 Data for VE303 in High-Risk C. difficile Infection and Exercise of $23.8 Million Option by BARDA

High-dose VE303 in Phase 2 trial achieved primary endpoint, with 31.7% absolute risk reduction in rate of recurrence (or a greater than 80% reduction in the odds of a recurrence) at 8 weeks when compared with placebo Represents most advanced clinical trial of a rationally defined bacterial consortium candidate BARDA exercises $23.8 million option to support Phase 3 clinical trial of VE303, to ...

ByVedanta Biosciences, Inc


BioCardia Reports Second Quarter 2021 Financial Results and Business Highlights

BioCardia Reports Second Quarter 2021 Financial Results and Business Highlights

Business Development In April 2021, the Company entered into an agreement with a Japanese therapeutic partner related to the Helix biotherapeutic delivery product candidates. Under the terms of the agreement, BioCardia received $500,000, a portion of which is creditable for biotherapeutic delivery products and support ...

ByBiocardia, Inc.


City of Hope and Osel Announce Exclusive License for Intellectual Property on the use of Live Biotherapeutic Product CBM588 for Oncology Therapeutic Applications

City of Hope and Osel Announce Exclusive License for Intellectual Property on the use of Live Biotherapeutic Product CBM588 for Oncology Therapeutic Applications

City of Hope®, a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases, and Osel, Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, today announced that City of Hope has granted an exclusive worldwide license to Osel for ...

ByOsel Inc.


Suono Bio, Inc. Announces Oversubscribed Series A Funding Round Led by Axil Capital and Mizuho Securities Principal Investment

Suono Bio, Inc. Announces Oversubscribed Series A Funding Round Led by Axil Capital and Mizuho Securities Principal Investment

Suono Bio, Inc., the company revolutionizing the treatment of gastrointestinal diseases, today announced it has raised an $8.5 million Series A financing led by Axil Capital and Mizuho Securities Principal Investment, with participation by Taiwania Capital and other investors. Suono Bio will utilize the funds to advance its lead programs in inflammatory bowel disease as well as expansion of its ...

BySuono Bio


Vedanta Biosciences Presents New Data from Phase 1 Study of VE202, Its Rationally-Defined Consortium for the Treatment of Inflammatory Bowel Disease, at the International Human Microbiome Consortium Congress 2021 (IHMC)

Vedanta Biosciences Presents New Data from Phase 1 Study of VE202, Its Rationally-Defined Consortium for the Treatment of Inflammatory Bowel Disease, at the International Human Microbiome Consortium Congress 2021 (IHMC)

Results further support the benign safety profile of VE202 and identify an optimal dosing regimen Vedanta plans to initiate a Phase 2 clinical trial of VE202 in ulcerative colitis patients in the second half of 2021 Vedanta Biosciences, a leading clinical-stage microbiome company developing a new category of oral therapies using defined bacterial consortia manufactured from clonal cell ...

ByVedanta Biosciences, Inc


Osel Announces Positive Results from Phase 1b Trial of Live Biotherapeutic Product CBM588 in Combination with Checkpoint Inhibitor (CPI) Therapy in Metastatic Renal Cell Carcinoma

Osel Announces Positive Results from Phase 1b Trial of Live Biotherapeutic Product CBM588 in Combination with Checkpoint Inhibitor (CPI) Therapy in Metastatic Renal Cell Carcinoma

Osel Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, announced today that City of Hope, a world-renowned independent cancer and diabetes research and treatment center, presented data from a Phase 1b trial showing that an LBP, CBM588 (Clostridium butyricum MIYAIRI 588® strain), plus ...

ByOsel Inc.


Ferring, Rebiotix and MyBiotics Collaborate to Develop Live Microbiome-Based Therapeutics in Reproductive Medicine and Maternal Health

Ferring, Rebiotix and MyBiotics Collaborate to Develop Live Microbiome-Based Therapeutics in Reproductive Medicine and Maternal Health

The multi-year agreement combines MyBiotics’ unique culturing, delivery and colonization technologies aimed at restoring microbiome equilibrium with Rebiotix’s expertise in developing clinical-stage live microbiota-based biotherapeutic products and Ferring’s therapeutic development and commercial expertise. ...

ByRebiotix Inc., a Ferring Company

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