Stem Cell Clinic

Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces…

By Global News Feed

ISELIN, N.J., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to achieve FDA approval for the first ophthalmic formulation of bevacizumab for the treatment of retinal diseases, today announced that it has received written agreement from the FDA under an SPA for the NORSE EIGHT clinical trial protocol evaluating ONS-5010 in neovascular age-related macular degeneration (AMD) subjects. Additionally, Outlook Therapeutics entered into securities purchase agreements with certain institutional and accredited investors for up to $172 million in gross proceeds to fund the advancement of ONS-5010.

Read more:
Outlook Therapeutics® Receives FDA Agreement Under Special Protocol Assessment (SPA) for 90 Day Non-Inferiority Study, NORSE EIGHT, and Announces...

4DMT Receives Rare Pediatric Disease Designation from FDA for Aerosolized 4D-710 for Treatment of Cystic Fibrosis Lung Disease

By Global News Feed

EMERYVILLE, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for the Company’s product candidate aerosolized 4D-710 for treatment of cystic fibrosis (CF) lung disease. 4D-710 is being evaluated in the Phase 1/2 AEROW clinical trial in people with CF who are not eligible for, or cannot tolerate any of, the currently approved CFTR modulators.

See the original post here:
4DMT Receives Rare Pediatric Disease Designation from FDA for Aerosolized 4D-710 for Treatment of Cystic Fibrosis Lung Disease

NAYA Biosciences To Acquire Clinical Stage Gene Therapy Program for Leber’s Hereditary Optic Neuropathy (LHON)

By Global News Feed

AVENTURA, Fla. and SARASOTA, Fla., Jan. 23, 2024 (GLOBE NEWSWIRE) -- NAYA Biosciences Inc. ("NAYA"), a company which has recently signed a definitive merger agreement with INVO Bioscience to establish an expanded, publicly-traded life science company dedicated to increasing patient access to breakthrough treatments in oncology, regenerative medicine, and fertility, today announced that it has entered into a binding letter of intent to acquire Florida Biotechnologies, Inc. a gene therapy company focusing on the treatment of mitochondrial diseases.

Read more:
NAYA Biosciences To Acquire Clinical Stage Gene Therapy Program for Leber's Hereditary Optic Neuropathy (LHON)

Recce Pharmaceuticals Reports Positive Phase I/II Trial Results of RECCE® 327 for the Treatment of Diabetic Foot Infections

By Global News Feed

SYDNEY, Australia, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Recce Pharmaceuticals Ltd (ASX: RCE, FSE: R9Q), (the Company), the Company developing a new class of synthetic anti-infectives, today announced positive results from a Phase I/II trial assessing the safety and efficacy of its lead synthetic anti-infective candidate, RECCE® 327 (R327), in patients with diabetic foot infections (DFI).

Go here to read the rest:
Recce Pharmaceuticals Reports Positive Phase I/II Trial Results of RECCE® 327 for the Treatment of Diabetic Foot Infections

Rezolute Receives Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group for RZ358 in the Treatment of…

By Global News Feed

REDWOOD CITY, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Rezolute, Inc. (Nasdaq: RZLT), a clinical-stage biopharmaceutical company committed to developing novel, transformative therapies for serious metabolic and rare diseases, today announced that the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the innovative medicine designation, the Innovation Passport, to RZ358 for the treatment of hypoglycemia due to congenital hyperinsulinism (HI). The Innovation Passport designation was granted based on the substantial unmet medical need in this condition and the potential for RZ358 to benefit patients as evidenced by the Phase 2 RIZE study in congenital HI, which safely demonstrated significant improvements in hypoglycemia events.

See more here:
Rezolute Receives Innovation Passport Designation from the U.K. Innovative Licensing and Access Pathway Steering Group for RZ358 in the Treatment of...

Diagnostics Industry Leader Jack Kenny Appointed as Chairman of the Board at Biomerica

By Global News Feed

IRVINE, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Biomerica, Inc. (NASDAQ: BMRA), a global biomedical company leading the way in innovative gastroenterology solutions, today announced the appointment of Jack Kenny, former CEO and board member of Meridian Bioscience, Inc., to serve as the Chairman of the Board of Directors of Biomerica. Mr. Zack Irani will continue to serve as CEO. Mr. Kenny joined the Biomerica Board of Directors in August 2023 as an independent director.

See the article here:
Diagnostics Industry Leader Jack Kenny Appointed as Chairman of the Board at Biomerica

Artelo Biosciences Announces Publication of New Peer-Reviewed Pre-Clinical Research Demonstrating ART26.12’s Effectiveness in Treating and…

By Global News Feed

SOLANA BEACH, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Artelo Biosciences, Inc. (Nasdaq: ARTL), a clinical-stage pharmaceutical company focused on modulating lipid-signaling pathways to develop treatments for people living with cancer, pain, and neurological conditions, today announced new research published in the peer-reviewed Journal of Pain. The research article, titled “Discovery and preclinical evaluation of a novel inhibitor of FABP5, ART26.12, effective in Oxaliplatin-induced Peripheral Neuropathy,” highlights Artelo’s pre-clinical asset, ART26.12, and its potential ability to treat and prevent Oxaliplatin-Induced Peripheral Neuropathy (OIPN) in a series of separate studies.

See the rest here:
Artelo Biosciences Announces Publication of New Peer-Reviewed Pre-Clinical Research Demonstrating ART26.12’s Effectiveness in Treating and...

Vivtex Enters Research Collaboration with Astellas Pharma

By Global News Feed

Cambridge, MA, USA and Zurich, Switzerland – 23rd January 2024. Vivtex Corporation (“Vivtex” or “the Company”), a biotech company aiming to transform the development of oral biologic therapies for major diseases, announces that it has entered a research collaboration with Astellas Pharma Inc. (“Astellas”), a global pharmaceutical company. The collaboration is focused on the evaluation of Vivtex’s unique and proprietary GI-ORIS™ (“Gut on a chip” and AI) screening and formulation platform technology to support the development of novel, oral versions of a therapeutic candidate provided by Astellas.

Go here to read the rest:
Vivtex Enters Research Collaboration with Astellas Pharma

→←