ELIMINATE trial is evaluating LBP-EC01 for treating urinary tract infections caused by drug-resistant E. coli
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Locus Biosciences Announces $23.9 Million in Funding from BARDA to Support First Phase 2 Trial of CRISPR-engineered Bacteriophage Therapy
MONTREAL, Jan. 23, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, has received correspondence from the U.S. Food and Drug Administration (FDA) regarding the Company’s supplemental Biologics License Application (sBLA) for the F8 formulation of tesamorelin. The FDA has notified the Company that it is continuing its review of the application beyond the Prescription Drug User Fee Act (PDUFA) goal date of January 22, 2024. Further information will be provided in due course.
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Theratechnologies Receives Update from FDA on Tesamorelin F8 Supplemental Biologic License Application
Partnership Aims to Optimize Quality Control and Assurance Through Digital AI Histopathology Services Partnership Aims to Optimize Quality Control and Assurance Through Digital AI Histopathology Services
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iSpecimen and TriMetis Life Sciences Announce Strategic Partnership to Help Transform Tissue-Based Research
NORWOOD, Mass., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), announced today that the abstract for the first-in-human Phase 1 dose escalation study of SYS6002 (CRB-701) has been released, and the corresponding up-to-date data will be presented at the 2024 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). The data referred to in the abstract dates to September of 2023; the upcoming presentation will include data as of December 2023. The study is being conducted by Corbus’s partner CSPC Pharmaceutical Group in China. ASCO GU will be held January 25-27, 2024 in San Francisco, CA and online.
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Phase 1 Clinical Data for SYS6002 (CRB-701) to be presented at 2024 ASCO GU
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.
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.
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4DMT Receives Rare Pediatric Disease Designation from FDA for Aerosolized 4D-710 for Treatment of Cystic Fibrosis Lung Disease
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.
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).
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Recce Pharmaceuticals Reports Positive Phase I/II Trial Results of RECCE® 327 for the Treatment of Diabetic Foot Infections
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.
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.
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Diagnostics Industry Leader Jack Kenny Appointed as Chairman of the Board at Biomerica