Zynex Announces First Enrollments in Apheresis Donation Clinical Trial with Second Generation Fluid Monitoring System
Zynex, Inc. (Nasdaq: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, rehabilitation, and patient monitoring, announced it has started enrollments in an ongoing apheresis...
Relief Therapeutics and Acer Therapeutics Announce that the European Commission Has Granted Orphan Drug Designation for ACER-001 in Maple Syrup Urine Disease
Relief Therapeutics Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), and its collaboration partner, Acer Therapeutics Inc. (Nasdaq: ACER) (Acer), announced that the European Commission has granted orphan medicinal product designation in the EU to ACER-001 (sodium...
e-Labeling Translations: IFU Localization for Global Markets
What makes e-labeling translations so important in the medical devices industry? With new frontiers in med device markets emerging globally, instructions for use (IFUs) are a requirement in most markets, which makes e-labeling translations for IFUs a necessary...
Pasithea Therapeutics Announces Results of Preclinical Study Demonstrating Tolerizing Vaccine Efficacy in Relapsing-Remitting Model of Multiple Sclerosis
Pasithea Therapeutics Corp. (Nasdaq: KTTA) (Pasithea or the Company), a biotechnology company focused on the discovery, research, and development of new and effective treatments for psychiatric and neurological disorders, announced positive results from a preclinical...
Biora Therapeutics Announces Successful Completion of Device Performance Study in Ulcerative Colitis Patients for its Targeted Therapeutics Platform
Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutics, announced topline results from its recently completed study PM-602: A Scintigraphic Study to Evaluate the Localization and Delivery Function of a Drug Delivery System...
BeiGene and Novartis Make Late-Stage Progress against Liver Cancer
BeiGene and Novartis' unresectable hepatocellular carcinoma treatment is gaining ground as a potential treatment for advanced liver cancer. In the Phase III RATIONALE 301 trial of Tislelizumab as a first-line treatment, the drug met its primary endpoint of...
Innovent Announces First Patient Dosed in Phase 1 Study of IBI324 (VEGF-A/Ang-2 Bispecific Antibody) in Patients with Diabetic Macular Edema
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes high-quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces...
Tarsus Initiates Phase 2a Ersa Trial Evaluating TP-03 for the Treatment of Meibomian Gland Disease
Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), whose mission is to focus on unmet needs and apply proven science and new technology to revolutionize treatment for patients, starting with eye care, announced that it has enrolled the first patient in a Phase 2a clinical...
Gilead Sciences to Acquire MiroBio
Gilead Sciences, Inc. (Nasdaq: GILD) and MiroBio, a privately held U.K.-based biotechnology company focused on restoring immune balance with agonists targeting immune inhibitory receptors, today announced that the companies have entered into a definitive agreement...
Kintara Therapeutics Enters Into Equity Purchase Agreement for Up to $20 Million with Lincoln Park Capital
Kintara Therapeutics, Inc. (Nasdaq: KTRA) (Kintara or the Company), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced it has entered into an equity purchase agreement for up to $20 million with Lincoln Park Capital...
Bio-Thera Solutions Announces First Patient Dosed in Phase 1 Study for BAT8009, an Antibody Drug Conjugate Targeting B7-H3 (CD276) for the Treatment of Advanced Solid Tumors
Bio-Thera Solutions, Ltd., a commercial-stage pharmaceutical company, announced that dosing has begun in a Phase 1 clinical study evaluating BAT8009, an antibody drug conjugate (ADC) that targets B7-H3 (CD276). The clinical trial is a multicenter, open-label Phase 1...
Innovent and Laekna Jointly Announce First Patient Dosed with Three-drug Combination in a Phase 1/2 Study for the Treatment of Patients with Solid Tumors Who Were Resistant to Prior Anti-PD-1/PD-L1 Therapy
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, autoimmune, metabolic, ophthalmology and other major diseases, and Laekna...
Meridian Bioscience Receives Re-Authorization from FDA for its Revogene® SARS-CoV-2 Molecular Assay
Meridian Bioscience, Inc. (NASDAQ: VIVO), a leading global provider of diagnostic testing solutions and life science raw materials, announced that it received re-authorization of its Emergency Use Authorization (EUA) for the Revogene® SARS-COV-2 molecular assay from...
Label Translations: Why Multilingual Desktop Publishing (DTP) is Essential for Regulatory Compliance
With strict guidelines in place for regulating medical labeling worldwide, how does multilingual desktop publishing (DTP) enable companies to comply with content and design requirements during the medical label translation process? For life science companies, all...
Acer Therapeutics and Relief Therapeutics Announce ACER-001 IND Submission for the Treatment of Maple Syrup Urine Disease
Acer Therapeutics Inc. Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, Relief Therapeutics Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration...
Acasti Pharma Announces Initiation of Pharmacokinetic Study for GTX-101, the Company’s Drug Candidate for the Treatment of Postherpetic Neuralgia
Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), announced the initiation of its planned pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug bupivacaine in 48...
Q BioMed announces publication of pre-clinical research showing superior safety and efficacy against current first line therapy of its drug candidate Uttroside-B for liver cancer
Q Biomed Inc. (OTCQB: QBIO) a commercial-stage biotechnology development company announces a new publication supporting the potential superior safety and efficacy of its Uttroside-B chemotherapeutic to treat liver cancer vs the current first line FDA approved drug....
Ashvattha Therapeutics Announces Publication of Data in Science Translational Medicine from Phase 2a Clinical Trial for OP-101 in Severe COVID-19
Ashvattha Therapeutics (“Ashvattha”), a clinical stage company developing novel hydroxyl dendrimer therapeutics, today announced the publication of the results from a Phase 2a clinical study demonstrating a significant reduction in inflammatory and neuroinflammatory...
I-Mab Announces First Patient Dosed in Phase 1 Clinical Trial of Claudin 18.2 and 4-1BB Bispecific Antibody TJ-CD4B in Solid Tumors in China
I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, announced that the first patient in China has been treated with TJ-CD4B (also known as ABL111), a novel...
Takeda Becomes Founding Sponsor of LabCentral to Help Life Sciences Startups Accelerate New Medical Treatments
LabCentral announced that Takeda, a global biopharmaceutical leader headquartered in Japan with a global U.S. hub located in Massachusetts, will become a LabCentral Founding Sponsor. Takeda will supply funding over a period of three years to support LabCentral's...