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...
Roche Inks Potential $1B AAV Vector Deal with Avista for Eye Disease
Pittsburgh-based Avista Therapeutics has inked a partnership deal with Swiss pharma company Roche to develop AAV gene therapy vectors for eye diseases. The collaboration will use Avista’s single-cell adeno-associated virus (AAV) engineering platform, scAAVengr, to...
Adhera Therapeutics Signs Letter of Intent to Acquire CD71-Targeted Cancer Therapy Paclitaxel Gallium Transferrin
Adhera Therapeutics, Inc. (OTCQB: ATRX), a clinical stage biopharmaceutical company, announces that the Company has entered a Heads of Terms (also known as a Letter of Intent) agreement with Bio Innovation Group to acquire Paclitaxel Gallium Transferrin, a novel...
Amylyx Pharmaceuticals Announces Partnership Agreement with Sunnybrook Research Institute to Identify Novel Drug Candidates for Neurodegenerative Diseases
Amylyx Pharmaceuticals Inc. (NASDAQ: AMLX) announced a two-year sponsored research agreement with Sunnybrook Research Institute (SRI) to expedite the identification of novel drug candidates that inhibit Bax and Bak with high potency, specificity, and appropriate...
Omega Gets FDA Nod to Start First-Ever Epigenomic Controller Trial
Development-stage biotech company Omega Therapeutics announced Thursday that the Investigational New Drug (IND) application for its hepatocellular carcinoma (HCC) candidate, OTX-2002, has received clearance from the U.S. Food and Drug Administration. This clearance...
Regeneron, Sanofi Look to Extend Dupixent into Young Kids with Eosinophilic Esophagitis
In the latest win for Regeneron Pharmaceuticals and Sanofi's Dupixent (dupilumab), the partners announced positive results from a Phase III trial of the blockbuster in kids ages one to 11 years with eosinophilic esophagitis (EoE). Dupixent has been approved globally...