Formulation Development
Lin BioScience Receives FDA Fast Track Designation For LBS-007
Lin BioScience recently announced its lead pipeline, LBS-007, has been granted Fast Track Designation by the US FDA for the treatment of acute myeloid leukemia.…
Marinomed Biotech AG Signs Agreement for Sale of Carragelose Business to Unither Pharmaceuticals
Marinomed Biotech AG has signed an agreement on the sale of its Carragelose business to the French CDMO Unither Pharmaceuticals. The contract provides for upfront…
Nutriband Receives Patent Notice of Publication for its Abuse Deterrent Transdermal Technology
Nutriband Inc. recently announced it has received a Notice of Publication of the Registration and Grant of a Standard Patent (R) from the Hong Kong…
Anocca Announces Submission of Clinical Trial Application for Multi-Asset Trial VIDAR-1 in Advanced Pancreatic Cancer
Anocca AB recently announced the submission of its first Clinical Trial Application (CTA) to the European Medicines Agency (EMA) for a Phase 1/2 multi-asset umbrella…
Greenwich LifeSciences Partners With GIM in Italy
Greenwich LifeSciences, Inc. recently announced its partnership with clinical sites in Italy. The company has partnered with Gruppo Italiano Mammella (GIM), the largest academic cooperative…
Anavex Life Sciences Announces Submission of Blarcamesine MAA for Treatment of Alzheimer’s Disease to EMA
Anavex Life Sciences Corp. recently announced the submission of the blarcamesine (ANAVEX2-73) MAA (Marketing Authorization Application) to the European Medicines Agency (EMA). The MAA submission…
Otsuka Submits NDA for Bempedoic Acid in the Treatment of Hypercholesterolemia
Esperion recently announced that Otsuka Pharmaceutical Co., Ltd. (Otsuka) has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare…
Renexxion Ireland Announces Issuance of Fifth New US Patent Covering Novel Crystal Isoform of Naronapride
Renexxion Ireland Limited recently announced a major milestone in its intellectual property portfolio. The United States Patent and Trademark Office (USPTO) has granted the fifth…
Gelteq Announces 400,000 Units Enter Production in November 2024
Gelteq Limited recently announced that in November, 400,000 units of its gel solution are entering into production. These units will fulfill orders made for clients…
Adragos Pharma Acquires Leading Swiss Sterile Fill-Finish Expert
Adragos Pharma has acquired Baccinex, a Swiss-based expert in aseptic fill-finish manufacturing. This acquisition significantly enhances Adragos’ sterile manufacturing capabilities and marks a pivotal step…
Kanglin Biotechnology Announces $20-Million Financing to Advance the Development of Gene Therapies
Kanglin Biotechnology (Hangzhou) Co., Ltd, an innovative biotech company developing the next generation of gene therapies, recently announced the successful completion of a Series A…
IMUNON Announces Results From its End-of-Phase 2 Meeting With the FDA for its Lead IMNN-001 Clinical Program in Advanced Ovarian Cancer
IMUNON, Inc. recently announced the outcome of its recent End-of-Phase 2 in-person meeting with the US FDA, supporting the advancement of its investigational interleukin-12 (IL-12)…
Tenaya Therapeutics Doses First Patient in Phase 1b Clinical Trial for the Treatment of PKP2-Associated Arrhythmogenic Right Ventricular Cardiomyopathy
Tenaya Therapeutics, Inc. recently announced the first patient has been dosed with TN-401 gene therapy in the RIDGE-1 Phase 1b clinical trial at the University…
CASE STUDY - Overcoming Barriers to Patient Adherence With A Novel Dosage Form
In this CPHI Award-winning case study, learn how Adare scientists took the alternative sprinkle version out of the lab and into the hands of patients.
ARTICLE - A New Framework for Identifying Nitrosamine Risks & Efficiently Derisking Products
Adare’s team of nitrosamine experts have developed a straightforward framework that simplifies the identification of at-risk APIs.
OncoVerity Secures Extended Series A to Advance Cusatuzumab in Newly Diagnosed AML
OncoVerity recently announced the closing of a Series A extension financing led by existing investors, argenx and RefinedScience. With this funding, OncoVerity aims to advance…
Lipella Pharmaceuticals Announces Completion of First Cohort in Phase 2a Trial of LP-310 for Oral Lichen Planus, Advancing to Next Dose Group
Lipella Pharmaceuticals Inc. recently announced the completion of dosing for the first cohort in its multi-center Phase 2a clinical trial of LP-310, a liposomal-tacrolimus oral…
UMDF & Khondrion Announce The Mito Fund’s Investment in Khondrion to Support Development of One of the Most Advanced Drug Candidates for Primary Mitochondrial Disease
The United Mitochondrial Disease Foundation’s (UMDF) venture philanthropy arm, The Mito Fund, has invested in Khondrion, a Netherlands-based clinical stage biopharmaceutical company discovering and developing therapies…
BriaCell Announces First Patient Dosed With Bria-OTS in Metastatic Breast Cancer Study
BriaCell Therapeutics Corp. recently announced the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673) to evaluate the safety and efficacy of…
Dyadic Receives $3 Million Grant to Develop Cost-Effective Monoclonal Antibodies for RSV & Malaria Using C1 Platform Technology
Dyadic International, Inc. recently announced it has been awarded a $3 million grant from the Gates Foundation for the cell line development of monoclonal antibodies…
