Formulation Development
First European Union Patient Dosed With 177Lu-PNT2002 in the Phase 3 SPLASH Trial
POINT Biopharma Global Inc. recently announced the first patient in the European Union (EU) has been dosed in the Phase 3 SPLASH trial (NCT04647526). The SPLASH trial….
Prothena Receives FDA Fast Track Designation for Next-Generation Anti-Amyloid Beta Antibody Under Investigation for the Treatment of Alzheimer’s Disease
Prothena Corporation plc recently announced the US FDA has granted Fast Track designation for PRX012, a potential best-in-class anti-amyloid beta (Aβ) antibody therapy currently being…
GeoVax Announces Issuance of Malaria Vaccine Patent
GeoVax Labs, Inc. recently announced the US Patent and Trademark Office has issued Patent No. 11,311,612 to GeoVax, pursuant to the company’s patent application No.…
Editas Medicine Receives FDA Rare Pediatric Disease Designation for the Treatment of Beta Thalassemia
Editas Medicine, Inc. recently announced US FDA granted Rare Pediatric Disease designation to EDIT-301, an investigational, gene-edited medicine for the treatment of beta thalassemia. The…
Taconic Biosciences & Biomodels Establish Microbiome Initiative
Taconic Biosciences and Biomodels have recently launched the Taconic-Biomodels Microbiome Initiative (TBMI), providing investigators with seamless access to complete germ-free and gnotobiotic microbiome study solutions, from design to data….
Sol-Gel Technologies & Galderma Announce FDA Approves First Topical Rosacea Treatment With Microencapsulated BPO
Sol-Gel Technologies, Ltd. recently announced the Food and Drug Administration (FDA) approval of its drug product, EPSOLAY, a proprietary cream formulation of….
WHITE PAPER - Making Sub-Visible Particles Visible: Innovative Analytical Techniques for Detection & Identification
The demand for complex, often life-saving drug substances such as monoclonal antibodies, interferons, and peptides is on the rise, creating a greater need for innovative delivery mechanisms to administer these new therapeutics. For a variety of reasons, sub-visible particles….
Catalent Acquires Commercial-Scale Cell Therapy Development & Manufacturing Facility From Erytech
Catalent recently announced it has acquired from Erytech Pharma its state-of-the-art, commercial-scale cell therapy manufacturing facility in Princeton, NJ, for $44.5 million. The deal includes…
Starton Therapeutics Doses First Subjects in Phase 1 Clinical Trial of STAR-LLD Continuous Delivery Lenalidomide
Starton Therapeutics Inc. recently announced it has dosed the first subjects in a first-in-human Phase 1 STAR-LLD clinical trial of its investigational continuous delivery lenalidomide,…
Priothera Receives FDA Clearance of IND to start Phase 2b/3 Study With Mocravimod in AML Patients Undergoing Allogeneic HSCT
Priothera Ltd recently announced the US FDA has provided clearance to proceed with the company's Investigational New Drug (IND) application to begin its pivotal Phase…
Lonza Early Development Services & Integral Molecular to Offer Complementary Expertise to Enhance Early De-Risking of Biotherapeutics
Lonza and Integral Molecular recently announced a strategy to offer complementary expertise to their respective customers to better assess the risks of off-target binding of…
Blacktrace Launches Particle Works – The New Dedicated Particle Engineering Brand
Particle Works’ game-changing particle engineering platforms are set to revolutionize the way customers discover, develop and scale-up particle production for a wide range of….
WHITE PAPER - Poloxamer: A Simple & Powerful Solution for Accelerating Dissolution
This white paper will introduce the concept of dissolution and discuss how poloxamers are a simple yet powerful formulation approach that can enhance dissolution rate, while minimizing resource requirements.
EpicentRx BETA-PRIME Phase 1 Study Progresses After Demonstrating Good Safety & Tolerability
EpicentRx Inc. recently announced the initiation of the next stage of its Phase 1 trial, BETA-PRIME, with AdAPT-001, a TGF-beta (TGFß) trap-enhanced cancer targeting adenovirus.…
Catalent to Invest $350 Million in Integrated Biologics Drug Substance & Drug Product Manufacturing
Catalent recently announced a multi-year $350-million investment at its facility in Bloomington, IN, to expand biologics drug substance and drug product manufacturing….
Brooklyn ImmunoTherapeutics Announces Establishment of New R&D Facility for Advancement of Engineered Cellular Medicines
Brooklyn ImmunoTherapeutics, Inc. recently announced the establishment of a new corporate and research and development facility at The Boardwalk at Science Center Drive in San Diego, CA, to support translational….
Cocrystal Pharma Collaborates With the NIAD to Evaluate COVID-19 Protease Inhibitors
Cocrystal Pharma, Inc. recently announced a Non-Clinical Evaluation Agreement (NCEA) with the National Institute of Allergy and Infectious Diseases (NIAID) for exploratory preclinical studies to….
Enzyvant Announces Plans to Expand Regenerative Medicine Manufacturing Capabilities
Enzyvant recently announced plans to develop a Good Manufacturing Practice (GMP)-compliant regenerative medicine manufacturing facility in Morrisville, NC, part of the Research Triangle Park area.…
Blue Water Vaccines Presents New Data Supporting Universal Influenza Vaccine Candidate
Blue Water Vaccines Inc. recently issued the below statement regarding its Form 8-K filed with the Securities and Exchange Commission (SEC) on April 20, 2022,…
ProMed Pharma Announces Preclinical Rat Study to Assess Pharmacokinetics of Novel Long-Acting Contraceptive Implant
ProMed Pharma recently announce the initiation of preclinical evaluation of a novel fully resorbable contraceptive implant. The implant, developed in a project funded by the Bill & Melinda….
