Formulation Development
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….
Ultragenyx Announces First Patient Dosed in Pivotal Phase 2/3 Clinical Study for the Treatment of Osteogenesis Imperfecta
Ultragenyx Pharmaceutical Inc. recently announced the first patient has been dosed in a clinical study for the treatment of Osteogenesis Imperfecta (OI) in patients….
Processa Pharmaceuticals Doses First Patient in Amended Phase 1B Protocol for PCS6422 Combined With Capecitabine (Next-Generation Capecitabine)
Processa Pharmaceuticals, Inc. recently announced the first patient with advanced, refractory gastrointestinal cancer has been dosed in its amended maximum tolerated dose (MTD) Phase 1B…
BioXcel Therapeutics Announces Formation of OnkosXcel Therapeutics to Develop Medicines Focused in Oncology
BioXcel Therapeutics, Inc. recently announced the formation of wholly owned subsidiary OnkosXcel Therapeutics, Inc. to develop transformative medicines in….
KemPharm Doses First Subject in Phase 1 Clinical Trial Evaluating Cardiovascular Safety of Serdexmethylphenidate
KemPharm, Inc. recently announced the first subject has been dosed in a Phase 1 clinical trial designed to assess the relative cardiovascular safety of serdexmethylphenidate…
TFF Pharmaceuticals Announces Safety & Pharmacokinetic Data From Phase 1 Study of Niclosamide Inhalation Powder
TFF Pharmaceuticals, Inc. recently announced safety and pharmacokinetic (PK) data from its Phase 1 study of Niclosamide Inhalation Powder, which is being developed for the…
Revive Therapeutics Announces Publication of Research Data With Bucillamine in COVID-19
Revive Therapeutics Ltd. recently announced the publication of a scientific article evaluating the impact of medication, including Bucillamine, on antibody response to SARS-CoV-2 mRNA vaccines…
NEC & Shionogi Enter Strategic Research Collaboration for Novel Hepatitis B Therapeutic Vaccine
NEC Corporation and Shionogi & Co., Ltd. recently announced the execution of a strategic research collaboration agreement for the development of a novel hepatitis B therapeutic….
Black Diamond Therapeutics Announces First Patient Dosed in Phase 1 Study for MasterKey Inhibitor of EGFR for the Treatment of Glioblastoma & Non-Small Cell Lung Cancer
Black Diamond Therapeutics, Inc. recently announced the dosing of the first patient in the Phase 1 study evaluating BDTX-1535, a MasterKey inhibitor of epidermal growth…
Ocugen to Commercialize COVAXIN in Mexico, Rights Now Encompassing All of North America
Ocugen, Inc. and Bharat Biotech recently announced they have entered into an amendment to their Co-development, Supply and Commercialization Agreement to expand Ocugen’s exclusive….