Formulation Development
Aragen to Operationalize Cutting-Edge Formulation Manufacturing Facility
Aragen recently announced it will operationalize its state-of-the-art formulation manufacturing facility in the Mallapur campus, Hyderabad, India, by January 2023. The 12,000-sq-ft new facility will…
Enrollment Completed in Phase 3 PATHFNDR-1 Study Evaluating Oral Paltusotine for the Treatment of Acromegaly
Crinetics Pharmaceuticals, Inc. recently announced the completion of enrollment in the Phase 3 PATHFNDR-1 study. PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 studies evaluating…
VBI Vaccines & Agenus Announce Collaboration to Evaluate VBI-1901 in Combination With Anti-PD-1 Balstilimab in a Phase 2 Study in Primary Glioblastoma Patients
VBI Vaccines Inc. and Agenus recently announced a collaboration to evaluate the combination of VBI-1901, VBI’s cancer vaccine immunotherapeutic, and balstilimab, Agenus’ monoclonal….
Tavros Therapeutics & Vividion Therapeutics Announce Strategic Collaboration to Discover & Enhance Targeted Oncology Programs
Tavros Therapeutics and Vividion Therapeutics, Inc. recently announced the companies have entered into a collaboration agreement to discover or target four oncology targets across an initial 5-year term…..
BriaCell Announces New Clinical Trial Site to Bring Novel Cancer Treatments to Advanced Breast Cancer Patients
BriaCell Therapeutics Corp. recently announced today it has added Mayo Clinic, Jacksonville, FL, as a clinical site in the Phase 1/2 study of BriaCell’s lead…
Forge Biologics Announces Updated Positive Clinical Data in RESKUE, a Novel Phase 1/2 Gene Therapy Trial for Patients With Krabbe Disease
Forge Biologics recently announced Chief Medical Officer Maria Escolar, MD, MS, presented updated clinical data from the RESKUE Phase 1/2 clinical trial for FBX-101—the company’s…
FORMULATION FORUM - Lipid Nanoparticles: Tackling Solubility Challenges With Lipid-Based Technologies for Oral & Injectable Formulations
Jim Huang, PhD, and Shaukat Ali, PhD, believe as more hydrophobic or brick dust and/or lipophilic or waxy molecules come out of discovery, amorphous solid dispersions (ASDs) and lipid based self-emulsifying microemulsions, nanoemulsions, liposomes, and nanoparticles are ideal for oral and injectable formulations.
HUTCHMED Initiates a Phase 2/3 Trial of Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia
HUTCHMED (China) Limited recently announced it has initiated a Phase 2/3 trial of sovleplenib in adult patients with warm antibody autoimmune hemolytic anemia….
FDA Approves New Treatment Option for Patients With ALS
The US FDA approved Relyvrio (sodium phenylbutyrate/taurursodiol) to treat patients with amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig’s disease. “This approval provides another…
Daré Bioscience Announces IDE Approval for a Single Arm, Open-Label Pivotal Contraceptive Efficacy Study of Investigational Hormone-Free Monthly Intravaginal Contraceptive
Daré Bioscience, Inc. recently announced the US FDA approved an Investigational Device Exemption (IDE) application allowing Daré to conduct a single arm, open-label pivotal contraceptive…
Silo Pharma Initiates Toxicity Study of its Proprietary Ketamine Formulation for Treatment of Fibromyalgia
Silo Pharma, Inc. recently announced it has initiated a preclinical toxicity study of its novel time-released, dosage controlled formulation of ketamine, designated as….
Opiant Pharmaceuticals Announces Completion of Enrollment in Phase 2 Clinical Trial of Nasal Naltrexone in Patients With Alcohol Use Disorder
Opiant Pharmaceuticals, Inc. recently announced the last patient has been enrolled in the Phase 2 clinical trial of OPNT002, nasal naltrexone, for patients with….
Two Cell & Gene Therapies Manufactured at Lonza Houston Reach US FDA Approval
Lonza recently announced two additional cell and gene therapies manufactured at its Houston (US) site have reached commercial approval in Q3 2022. ZYNTEGLO, for the…
Mustang Bio Announces First Patient Treated in Its Multicenter Phase 1/2 Clinical Trial of a First-in-Class CD20-targeted, Autologous CAR T Cell Therapy
Mustang Bio, Inc. recently announced the first patient has been treated in its multicenter, open-label, non-randomized Phase 1/2 clinical trial evaluating the safety and efficacy…
Monopar Announces Completion of Phase 2b Enrollment & Commencement of Phase 3 Enrollment in its VOICE Trial for Severe Oral Mucositis
Monopar Therapeutics Inc. recently announced an update on its actively enrolling Validive Phase 2b/3 VOICE clinical trial for the prevention of severe oral mucositis (SOM)…
MBX Biosciences Advances Phase 1 Clinical Trial of Long-Acting Parathyroid Hormone Peptide Prodrug
MBX Biosciences, Inc. recently announced it has initiated the multiple ascending dose portion of its ongoing Phase 1 clinical trial of MBX 2109. MBX 2109,…
Icosavax Initiates Phase 1 Trial of IVX-A12 Against RSV & hMPV in Older Adults
Icosavax, Inc. recently announced the initiation of a Phase 1 clinical trial of IVX-A12, a combination bivalent RSV and hMPV VLP vaccine candidate, in older…
Nutriband & Kindeva Drug Delivery Demonstrate Enhanced Abuse-Deterrent Characteristics for Aversa Fentanyl
Nutriband Inc. and Kindeva Drug Delivery have demonstrated enhanced abuse deterrence kinetics of the company’s patented lead product, Aversa Fentanyl, an abuse-deterrent fentanyl transdermal system….
EXTRACELLULAR VESICLES - Engineering Extracellular Vesicles to Create Next-Generation Therapeutics
David Lowe, PhD, Justin Hean, PhD, Dave Carter, PhD, and Antonin de Fougerolles, PhD, say EVs exhibit key properties that make them extremely attractive as therapeutics, particularly their safety profile and potential for low immunogenicity. In order to effectively unlock this potential, some key challenges remain, such as the development of EV product manufacture and characterization methodologies and rapid pharmacokinetics.
MEDICAL DEVICE TESTING - Chemical Characterization & the Non-Targeted Analysis of Medical Devices
Luminita Moraru, MSC, MRSC, says the medical devices industry is in continuous growth, and the development of new reliable and accurate approaches in order to assess the safety of the products should constantly be reviewed.
