Formulation Development
Gracell Biotechnologies Doses First Patient in Phase 2 Portion of Registrational Phase 1/2 Clinical Trial Evaluating Treatment of B-cell Acute Lymphoblastic Leukemia
Gracell Biotechnologies Inc. recently announced the first patient has been dosed in the Phase 2 portion of its registrational Phase 1/2 clinical trial evaluating GC007g…
Bora Pharmaceutical Makes Strategic Appointment to Strengthen Global Manufacturing Capabilities
Bora Pharmaceuticals, a full-service contract development and manufacturing organization (CDMO), recently appointed Don Liscombe as its Vice President and General Manager to lead its flagship…
PTC Provides Update on Ongoing Global PIVOT-HD Trial For PTC518
PTC Therapeutics, Inc. recently announced enrollment is active and ongoing for its Phase 2 PIVOT-HD trial of PTC518 for the treatment of Huntington's disease at…
Alvotech & JAMP Pharma Expand Exclusive Partnership Adding Two Biosimilar Candidates, Bringing New Options for Patients in Specialty Care
Alvotech and the JAMP Pharma Group recently announced the companies have expanded their exclusive partnership to commercialize biosimilars developed and manufactured by Alvotech, by adding…
Jazz Pharmaceuticals & Zymeworks Announce Exclusive License Agreement
Jazz Pharmaceuticals plc and Zymeworks Inc. recently announced Jazz and Zymeworks’ subsidiary, Zymeworks BC Inc., have entered into an exclusive licensing agreement under which Jazz will acquire….
Societal CDMO Announces Signing of Multiple New CDMO Service Agreements
Societal CDMO, Inc. recently announced it has signed CDMO service agreements with two new customers. These contracts are focused on a range of analytical method, technical transfer, formulation, manufacturing and….
Silo Pharma Announces Data Supporting Therapeutic Potential of SPC-14 for Alzheimer’s Disease in Preclinical Study
Silo Pharma, Inc. recently announced proof-of-concept data supporting the therapeutic potential of SPC-14 as a treatment for Alzheimer's disease (AD), as demonstrated in a mouse…
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…
