Formulation Development
Celldex Presents Positive Interim Results From Phase 1 Study
Celldex Therapeutics, Inc. recently presented interim data from the company’s CD40 agonist program in a late-breaking poster session today at the American Association for Cancer…
Triphase Accelerator Initiates Phase 1 Clinical Trial of TRPH-222 in B-cell Lymphoma
Triphase Accelerator Corporation, a company dedicated to acquiring and developing novel therapeutics for the treatment of cancer, and Catalent, the leading global provider of advanced…
CURE Pharmaceutical to Acquire Chemistry Holdings Inc.
CURE Pharmaceutical, an innovative drug delivery and development company, recently announced that it has agreed to acquire Chemistry Holdings Inc., a formulation technology company that is developing innovative delivery systems for a variety of industries, in an all-stock transaction.
Fusion Pharmaceuticals Announces $105-Million Financing
Fusion Pharmaceuticals, a clinical-stage biopharmaceutical company developing targeted alpha-particle radiotherapeutics for treating cancer, recently announced the completion of a $105 million Series B financing led by Varian and new investor OrbiMed.
AMORPHOUS SOLID DISPERSIONS - Increasing Solubility From API to Tablets
Paulo Lino, PhD, and João Henriques discuss the main development goals and present a framework for a streamlined development of amorphous solid dispersion formulations by spray drying.
FORMULATION FORUM - Revitalization of Older Drug Products Using Innovative Formulation Technologies by 505(b)(2) Regulatory Pathway
Jim Huang, PhD, says more than 50% of approved drugs on the market contain poorly water soluble APIs, which typically are associated with poor bioavailability, suboptimal drug delivery, ineffective drug efficacy, and side effects, and this creates a huge opportunity in generating 505(b)(2) products.
DRUG DISCOVERY - Zebrafish in Preclinical Drug Development - A Small Fish With Big Returns
Rafael Miñana, PhD, explores the benefits of preclinical outsourcing, the value of zebrafish as an alternative model, as well as the challenges and opportunities of managing a highly diversified portfolio and providing customized solutions.
GLOBAL REPORT – 2018 Global Drug Delivery & Formulation Report: Part 2, Notable Product Drug Delivery and Formulation Approvals of 2018
In part 2 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, focuses on how the pharmaceutical industry has harnessed well validated drug delivery and formulation technologies to deliver important product approvals in 2018.
SPECIAL FEATURE - Excipients: Formulators Want Excipients for Solubility & Beyond
Contributor Cindy H. Dubin speaks with leading excipient companies to discuss the current role excipients are playing in continuous manufacturing, biopharma formulation, and controlled- and immediate-release delivery.
THERAPEUTIC FOCUS - Targeting the Novel LANCL2 Pathway Offers Potential for a Differentiated Treatment Paradigm for Autoimmune Diseases
Andrew Leber, PhD, Raquel Hontecillas, PhD, and Josep Bassaganya-Riera, PhD, say current IBD therapeutics have mediocre efficacy, poor maintenance of response, and damaging side effects, including cancer, infection, and death, resulting in an unmet clinical need for safer and more effective oral therapeutics.
Calithera Biosciences Initiates Phase 1/2 Trial; Part of Pfizer Collaboration
Calithera Biosciences, Inc. recently announced the first patient has been treated in the Phase 1/2 open-label clinical trial of the glutaminase inhibitor telaglenastat (CB-839) in…
Race Oncology Files IND With FDA for Cancer Drug
Race Oncology Limited recently announced the US Food and Drug Administration has received its Investigational New Drug (IND) application for the company’s cancer drug Bisantrene.…
Novel Compound for Treating TBI Demonstrates Positive Results
Ischemix, Inc. recently announced significant results from a randomized, double-blinded, placebo-controlled preclinical study of its drug, CMX-2043, for the treatment of TBI. The company plans to…
Swedish Biomimetics 3000 Ltd Invents Groundbreaking Continuous Peptide Manufacturing Process
μLOT is an entirely new approach to manufacturing of therapeutic peptides, which promises to completely replace traditional large-scale batch manufacturing. The µLOT technology platform provides…
ExCellThera Announces Clearance by FDA & Health Canada for New Clinical Trials
ExCellThera Inc. recently announced its lead technology, ECT-001, will be used as part of two new clinical trials in patients with high-risk leukemia. The announcement…
Autolus Therapeutics Unveils Next-Generation Technology & Pipeline
Autolus Therapeutics plc, a clinical-stage biopharmaceutical company developing next generation programmed T cell therapies for the treatment of cancer, recently presented insights into the science behind tumor defense mechanisms and the company’s novel programmed T cell therapy programs in development.
Amyris Delivers on First CBD Milestone; Collaboration Worth $300 Million
Amyris, Inc. recently announced it successfully delivered on its first milestone for its cannabinoid partner, LAVVAN, earning its first payment of $10 million, which is part of a $300-million collaboration before future royalty payments.
Cytovation Initiates Clinical Development Program for First-in-Class Agent for Tumor Immunotherapy
Cytovation AS recently announced the first patients have been treated in a Phase I clinical study with CyPep-1, a novel therapeutic agent being developed as…
NapaJen Pharma & Astellas Pharma Establish Research Collaboration for Discovery & Development of Novel Oligonucleotides
NapaJen Pharma, Inc. recently announced it has entered into a research collaboration with Astellas Pharma Inc. for the discovery and development of novel oligonucleotide therapeutics.…
Innovate Biopharmaceuticals Reports Financing to Initiate Phase 3 Clinical Trial
Innovate Biopharmaceuticals, Inc. recently announced it closed its previously announced equity financing, resulting in gross proceeds of $9.7 million. The company expects to use the…
