Formulation Development
Cynata’s Stem Cell Therapy Meets All Safety & Efficacy Endpoints in Trial
Australian stem cell and regenerative medicine company Cynata Therapeutics Limited recently announced that CYP-001, its lead Cymerus mesenchymal stem cell (MSC) product candidate, met all clinical endpoints in a Phase 1 trial for the treatment of steroid-resistant acute graft-versus-host disease (GvHD).
Emergent BioSolutions to Acquire ADAPT Pharma
ADAPT Pharma recently announced it has entered into a definitive agreement to be acquired by Emergent BioSolutions. Adapt is solely focused on helping address the opioid overdose and addiction crisis.
CONTROLLED RELEASE - Informed Selection of Modified-Release Technologies Provides Simpler Oral Dose Regimens
Ronak Savla, PhD, reviews some of the physicochemical and biopharmaceutical characteristics of drugs and how they influence creation of a controlled drug delivery formulation.
DRUG DEVELOPMENT - Cell & Gene Therapies Calling for Innovation in Drug Development
Lev Gerlovin and Pascale Diesel, PharmD, believe there is significant evidence to indicate that we are entering a golden age of gene and cell therapy development, and while industry works to advance these programs, the debate over new approaches in both structuring and financing clinical research is likely to continue.
LIPID-BASED DELIVERY - Advanced Lipid-Based Drug Delivery Systems: Solid Lipid Nanoparticles & Nanostructured Lipid Carriers
John K. Tillotson, RPh, PhD, believes increased research and development of these drug delivery platforms will continue to advance therapeutic efficacy and safety for emerging difficult-to-deliver actives.
HIGH-RESOLUTION MASS SPECTROMETRY - A Map to Biologics
William Boomershine, PhD, explains how high-resolution mass spectrometry is a key component to the characterization of novel biologics and biosimilars.
DRUG DELIVERY - Targeted Delivery of Submicron Particle Cancer Chemotherapy: Helping Shift the Immunotherapy Paradigm
Marc A. Iacobucci says that with much attention and research investment into IOT, NanOlogy is shaping a new paradigm for cancer treatment by attempting to improve the safety and effectiveness of tried and true CT through local delivery.
Novan Announces Promising Clinical Results With SB414
Novan, Inc. recently announced an update on the SB414 nitric oxide-releasing cream product candidate and its application to two therapeutic indications: atopic dermatitis and psoriasis.…
Immunocore Announces Start of Phase I ImmTAC Study in Patients with Solid Tumors
Immunocore Limited recently announced it has dosed the first patient in a Phase I study, part of an ongoing collaboration with GlaxoSmithKline (GSK). The study,…
RedHill Biopharma Receives Allowance for New US Patent Covering Encapsulated Bowel Preparation
RedHill Biopharma Ltd. recently announced it has received a Notice of Allowance from the US Patent and Trademark Office (USPTO) for a new formulation patent…
Q BioMed Announces FDA Filing for Strontium Chloride Sr89 Injection USP for Relief of Metastatic Cancer Bone Pain
Q BioMed Inc. and BioNucleonics recently announced submission of a supplemental regulatory filing to the FDA for the approval of a new manufacturing facility. Once…
Evotec & Novo Nordisk Form Strategic Research Alliance
Evotec AG recently announced a strategic alliance with Novo Nordisk to discover and develop novel small molecule therapies to treat patients suffering from diabetes and…
CCAB Partners With ImmunoBiochem as it Launches New Co-Development Strategy to Advance Early-Stage Biotech Companies
The Centre for the Commercialization of Antibodies and Biologics (CCAB) and ImmunoBiochem Corporation have announced an agreement that will see CCAB provide a new investment to help advance ImmunoBiochem’s novel breast cancer therapeutic candidate one step closer to the clinic.
Rexahn Pharmaceuticals Announces Clinical Collaboration With Merck
Rexahn Pharmaceuticals, Inc. recently announced it has entered into a clinical trial collaboration agreement with Merck (known as MSD outside the United States and Canada) to evaluate the combination of Rexahn’s RX-5902 and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in a Phase 2 trial in patients with metastatic triple negative breast cancer (TNBC).
Pfizer & Astellas Amend Clinical Research Protocols for Two Phase 3 Trials
Pfizer Inc. and Astellas Pharma Inc. recently announced amendments to the protocols for two registrational Phase 3 trials, ARCHES and EMBARK, designed to evaluate the safety and efficacy of XTANDI (enzalutamide) in men with hormone-sensitive prostate cancer (HSPC).
Orchard Therapeutics Announces $150-Million Financing to Advance Pipeline
Orchard Therapeutics recently announced the completion of an oversubscribed $150 million Series C financing. Deerfield Management led the financing with significant new investments from RA…
Stemline Therapeutics Announces FDA Accepts ELZONRIS BLA & Grants Priority Review
Stemline Therapeutics, Inc. recently announced US FDA has accepted for filing the company’s Biologics License Application (BLA) for ELZONRIS (tagraxofusp; SL-401) for the treatment of…
MeiraGTx Announces AAV-CNGA3 Has Received Orphan Drug Designation
MeiraGTx Holdings Plc recently announced that the US FDA has granted orphan drug designation (ODD) for its AAV-CNGA3 gene therapy product candidate for the treatment…
Mustang Bio & St. Jude Children’s Research Hospital Enter Exclusive Worldwide License Agreement
Mustang Bio, Inc. and St. Jude Children’s Research Hospital recently announced they have partnered and entered into an exclusive worldwide license agreement for the development…
CytoDyn Announces Strong Preclinical Results Using PRO 140 in Human Colon Carcinoma
CytoDyn Inc. recently announced that PRO 140 (leronlimab) has been shown effective at inhibiting the growth of a human colon carcinoma cell line (SW480) in…
