Formulation Development
DRUG DISCOVERY - Validated Phenotypic Approach to Neuropsychiatric Drug Discovery
Emer Leahy, PhD, reviews how the SmartCube platform represents a novel approach to discovering the next generation of breakthrough treatments for schizophrenia and other neuropsychiatric disorders.
ARTIFICIAL INTELLIGENCE - Practical Applications of Artificial Intelligence (AI) for Drug Data Quality & Research
Robert Stanley believes by treating AI as one more tool within a broad data quality toolkit, and by focusing narrowly on specific research and business bottlenecks, it is possible to efficiently bring real practical benefits to research and business.
MULTIPARTICULATE FORMULATIONS - Using Multiparticulate Technology to Develop Pediatric Drug Products
Sven Stegemann, PhD, Matt Shaffer, Samantha Saville, and Jaspreet Arora, PhD, believe as pediatric formulations are expected to continue as a core research area in pharmaceutical technology, MP technologies have the potential to play a key role.
NANOPARTICLE DELIVERY - Ultra-Small Particles Offer Big Hope in Cancer Theranostics
Kai Ma, PhD, Ulrich Wiesner, and Michelle Bradbury, MD, PhD, believe ultra-small sub-10 nm particles hold unique properties and represent an emerging area of investigation for biomedical applications.
EXECUTIVE INTERVIEW - SK life science: Challenges of Developing Therapies for Neurological Diseases
Sebby Borriello, Vice President & Chief Commercial Officer, speaks about the challenges and trends surrounding development of therapies for neurological diseases.
FORMULATION FORUM - Formulation Research Strategy for Discovery-Stage New Drug Candidates
Jim Huang, PhD, and Edward Orton, PhD, say it is critically important CROs or CDMOs that support discovery and preclinical research have the requisite preformulation, formulation, and biopharmaceutics expertise as well as the proprietary methodologies to develop formulations from small quantities of drug candidates for different routes of administration.
SGS Appoints Biologics Manager at Expanded Life Sciences Facility in Illinois
SGS, a leading bio/pharmaceutical analytical and bioanalytical contract solutions provider, today announced the appointment of Dr. Haris Jamil as Biologics Manager of its recently expanded biopharmaceutical testing facility in Lincolnshire, Illinois, USA.
CHARACTERIZATION CORNER - From Dilute Sample to Clinically Representative Formulation: Analyzing the Higher Order Structure of mAbs Over a Wide Dynamic Range
Jeff Zonderman explains how the characterization of mAbs at high concentration in clinically representative formulations, without the need for dilution or concern for interference from a formulation buffer’s excipient, is vital.
Sarepta Therapeutics Announces Positive & Robust Expression & Biomarker Data
Sarepta Therapeutics, Inc. recently announced positive results from three Limb-girdle muscular dystrophy (LGMD) Type 2E clinical trial participants who received MYO-101. MYO-101 is a novel…
Foamix Announces Positive Results From Phase 3 Open-Label Safety Study Evaluating Topical Minocycline Foam
Foamix Pharmaceuticals Ltd. recently announced positive safety and efficacy data for its Phase 3 open-label safety study (FX2016-13), evaluating FMX103 in moderate-to-severe papulopustular rosacea for…
ABclonal Technology Partners With BenchSci to Boost Discoverability of its Novel Products
ABclonal Technology and BenchSci have recently entered into a partnership to provide scientists with high-class research tools for accelerating biomedical discoveries. Research scientists have always…
Cellectar Reports Positive Top-line Response Rate of 30% from R/R Multiple Myeloma Cohort in Ongoing Phase 2 Study
Cellectar Biosciences, Inc. recently announced additional positive top-line results from its ongoing Phase 2 clinical study of CLR 131, the company’s lead product candidate. In…
Nuvec: A Breakthrough Technology for mRNA/pDNA Delivery for Vaccines & Cancer Treatments
N4 Pharma Plc, a specialist pharmaceutical company, is developing Nuvec – a unique non-viral adjuvant delivery system for vaccines and cancer treatments. This silica nanoparticle…
Rockland Immunochemicals & Cellaria Sign Worldwide Distribution Agreement
Cellaria, LLC recently announced a new distribution partnership with Rockland Immunochemicals, Inc. (Rockland) that gives Rockland the rights to market and sell Cellaria’s high-quality next generation in-vitro disease models and cell culture media worldwide.
AKCEA-APO(a)-LRx Advances as Novartis Exercises Option to License
Akcea Therapeutics, Inc. recently announced that Novartis has exercised its option to license AKCEA-APO(a)-LRx, a drug to treat patients with elevated levels of lipoprotein(a), or Lp(a), and established cardiovascular disease (CVD).
U.S. FDA Grants Breakthrough Therapy Designation to Amicus Therapeutics
Amicus Therapeutics recently announced that the US FDA has granted to Amicus a Breakthrough Therapy Designation (BTD) to AT-GAA for the treatment of late onset Pompe disease, an inherited lysosomal storage disorder caused by the deficiency of an enzyme known as acid alpha-glucosidase (GAA).
BrainStorm Announces First Contracted US Clinical Site for Phase 2 Progressive MS Study
BrainStorm Cell Therapeutics Inc. recently announced Cleveland Clinic as the first US clinical site contracted for a planned Phase 2 open-label, multicenter study of repeated…
ARCA Biopharma Announces FDA Agreement for a Single Phase 3 Clinical Trial
ARCA biopharma, Inc. recently announced it has reached agreement with the US FDA regarding a Special Protocol Assessment (SPA) on the design of a pivotal…
Sapreme Technologies to Develop an Oligonucleotide Delivery Platform
Sapreme Technologies has been awarded a $7.71 million grant together with a multidisciplinary consortium including 11 other academic and industrial parties.
Moleculin Announces Out-Licensing Deal to Accelerate Preclinical & Clinical Development
Moleculin Biotech, Inc. recently announced it has entered into a sub-license agreement with WPD Pharmaceuticals (WPD), located in Poland.
