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.
SMART DEVICES – Add-On Connectivity Facilitates New Generation of Smart Inhalers
Contributor Cindy H. Dubin reviews how the addition of electronic and connectivity to inhalers may improve patient adherence and, consequently, treatment efficacy.
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.
EXECUTIVE INTERVIEW – PCI Synthesis: Acquisition by Seqens Expands its Pharmaceutical Offerings
Ed Price, President and CEO of PCI Synthesis, reflects on the trends fostering the CDMO industry consolidation and the positive impact it augurs in addressing sponsors’ needs to enter the clinic more quickly and safely.
DRUG DEVELOPMENT – Rapid Preparation of Gadolinium & Protamine Complexes With Aurintricarboxylic Polysalicylates: Implications for Drug Development
Timothy J. Smith, RPh, PhD, reviews how derivatives of aurintricarboxylic acid (ATA), a commercial reagent for aluminum ion determination, are under consideration for drug development in view of ATA’s diverse pharmacological spectrum.
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.
REAL ESTATE – Four Ways Firms Are Advancing Innovation With Real Estate
Roger Humphrey, MBA, says as companies pursue various and unique collaborative platforms, their real estate needs are changing — with profound implications for how and where life sciences companies choose to operate.
RISK MANAGEMENT – FDA’s Quality Risk Management Approach to New Drug Applications
Kaiser J. Aziz, PhD, explains how the FDA emphasizes the Quality Risk Management approach to design of studies by providing oversight and objective review of risk-benefit analysis that guides the use of new drug products by providing patients organized data and appropriate labeling information in support of the new drug’s intended clinical use.
SPECIAL FEATURE – Improving Bioavailability & Solubility: Chemical & Physical Modification vs. Formulation Development
Contributor Cindy H. Dubin speaks with several leading companies to explore chemical and physical modification versus formulation development, and new technologies and techniques for improving bioavailability and solubility.
EXCLUSIVE ONLINE CONTENT
QPS Outpaces Market Growth for Phase I Clinical Trials
QPS, a global contract research organization (CRO) providing discovery, preclinical, and clinical drug development services, recently announced its successful implementation of ClinSpark, an eSource technology…
Autolus Therapeutics Receives FDA Orphan Drug Designation
Autolus Therapeutics plc recently announced the US FDA has granted orphan drug designation to autologous enriched T-cells genetically modified with a retroviral vector to express…
Cambrex Completes New Quality Control Laboratory for Generic API Development in Milan
Cambrex Corporation (NYSE: CBM), the leading small molecule company providing drug substance, drug product and analytical services across the entire drug lifecycle, today announced that…
Soligenix Achieves Significant Enrollment Milestone for its Pivotal Phase 3 Clinical Trial
Soligenix, Inc. recently announced today it has reached a significant milestone in the Phase 3 clinical study (the “DOM-INNATE” study) for SGX942 (dusquetide) in the treatment of oral mucositis in patients with head and neck cancer (HNC).
Hovione Technology Announces Acquisition of Global Rights to New Pulmonary Inhaler Device
Hovione Technology, a specialist in development of innovative inhalation device technology, recently announced it has secured global rights to develop and commercialize a new ultra-affordable, multi-use blister-based dry powder inhaler patented by inventor Dr. Klaus-Dieter Beller.
Paragon Bioservices to be Acquired for $1.2 Billion
Catalent, Inc. and Paragon Bioservices, Inc. and Catalent Inc. recently announced they have entered into a definitive agreement under which Catalent will acquire Paragon for $1.2 billion.
BioAtla & BeiGene Form Worldwide Development & Commercialization Collaboration
BioAtla , LLC and BeiGene, Ltd. recently announced the two companies have entered into a global co-development and collaboration agreement for the development, manufacturing, and commercialization of BioAtla’s investigational CAB CTLA-4 antibody (BA3071).
GeneDesign Joins Ajinomoto Bio-Pharma Services & Opens Oligonucleotide API Development Center
Ajinomoto Bio-Pharma Services, a leading provider of biopharmaceutical contract development and manufacturing services, recently announced that GeneDesign, Inc. has joined the global organization.
Industry Trends: Vigilance is Critical for Future Success
Peter Soelkner says there will always be a wide variety of trends influencing our industry and we see no reason why this will not continue well into the future.
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.
MARKET NEWS & TRENDS
ExCellThera’s Lead Technology Receives FDA Regenerative Medicine Advanced Therapy Designation
OmniSeq & LabCorp Extend Exclusive Distribution Pact & Complete Follow-On Investment Agreement
