Degenhard Marx, PhD, and Günter Nadler discuss the treatment of sore throats via a pump spray and explore the considerations to be made when developing a reliable spray product.
GLOBAL REPORT – 2017 Global Drug Delivery & Formulation Report: Part 2, Notable Product Approvals of 2017
In part 2 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, reviews the more interesting individual products approved throughout the past year.
Gregory A. Sacha, PhD, introduces the common equipment available for automated inspection and discusses inspection testing methods for prefilled syringes.
MONOCLONAL ANTIBODIES – The Development of Therapeutic Monoclonal Antibody Products: A Comprehensive Guide to CMC Activities From Clone to Clinic
Howard L. Levine, PhD, and Brendan R. Cooney, provide a guide to product development companies, service providers, investors, and analyst as they work their way through the complex and rapidly evolving world of therapeutic monoclonal antibodies.
ORALLY INHALED PRODUCTS – Optimizing the Application of In Vitro Test Methods for the Demonstration of Bioequivalence in Orally Inhaled Products
Mark Copley, MEng, and Anna Sipitanou, MSc, examine the testing strategies demonstrating the BE of OIPs, their relevance, and the submission approaches outlined by the FDA and EMA.
EXECUTIVE INTERVIEW – MilliporeSigma: Accelerating the Development & Manufacture of Gene Therapies, Immunotherapies & Viral Vaccines
Dave Backer, Head of Virus & Gene Therapy Strategic Initiatives at MilliporeSigma, talks about his company’s expanding GMP capacity to speed development and manufacture of gene therapies, immunotherapies, and viral vaccines.
Kalina Ranguelova, PhD, demonstrates how the latest digital and microwave technologies in benchtop EPR instrumentation is giving researchers new insight into ROS and free radicals that may shape the future development of more effective treatments of disease.
Contributor Cindy H. Dubin highlights the techniques various excipient manufacturers are using to develop more innovative and effective ingredients to improve the performance of drug molecules.
Contributor Cindy H. Dubin explores 3D printed drugs in the wake of a milestone in the pharma industry when Aprecia Pharmaceuticals’ Spritam (levetiracetam) tablets became the first FDA-approved prescription drug product manufactured using 3D printing technology.
Peter Nielsen, MBA, explains how his company’s candidates are differentiated from those in development at other companies by the type of modification to the antisense molecule and the method by which it is conveyed to its target cell.
EXCLUSIVE ONLINE CONTENT
Thermo Fisher Scientific Inc. recently announced its intent to open multiple Global Customer Solution Centers. The new Global Customer Solution Centers will focus on meeting and exceeding the demands of scientists in food, beverage, pharmaceutical and biotech laboratories by developing critical workflows and integrated solutions that help advance chromatography and mass spectrometry worldwide.
Molecular Templates Announces Agreement With Takeda for Joint Development of Protein-Based Oncology Therapy
Molecular Templates, Inc. recently announced an agreement with Takeda Pharmaceutical Company Limited for the joint development of CD38-targeted engineered toxin bodies (ETBs) for the treatment of patients with diseases such as multiple myeloma.
Evonik Completes Multi-Million Dollar Expansion of its CMO Capabilities for API & Advanced Intermediates
Evonik, a global CMO leader for API and advanced intermediates, recently announced the completion of a €36-million expansion of its contract manufacturing capabilities in the US and Europe.
VistaGen Therapeutics, Inc. and Pherin Pharmaceuticals, Inc. recently announced the signing of a license agreement granting VistaGen exclusive worldwide rights to develop and commercialize PH94B nasal spray, a Phase 3-ready drug candidate for as-needed (PRN) treatment of Social Anxiety Disorder (SAD).
Biothera Pharmaceuticals, Inc. recently announced a clinical collaboration with AstraZeneca to evaluate whether the combination of Biothera’s Imprime PGG and AstraZeneca’s durvalumab (IMFINZI) can decrease tumor volume in patients with primary untreated locally advanced head and neck cancer prior to surgical resection.