Contributor Cindy H. Dubin reviews some of the innovative and novel technologies developers are deploying to make self-injection easier and improve patient adherence.
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.
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.
William Boomershine, PhD, explains how high-resolution mass spectrometry is a key component to the characterization of novel biologics and biosimilars.
Taras Seniuch, Director of Business Development at SHL’s contract manufacturing organization, SHL Pharma, talks about his company’s unique service offering for its partners.
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.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: CDMOs Are Innovating for 21st-Century Medicine
Contributor Cindy H. Dubin speaks with some of the industry’s leading CDMOs about the innovations they are developing for next-generation patient care, and how many are making investments that are enabling them to offer more services under one roof.
EXCLUSIVE ONLINE CONTENT
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).
PAREXEL Advances Patient-Centric Drug Development With Introduction of its Patient Innovation Center
PAREXEL International Corporation, a leading innovator of global biopharmaceutical services, today announced the launch of its Patient Innovation Center, designed to help guide sponsors in their efforts to improve efficiency and success across all areas of biopharmaceutical development including clinical trial design, recruitment, execution and market access.
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.
Metrion Biosciences Limited and AMRI recently announced they have signed a new collaboration agreement. The alliance will promote Metrion’s electrophysiology and ion channel screening expertise to global pharmaceutical and biotechnology clients.
CURE Pharmaceutical recently announced it entered into a multi-year licensing agreement for the first time with a leading international cannabis company.
Reata Pharmaceuticals, Inc. recently announced it has received a $30-million milestone payment from its licensee, Kyowa Hakko Kirin Co., Ltd. following the initiation of AYAME, a Phase 3 clinical trial to assess the efficacy and safety of bardoxolone methyl (bardoxolone) for the treatment of diabetic kidney disease in Japan.
SunGen Pharma recently announced it has entered into a Manufacturing Agreement with Grand River Aseptic Manufacturing (GRAM) to manufacture generic injectable pharmaceutical products.
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).
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.
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.