Formulation Development
Ritter Pharmaceuticals Selects Medpace as its CRO for Pivotal Phase 3 Trial
Ritter Pharmaceuticals, Inc. recently announced it has signed an agreement with the clinical research organization (CRO) Medpace to conduct the first of two pivotal Phase 3 clinical trials for RP-G28 in patients with lactose intolerance (LI).
Amerigen & Dipharma Announce Approval of First Generic of Miglustat
Amerigen Pharmaceuticals Limited and Dipharma S.A. recently announced that Amerigen’s Abbreviated New Drug Application (ANDA) for Miglustat 100 mg capsules has received final approval from the US Food and Drug Administration.
Syndax & Nektar Therapeutics Announce Immuno-Oncology Clinical Trial Collaboration
Syndax Pharmaceuticals, Inc and Nektar Therapeutics recently announced a non-exclusive, clinical collaboration to evaluate the safety and efficacy of Nektar’s NKTR-214, a CD122-biased agonist, in combination with entinostat, Syndax’s oral, small molecule Class 1 specific HDAC inhibitor, in patients with metastatic melanoma who have previously progressed on treatment with an anti-PD-1 (programmed death receptor-1) agent.
TxCell Names Lonza as its CAR-Treg Cellular Product Manufacturer
TxCell SA and Lonza Pharma & Biotech recently announced entering into a Master Service Agreement for the manufacture of TxCell’s HLA-A2 CAR-Treg cellular product (TX200), which is in development for the prevention of chronic rejection after organ transplantation.
Ajinomoto Althea, Inc. Announces Additions to Management Team as it Transforms Into a Global CDMO
We are excited to welcome both Darwin and Bert to our leadership team at Althea,” said J. David Enloe, Jr., President and CEO of Althea. “Between them, they bring more than 60 years of commitment to manufacturing excellence, product quality and improving patients’ lives.
NEOMED-LABS Renews Strategic Agreement With GSK
Laval headquartered NEOMED-LABS, a global leader in the clinical immunology field, recently announced a 3-year extension of their strategic agreement with GSK, the world’s largest vaccine manufacturer.
AIT Therapeutics Presented Data From Inhaled Nitric Oxide Study
AIT Therapeutics, Inc. recently announced the results of its study titled Nitric Oxide Inhalations in CF Patients Infected with Mycobacterium Abscessus Complex: A Prospective, Open-Labeled Multi-Center Pilot Study at the 2018 American Thoracic Society (ATS) Conference in San Diego, CA.
Pharma 4.0 – A New Initiative to Help Design the Pharma Facility of the Future
The pharma industry is continuously evolving which creates value for both the industry itself and the patients that rely on the ever-more varied and targeted drugs it manufacturers. An initiative that is strongly reflective of this evolution and one actively affecting the industry itself is Pharma 4.0.
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.
GLOBAL REPORT - 2017 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery & Formulation Pipeline
In the final installment of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, provides a pipeline review and analysis (centered on drug delivery and formulation products) looking forward and back 5 years for a total of 10 years.
ANTIBODY DISCOVERY - Why Understanding Immune Dysregulation is the Key to Drug Development
David S. Johnson, PhD, provides a unique insight into immune dysregulation through a proprietary technology known as Surge – a platform that quickly characterizes every cell in complex immune systems so that natural immune repertoires can be translated into medical treatments.
PEPTIDE DELIVERY - The Endometriosis Enigma – Why Can't There Be a Pill for That?
Joel Tune, MBA, says for those peptide therapeutics that meet the necessary criteria, advances in formulation technologies coupled with favorable market dynamics will continue to drive interest across the entire prescription drug spectrum for safe and effective orally administered peptide therapeutics.
MICROFLUIDICS - Taking a Microfluidics Approach to Drug Delivery
Richard Gray, MA, and Pavel Abdulkin, PhD, look at how microfluidics is changing the drug development sector and explore an exciting new non-encapsulating microparticle-based approach that offers “tunable” release of the API.
PERSONALIZED IMMUNOTHERAPY - Off-the-Shelf Personalized Immunotherapy for Breast Cancer: The BriaCell Solution
William V. Williams, MD, Markus Lacher, PhD, and Charles L. Wiseman, MD, explain how there is a clear need for ways to stimulate effective cancer-specific immune responses while avoiding time-consuming and costly individualized manufacturing.
THERAPEUTIC FOCUS - Antisense Drug Shown to Significantly Reduce Triglyceride Levels in Patients With Severe Hypertriglyceridemia
Ioanna Gouni-Berthold, MD, provides results from a clinical study indicating antisense technology can result in significant reductions in triglyceride levels in patients with hypertriglyceridemia.
MULTIPARTICULATE SYSTEM - Advances in Lipid Multiparticulate Technologies for Controlled Release
Jaspreet Arora, PhD, Samantha Saville, and Brett Waybrant, PhD, focus on a controlled-release LMP formulation to identify optimum annealing conditions and to better understand the annealing mechanism.
SPECIAL FEATURE - Prefilled Syringes & Parenteral Manufacturing: Drug & Packaging Ensure Safety, Compatibility & Stability
Contributor Cindy H. Dubin highlights some of the key players in the market and where they are focusing their efforts to ensure products are of the highest quality, safe, and easy to use.
EXECUTIVE INTERVIEW - Singota Solutions: Keeping Up With Trends & Technology as a CDMO
Brent Lieffers, Senior Director of Operations, discusses the need for keeping up with trends and technology as an innovative CDMO.
GLOBAL REPORT - 2017 Global Drug Delivery & Formulation Report: Part 3, Notable Transactions & Technologies of 2017
In part 3 of this 4-part series, PharmaCircle in collaboration with Drug Development & Delivery, reviews transactions and technologies that provide greater insight into what we can expect in terms of product development and approvals over the next decade.
SOLID FORM SCREENING - Phase Appropriate Strategies for Solid Form Discovery & Development
Pingyun Chen, PhD, describes a rational, fit-for-purpose strategy for solid form screening and selection to ensure a successful yet cost-effective progression of drug candidates from discovery, clinical trials, and commercialization.
