Respiratory Drug Development eBook – Inhaled Medications for Treating Unconventional Respiratory Diseases
This second annual Drug Development & Delivery Respiratory eBook focuses on a few companies that are taking inhalation devices to a new level in drug delivery.
THERAPEUTIC FOCUS – The Future of Treating Alzheimer’s Disease: Aducanumab & Beyond
Hermann Russ, MD, PhD, and Alexander Gebauer, MD, PhD, believe the times when amyloid beta as a drug target have been dubbed a dead horse in the race for treatment of Alzheimer’s disease are now over.
SPECIAL FEATURE – Outsourcing Formulation Development & Manufacturing: Specialized Capabilities for Small & Large Molecules
Contributor Cindy H. Dubin interviews key players in the CDMO market who present case studies about how they are helping pharmaceutical and biopharma companies overcome a variety of formulation and manufacturing challenges.
PFS MANUFACTURING – Prefilled Syringes & Biologics: The Perfect Partnership of Medicine & Delivery
Anish Parikh charts the twin rise of biologics and PFS, outlines some of the common challenges associated with filling and dispensing, and discusses how a patient-centric partnership approach can help biopharmaceutical companies shorten the development pathway and ensure a reliable supply of safe, effective medicines for the people who need them.
GENE THERAPY – The Role Viral Vectors Play in Current Gene Therapy Development
Dieter Lingelbach, MBA, discusses the history and science of viral vectors, their current applications, and why they are a vital component in contemporary gene therapy development.
FORMULATION FORUM – Application of Captisol® Technology to Enable the Formulation of Remdesivir in Treating COVID-19
James Pipkin, PhD, Vince Antle, PhD, and Rebecca Garcia-Fandiño, PhD, explain why more Captisol® than ever is required to meet Gilead’s bold goals of making remdesivir available to COVID-19 patients in the US and to hundreds of countries around the world.
FORMULATION DEVELOPMENT – Formulating Immediate-Release Tablets for Poorly Soluble Drugs
Gayatri Khanvilkar, MPharm, Ajit Bhagat, Sangmesh Torne, PhD, Tejas Gunjikar, PhD, and Amina Faham, PhD, present a case study showing that previously unviable APIs can be successfully processed with the right methods, which should give hope to formulators facing similar difficulties.
CHIMERIC COMPOUNDS – “Dopastatins”: One Molecule Targeting Two Receptors for the Treatment of Pituitary Tumors
Heather Halem, PhD, and Michael D. Culler, PhD, believe this novel class of compounds represents a potential treatment for neuroendocrine tumors that are vulnerable to the synergistic dual activation of somatostatin and dopamine receptors.
NEXT-GENERATION TUMOR TARGETING – Leveraging the Tumor Microenvironment to Change the Standard of Care
Vishwas Paralkar, PhD, highlights a unique platform technology that represents the first technology that has successfully been used to target cancer drugs to tumor cells in animal models, while sparing healthy tissue.
FORMULATION FORUM – Rational Design of Oral Nanosuspensions for Insoluble Drugs
Jim Huang, PhD, explains how nanosuspensions are an important class of pharmaceutical dosage forms, particularly for pharmaceutical compounds with solubility and bioavailability challenges.
EXECUTIVE INTERVIEW – Adare Pharmaceuticals: A Virtual Acquisition is Possible
Ajay Damani, VP of Pharmaceutical Technologies Business Unit, Adare, and Maria Flynn, President and CEO, Orbis, discuss how both companies will benefit from the acquisition, future product development, and the challenges of a virtual acquisition.
GLOBAL REPORT – 2019 Global Drug Delivery & Formulation Report: Part 4, The Drug Delivery and Formulation Pipeline
In part 4 of this 4-part series, PharmaCircle, in collaboration with Drug Development & Delivery, analyzes the pipeline with an emphasis on clinical-stage products for which there is more product-related information.
SPECIAL FEATURE – Prefilled Syringes & Parenteral Manufacturing: Innovations, Challenges & Solutions
Contributor Cindy H. Dubin features several leading companies’ innovations in delivery devices as well as how contract parenteral manufacturers are addressing the ever-demanding challenges, issues, and opportunities related to delivering biologics and small molecules.
SUPPLY CHAIN SOLUTIONS – Storage and Distribution Support for Clinical Trials Worldwide
Patient centricity has moved to the forefront of clinical trials. Direct-to-patient (DTP) services provide convenience, and lead to greater participation and retention, addressing two key challenges that face study sponsors Yourway has.
DRUG DISCOVERY – Disrupting Drug Discovery From Assay Development to Lead Compound
Zack Gurard-Levin, PhD, says with new innovations in assay methodologies, scientists no longer have to make sacrifices to do quality drug discovery research.
EXCLUSIVE ONLINE CONTENT
Scioto Biosciences Receives $26.5 Million Series B Investment From Genome & Company
Scioto Biosciences recently announced the closing of a strategic investment of up to $26.5 million from Genome & Company and other investors to join in an upcoming tranche….
Protalix BioTherapeutics & Chiesi Global Rare Diseases Announce US FDA Acceptance of Biologics License Application
Protalix BioTherapeutics, Inc. together with its development and commercialization partner Chiesi Global Rare Diseases recently announced the US FDA has accepted the Biologics License Application (BLA) and granted….
MyoKardia & LianBio Form Strategic Development & Commercialization Partnership
MyoKardia, Inc. and LianBio recently announced they have entered into a strategic collaboration to develop and commercialize….
GigaGen Announces Publication of Research Describing a New Class of Drugs, Recombinant Hyperimmunes, Including its Novel COVID-19 Therapy, GIGA-2050
GigaGen presents a novel technology for producing a new class of drug, which it calls recombinant hyperimmunes…..
Biogen & Denali Sign Co-Development/Co-Commercialization Agreement
Biogen Inc. and Denali Therapeutics Inc. recently announced they have signed a binding agreement to co-develop and co-commercialize Denali’s small molecule inhibitors of leucine-rich repeat kinase 2 (LRRK2) for….
RedHill Biopharma’s Phase 2/3 COVID-19 Study Approved in Mexico
RedHill Biopharma Ltd. recently announced approval from the Mexican Federal Committee for the Protection against Sanitary Risks (COFEPRIS) for the company’s Clinical Trial Authorization (CTA) application for….
Immatics Extends Cell Therapy Manufacturing Collaboration With UTHealth
Immatics N.V. recently announced the extension of its cell therapy manufacturing collaboration with The University of Texas Health Science Center at Houston (UTHealth)….
Catalent Adds Potent Manufacturing Capabilities at its Buenos Aires Site
Catalent recently announced that it will expand its Argentinian site in Loma Hermosa, Buenos Aires. The expansion, which will add over….
Editas Medicine Enters Into Strategic Partnership With Catalent to Support Gene-Editing Medicine Pipeline
Editas Medicine, Inc. and Catalent recently announced they have entered into a strategic partnership whereby Catalent will provide support for the development, manufacturing, and clinical supply of….
Arrowhead Pharmaceuticals Earns $20-Million Milestone Payment From Amgen
Arrowhead Pharmaceuticals Inc. recently announced it has earned a $20-million milestone payment from Amgen following the administration of the first dose of….
