Formulation Development
Quantum Genomics Launches Phase 3 Pivotal REFRESH Study
Quantum Genomics recently announced the launch of its Phase 3 REFRESH study in difficult-to-treat or resistant hypertension. This new study is part of firibastat’s Phase…
Gritstone Advances Second-Generation COVID-19 Vaccine
Gritstone Oncology, Inc. recently announced it is advancing development of a second-generation vaccine against SARS-CoV-2, the virus that causes COVID-19, with potential for both prolonged…
Caladrius Biosciences Treats First Patient in the Phase 2b FREEDOM Trial
Caladrius Biosciences, Inc. recently announced it has treated the first patient in its Phase 2b FREEDOM trial of CLBS16 as a therapy for coronary microvascular…
Hovione Launches the Most Advanced Screening Service for Optimal Spray Dried Dispersions Formulation
Hovione, the leader in Pharmaceutical Spray Drying, recently announced the launch of ASD-HIPROS, a proprietary screening service for spray dried dispersions…..
BD Advances Immunology Research by Enabling Researchers to Investigate 30 Immune Markers in a Single Experiment
BD (Becton, Dickinson and Company) recently announced the commercial release of the BD AbSeq Immune Discovery Panel (IDP), a state-of-the-art, pre-titrated antibody-oligo-based discovery tool designed to….
AMRI Included in BARDA CDMO Network in Support of COVID-19 Pandemic Response in the US
Albany Molecular Research, Inc. recently announced its Albuquerque, NM, facility has been approved for inclusion in the Biomedical Advanced Research and Development Authority (BARDA) contract…
Catalent Agrees to Acquire Dry Powder Inhaler Spray Drying, Capsule Manufacturing & Packaging Capabilities From Acorda Therapeutics
Catalent recently announced it has entered into a definitive agreement to acquire the manufacturing and packaging operations of Acorda Therapeutics, Inc. The acquisition complements Catalent’s…
Seer Signs Commercial Agreement to Provide Complete End-to-End Solution for Unbiased, Deep, Rapid & Large-Scale Proteomics
Seer recently announced it has signed a non-exclusive commercial agreement with Thermo Fisher Scientific for Seer to offer Thermo Fisher’s Orbitrap Eclipse Tribid and Orbitrap…
First Patient Dosed in Pilot Study for Acute Musculoskeletal Pain
Vitalis LLC recently announced the dosing of the first patient in a pilot study evaluating safety and preliminary analgesic efficacy of VTS-K in patients with…
DalCor Announces Launch of Dalcetrapib Clinical Trial for COVID-19
DalCor Pharmaceuticals recently announced the initiation of dal-COVID, a Phase 2 proof-of-concept study for dalcetrapib as a potential oral anti-viral treatment for COVID-19. The main…
Cara Initiates Phase 2 Trial of Oral Treatment for Pruritus in Patients with Notalgia Paresthetica
Cara Therapeutics, Inc. recently announced the initiation of a Phase 2 trial of Oral KORSUVA (difelikefalin) for the treatment of moderate-to-severe pruritus in patients suffering…
SPECIAL FEATURE - Outsourcing Analytical Testing: Innovative Drugs Spike Demand for Advanced Analysis
Contributor Cindy H. Dubin asked some of the key analytical testing providers to describe their offerings in several key areas and what advanced analytical testing techniques they can offer to pharma clients.
FORMULATION FORUM - Oral Controlled Delivery of Poorly Water-Soluble Drugs
Jim Huang, PhD, discusses how understanding key biopharmaceutical properties in relationship to drug absorption and elimination plays a critical role in successful design of CR dosage forms from discovery to first-in-human with a shorter timeline and lower development costs.
TUB PACKAGING - Why Double-Bagged Tubs Are an Issue for High-Speed Filling
Tilman Roedle says variation in tub packaging continues to create financial and operational challenges for the entire downstream supply chain, and it’s time for the industry to align on packaging configuration requirements that make tubs fully processable on automated lines.
MULTI-PARTICULATE MANUFACTURING - How Does Experiment Design Affect Multi-Particulates Manufacturing?
Namrata Vora, MS, Danica Cartwright, Karthikeyan Selvaraj, MPharm, and Ryan Larmon, MS, discuss how the careful application of design of experiment studies is an invaluable tool in proving the design space of complex formulations and manufacturing processes.
EXECUTIVE INTERVIEW - BiologIC Technologies: The Future Microsoft for the Biorevolution
Richard Vellacott, CEO of BiologIC Technologies, discusses his company’s unique technology and its applications in the future of medicine and wider fields of synthetic biology.
FORMULATION DEVELOPMENT - The Role of Excipient Selection in the Development of Orally Disintegrating Tablets
Torkel Gren, PhD, reviews the benefits that orally disintegrating products can bring to patients and developers and assesses the impact that excipient selection can have on the development of successful products.
EXECUTIVE INTERVIEW - Fortress Biotech, Inc.: Looking for the Muffin Tops
Lindsay A. Rosenwald, MD, Chairman, President, and CEO of Fortress Biotech, discusses how his medical and financial knowledge come together to find successful drug candidates, the company’s partnership model, and the inefficiencies he sees in the biotech industry.
BIOSIMILAR DEVELOPMENT - Biosimilars: The Process & Quality System Approach to Clinical Applications
Kaiser Aziz, PhD, addresses biosimilar developments and future innovations with an emphasis placed on quality system approaches to the development and availability of new biosimilar products.
SIRION Biotech GmbH Licensed LentiBOOST™ Transduction Technology to Cellectis
Through this recent license agreement, SIRION Biotech GmbH has granted Cellectis non-exclusive right under its proprietary lentiviral transduction….