Formulation Development
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….
Servier & X-Chem Announce Drug Discovery Collaboration
Servier and X-Chem, Inc. recently announced a partnership to identify and develop novel small molecules for the treatment of….
Kite & Oxford BioTherapeutics Establish Cell Therapy Research Collaboration
Kite, a Gilead Company, and Oxford BioTherapeutics Ltd. recently announced the companies have entered into a research collaboration to evaluate five novel targets for a….
Argenx & Zai Lab Announce Strategic Collaboration
Argenx SE and Zai Lab Limited recently announced an exclusive license agreement for the development and commercialization of efgartigimod in Greater China, including….
Catalyst Pharmaceuticals Announces Strategic Plan for Product Portfolio Expansion
Catalyst Pharmaceuticals, Inc. recently announced an expansion in its strategic priorities related to portfolio planning and research and development. Catalyst also provided preliminary net revenues…
WuXi STA’s Integrated CMC Platform Supports InnoCare Orelabrutinib Approved by NMPA
STA Pharmaceutical, a WuXi AppTec Company (WuXi STA), recently announced their partner Innocare has received approval by the National Medical Products Administration of China (NMPA)…
Silo Pharma Inc. Receives $1 Million in Up Front Licensing Deal
Silo Pharma, Inc. recently announced it has entered into an agreement to license technology covered by provisional patent applications filed by Silo Pharma with the…
EMA Recommends COVID-19 Vaccine Moderna for Authorization in the EU
The EMA has recently recommended granting a conditional marketing authorization for COVID-19 Vaccine Moderna to prevent coronavirus disease 2019 (COVID-19) in people from 18 years…
Apollomics & GlycoMimetics Granted Breakthrough Therapy Designation
Apollomics, Inc. and GlycoMimetics recently announced APL-106 (uproleselan) has been granted Breakthrough Therapy Designation (BTD) from the China National Medical Products Administration (NMPA) Center for…
