Formulation and Drug Delivery

Tezepelumab, being developed by AstraZeneca in collaboration with Amgen, reduced asthma exacerbations in Phase II and III clinical trials.

An additional batch of the Janssen COVID-19 vaccine has been authorized by FDA under the Emergency Use Authorization.

The rise of COVID variants has made public health officials anxious to expand immunity more widely and quickly in areas with low vaccination rates, and experts hope that full approval of existing and new vaccines will increase public confidence in their value.

The purpose of this research was to formulate modified liquisolid compacts (MLSC) of RLX for improved dissolution in immediate-release tablet formulations.

Advances in technology are accelerating the development and manufacture of subunit vaccines, an established class of vaccines.

Bi-layer tablets are an under-utilized option that can be employed to help reduce treatment burden, but their formulation is more complex than for conventional monolayer products.

Particle performance in a DPI can be optimized by fine-tuning the formulation and manufacturing process parameters.

CMOs and CDMOs adjust business processes as demand for COVID-19 treatments and non-pandemic related therapies puts pressure on the bio/pharma industry.

Vaccines define the path to putting the pandemic in the rear-view mirror.

Modified-release dosage forms present new opportunities for drug developers and can help overcome challenges, such as short biological half-life or poor bioavailability due to degradation in the stomach.

Pharmapack Europe event organizers have revealed increased levels of innovation in drug delivery across the industry, substantiated by the level of regulatory approvals.

Reports of myocarditis and pericarditis following Pfizer-BioNTech and Moderna vaccinations prompts warnings.

The European Commission has purchased an additional 150 million doses of Moderna’s COVID-19 vaccine for delivery in 2022.

EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.

CureVac’s first-generation COVID-19 vaccine candidate, CvnCoV, did not meet efficacy targets in a second interim analysis.

Recent analysis has shown that two doses of COVID-19 vaccines are highly effective against hospitalization as a result of infection with the Delta variant of COVID-19.

Sanofi’s new Pennsylvania facility expands production of Fluzone High-Dose Quadrivalent flu vaccine.

Evonik and Stanford University have signed a research collaboration to develop and market a new drug delivery platform for mRNA and gene therapy.

Novavax’s COVID-19 vaccine is 90.4% effective and maintains efficacy when administered with an influenza vaccine.

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.

Researchers from the Chalmers University of Technology and AstraZeneca have developed a new method of detecting and testing lipid nanoparticles.

New features of Syntegon’s GKF 60 capsule filler include a piezo dosing system, an Automated Process Development tool, and quick changeover to containment.

The vaccine is now authorized for ages 12 and older in European Union member states and the UK.

AGC Biologics has partnered with BioNTech to further supply plasmid DNA starting material from its Heidelberg, Germany, facility for the Pfizer-BioNTech COVID-19 vaccine.

FDA has granted accelerated approval to Biogen for Aduhelm (aducanumab), a new mAb treatment for Alzheimer’ disease.

MedPharm’s new facility for process development and small-scale manufacturing is in North Carolina, near its existing R&D center.

Aptamer Group and PinotBio have formed a strategic collaboration aimed at the development of new drug conjugates for targeted drug delivery.

Celltrion Healthcare has revealed positive one-year results from a Phase III trial comparing biosimilar adalimumab, Yuflyma, with the reference adalimumab in patients with rheumatoid arthritis.

The emergence of new biotherapeutics is both the driver and result of innovative drug development technologies.

In the present investigation, the fixed-dose combination (FDC) tablet of Atorvastatin calcium and Ezetimibe was prepared by a quality-by-design approach using two-level factorial design.