Formulation and Drug Delivery

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.

In addition to ADCs, other types of highly potent biologics require specialized manufacturing skills.

Particle engineering is a vital tool in overcoming many formulation challenges, and technological advances are enabling developers to achieve the full potential of pipeline molecules.

Moderna has initiated a rolling submission process with FDA for a biologics license application for its mRNA COVID-19 vaccine for individuals 18 years of age and older.

Bio/pharmaceutical manufacturers have made a good first step toward global vaccination through pledging doses at no- to low-profit rates.

In the face of a growing clamor for greater worldwide access to COVID-19 vaccines, biopharma companies are promising to expand distribution of free and low-cost preventives to curb the pandemic globally.

EMA has provided further advice to healthcare professionals on blood clots and low blood platelets occurring after vaccination with Vaxzevria (formerly the COVID-19 Vaccine AstraZeneca).

Moderna and Aldevron have expanded their existing collaboration to support Moderna’s COVID-19 vaccine program as well as additional clinical programs in Moderna’s pipeline.

Codagenix and Univercells have partnered on a research collaboration to pursue an undisclosed, high-priority human vaccine target.

In the study, which enrolled 3700 US participants ages 12 to less than 18 years, no cases of COVID-19 were found in participants who had received two doses of the Moderna COVID-19 vaccine.

Samsung Biologics plans to support the production of hundreds of millions of doses of Moderna’s vaccine to supply to markets outside of the United States beginning in the third quarter of 2021.

The agency is authorizing extending the time undiluted, thawed vaccine vials can be stored in the refrigerator to one month.