Formulation and Drug Delivery

GMPs Guide COVID-19 Vaccine Manufacturing

November 03, 2020

Recent industry guidance aims to anchor rapid COVID-19 vaccine development in good manufacturing practice protocols.

COVID-19 Vaccine Distribution Raises Multiple Challenges

November 02, 2020

Experts fear confusion over allocation processes, cold-chain requirements, and IT systems needed to bring a COVID-19 vaccine to market.

Predicting Generic Drug Marketing Applications

October 30, 2020

The Center for Drug Evaluation and Research is studying factors that influence the development of generic versions of brand-name drugs.

EMA Implements Transparency Measures for COVID-19 Medicines

October 30, 2020

The agency published clinical data on remdesivir and information about COVID-19 treatments that have received scientific advice or informal guidance from EMA’s pandemic Task Force.

Takeda, Moderna, and the Government of Japan to Collaborate to Distribute 50 Million COVID-19 Vaccine Doses

October 29, 2020

Through the agreement, Takeda will handle securing the regulatory approvals before distributing the doses, while Moderna will supply the finished product.

Sanofi and GSK Agree to Support COVAX with 200 Million COVID-19 Vaccines Doses

October 28, 2020

The companies have signed a Statement of Intent with Gavi to make 200 million doses of their adjuvanted recombinant protein-based COVID-19 vaccine available for distribution.

Novavax COVID-19 Vaccine Trial Expands Enrollment

October 27, 2020

The Phase III clinical trial of NVX-CoV2373 is expected to be fully enrolled in the UK and will begin in the US and Mexico by the end of November 2020.

Evonik Launches New Ready-To-Use Powder Premix Blend

October 27, 2020

The new premix can be used with tablets and a range of other solid oral dosage forms.

FDA Vaccine Committee Meets About COVID-19 Vaccines

October 22, 2020

The agency’s Vaccines and Related Biological Products Advisory Committee met to discuss COVID-19 vaccine approvals, post-marketing safety studies, and ongoing safety monitoring of vaccines.

Catalent Introduces New Softgel Technology

October 20, 2020

OptiGel DR softgel capsules are formed by the combination of pectin, a naturally derived polysaccharide, and gelatin, which eliminates the need for a separate capsule coating step.