Drug Development

Articles

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

EMA Recommends Change in Storage Conditions for Pfizer/BioNTech Vaccine

Sanofi and GlaxoSmithKline reported that their adjuvanted recombinant COVID-19 vaccine candidate demonstrated strong immune responses across all adult age groups in a Phase II trial.

Sanofi and GSK Report Strong Immune Response with COVID-19 Vaccine Candidate

The US Supreme Court has denied a petition by Sandoz, a Novartis company, to review a July 2020 ruling concerning its biosimilar Erelzi (etanercept-szzs), blocking the company from launching the product.

US Supreme Court Denies Sandoz Biosimilar Etanercept Petition

Jennifer Markarian is a contributing editor for 

Supply-chain visibility systems are proving their worth in the distribution of COVID-19 vaccines and may see broader use in the future.

Tracking Technologies Guard Vaccine Cold Chain

Adolescents are now eligible for the Pfizer-BioNTech COVID-29 vaccine under expanded EUA.

FDA OKs Pfizer-BioNTech Vaccine for Adolescents

Pfizer and BioNTech have initiated a rolling submission of a biologics license application to FDA for the approval of their COVID-19 vaccine in individuals 16 years of age and older.

Pfizer and BioNTech Initiate Rolling Submission of Biologics License Application for Their COVID-19 Vaccine

Eli Lilly and Company has partnered with leading diabetes tech firms to offer app compatibility with insulin smart pens to streamline diabetes management with automated data collection.

Lilly Forms Pact with Diabetes Tech Companies to Integrate Connected Insulin Pen Solutions

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Sandoz Begins Late-Stage Clinical Development for Biosimilar Aflibercept

The European Medicines Agency has announced the commencement of an evaluation for the extension of use of Comirnaty, Pfizer/BioNTech’s COVID-19 vaccine, to include young people aged 12 to 15 years.

Accelerated Assessment of Comirnaty in Young People Commences

The European Medicines Agency’s Committee for Medicinal Products for Human Use has started a rolling review of Vero Cell, an inactivated COVID-19 vaccine developed by Sinovac Life Sciences. 

Formulation and Drug Delivery