USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency

Pfizer announces positive topline results from Phase 3 study of Hemophilia B gene therapy candidate

LG Chem inks deal with Innovent Biologics for gout treatment candidate

LG Chem will receive totaling up to $95.5 million for the China rights

Valneva and Pfizer report antibody persistence data for lyme disease vaccine candidate

Antibody levels remained above baseline six months after completion of a three-dose (Month 0-2-6) or a two-dose (Month 0-6) vaccination schedule

GSK’s respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA

This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan

Merck and the Bill & Melinda Gates Medical Research Institute announce licensing agreement for tuberculosis antibiotic candidates

The TBDA is a collaboration established among biopharmaceutical companies, research organizations and universities to accelerate the discovery and development of novel therapeutic candidates against TB.

Lupin and DKSH sign licensing and supply agreement to market five biosimilar candidates in the Philippines

Lupin’s subsidiary in Philippines, Multicare Pharmaceuticals, will file for marketing approval and be responsible for distribution and commercialization of the biosimilars once approved.

CureVac, GSK start Phase 1 clinical study of omicron-targeting COVID-19 vaccine candidate

Phase 1 dose-escalation study to be conducted at clinical sites in the U.S., the UK, Australia, and the Philippines

Pfizer and BioNTech advance COVID-19 vaccine strategy with study start of next-generation vaccine candidate

This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant.

Pfizer and BioNTech announce Omicron-adapted COVID-19 vaccine candidates demonstrate high immune response against omicron

Both vaccine candidates demonstrated a favorable safety and tolerability profile similar to the Pfizer-BioNTech COVID-19 Vaccine