Infectious Disease

UK’s MHRA approves Beyfortus (nirsevimab) to prevent RSV in infants

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has given approval to Beyfortus (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants during their first RSV season.

Bavarian Nordic and PAHO sign agreement for monkeypox vaccines

Bavarian Nordic has signed a supply agreement with the Pan American Health Organization (PAHO) for its monkeypox vaccine.

Bharat Biotech’s COVAXIN proven to be safe in subjects in controlled clinical trials

Bharat Biotech International Limited (BBIL) has announced that its whole-virion inactivated COVID-19 vaccine, BBV152 (COVAXIN), has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials.

Intravac signs licensing deal with Zhifei Lvzhu for whooping cough vaccine

Intravacc has signed an exclusive licensing agreement with Beijing Zhifei Lvzhu Biopharmaceutical (Zhifei Lvzhu) in China for Avacc 3, an OMV-based whooping cough vaccine.

BenevolentAI, DNDi begin joint AI research project on dengue

BenevolentAI and Drugs for Neglected Disease initiative (DNDi) have commenced a joint AI research project to address dengue.

Merck signs agreement with Thermo Fisher Scientific to manufacture molnupiravir

Merck (MSD outside Canada and the US) has signed an agreement with Thermo Fisher Scientific to manufacture molnupiravir, an investigational oral antiviral medicine to treat Covid-19.

EMA begins rolling review of Valneva’s Covid-19 vaccine candidate VLA2001

The European Medicines Agency (EMA) has begun a rolling review of Valneva’s VLA2001, a whole-virus inactivated, adjuvanted Covid-19 vaccine candidate.

FDA gives expanded EUA for Pfizer-BioNTech Covid-19 vaccine booster dose

The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorization (EUA) of a booster dose of the Pfizer-BioNTech Covid-19 vaccine.

Enzolytics, Samsung Biologics partner to develop therapies for HIV, Covid-19

Samsung Biologics and Enzolytics have entered a strategic contract development and manufacturing organization (CDMO) collaboration agreement to develop and produce monoclonal antibody treatments for human immunodeficiency virus (HIV) and Covid-19.