Infectious Disease

FDA grants approval for Veklury use in Covid-19 patients

The US Food and Drug Administration (FDA) has granted clearance to Gilead Sciences’ supplemental new drug application (sNDA) of Veklury (remdesivir) for use in Covid-19 patients.

MPP signs sublicence agreements for Shionogi’s Ensitrelvir

Medicines Patent Pool (MPP), a UN-supported international public health organisation, has signed seven sublicence agreements for Japanese pharmaceutical firm Shionogi & Co's Ensitrelvir fumaric acid.

Innoviva receives FDA approval for HABP/VABP therapy

Innoviva Specialty Therapeutics has received approval from the US Food and Drug Administration (FDA) for XACDURO to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP).

FDA accepts Valneva’s chikungunya vaccine BLA for priority review

The US Food and Drug Administration (FDA) has finished a filing review of Valneva’s Biologics License Application (BLA) for single-shot chikungunya vaccine candidate VLA1553.

Daiichi Sankyo seeks marketing approval for mRNA Covid-19 vaccine DS-5670 in Japan

Daiichi Sankyo has submitted an application to the regulatory authorities in Japan seeking marketing approval of DS-5670.

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.