Respiratory
Record number of respiratory syncytial virus (RSV) designations awarded in 2022
In 2022, global regulatory authorities awarded a record ten review designations for respiratory syncytial virus (RSV)-indicated drugs. This surge acted…
Advent receives US NIH grant for bronchopulmonary dysplasia therapy
Advent Therapeutics has received a small business innovation research grant worth $3m from the US National Institutes of Health (NIH)…
MHRA approves GSK’s RSV vaccine for older adults in the UK
Older adults in the UK will soon be able to receive protection against respiratory syncytial virus (RSV) after the Medicines…
Eloxx repackages ELX-02 data in cystic fibrosis as it eyes pivotal trial
Eloxx has revealed its lead candidate ELX-02 improved predicted forced expiratory volume (ppFEV1) in patients with Class 1 cystic fibrosis…
EC grants marketing authorisation for GSK’s RSV vaccine Arexvy
The European Commission (EC) has granted marketing authorisation for GSK’s respiratory syncytial virus (RSV) vaccine, Arexvy, for adults aged 60…
Janssen submits NDA to FDA for PAH combination therapy
The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a new drug application (NDA) for its investigational single-tablet combination…
Betta to commercialise C4 Therapeutics’ CFT8919 in greater China
C4 Therapeutics has entered an exclusive licensing agreement with Betta Pharmaceuticals to develop and commercialise CFT8919 across the greater China…
Clover collaborates with Kyuan Trade to launch AdimFlu-S (QIS) in China
Clover Biopharmaceuticals has established a commercial collaboration with Keyuan Xinhai (Beijing) Medical Products Trading (Kyuan Trade) for the launch of…
Inovio’s INO-3107 receives orphan drug status from EC
Inovio has received orphan drug designation for INO-3107 from the European Commission (EC) to treat recurrent respiratory papillomatosis (RRP). The…
Croda Pharma and BSI partner for vaccine adjuvant QS-21 production
Croda Pharma has entered a strategic collaboration deal with Botanical Solution Inc (BSI) to expedite the production of sustainable pharmaceutical-grade…