Health Canada approves J&J Covid-19 vaccine for use in adults
Health Canada granted the approval based on scientific data from a Phase III trial involving 43,783 subjects.
Regulation
FDA approves Takeda’s Livtencity for post-transplant cytomegalovirus
Livtencity, which works by hindering human cytomegalovirus enzyme pUL97 activity, will be commercially available soon.
Zydus Cadila seeks DCGI approval for oral CKD-associated anaemia treatment
In two Phase III trials, Desidustat increased mean haemoglobin (Hb) levels, which was maintained for 24 weeks.
The dark consequences of drug supply shortages
Drug shortages caused by supply chain issues or political decisions can open the door to...
EMA CHMP issues advice on usage of Merck-Ridgeback’s Covid-19 medicine
The Lagevrio capsule is intended to be used immediately on detecting Covid-19 and within five...
FDA grants expanded EUA to Pfizer-BioNTech’s Covid-19 booster shot
The booster shot is intended to be administered a minimum of six months after inoculation with the initial two-dose regimen.
Paxlovid: what we know about Pfizer’s Covid-19 pill
Pfizer is seeking emergency use authorisation from the FDA for its novel Covid-19 antiviral pill Paxlovid.
Philippine FDA grants EUA to Novavax’s Covid-19 vaccine
Serum Institute of India will manufacture and commercialise the vaccine as Covovax in the Philippines.
FDA grants priority review to Boehringer-Lilly’s Jardiance for heart failure
The FDA accepted an sNDA, which is based on data from the Phase III trial of the therapy.
AI in healthcare: key highlights in 2021
As AI and machine learning continues to evolve, we look at how it has impacted healthcare in 2021.
Oklahoma supreme court overturns ruling against J&J in $465m opioid lawsuit
The state filed a lawsuit against three opioid manufacturers including J&J in 2019 for falsely marketing opioids.
