FDA grants breakthrough status to Eisai and Biogen’s Alzheimer’s drug
The breakthrough designation is based on positive data from the Phase IIb Study 201 trial in Alzheimer’s patients.
Regulation
FDA approves Boehringer’s oral blood thinner Pradaxa for children
Pradaxa, initially authorised in 2010, is the first oral blood thinner approved by the FDA...
EU gets partial win in AstraZeneca Covid-19 vaccine supply case
If AstraZeneca fails to supply in compliance with the court ruling, the company will have...
Australia recommends AstraZeneca Covid-19 vaccine for people over 60
The AstraZeneca vaccine is now preferred in Australia for this age group due to an...
Novartis prostate cancer drug gets FDA breakthrough designation
The FDA breakthrough designation is based on positive results from the Phase III VISION study...
Aducanumab: Promising Alzheimer’s drug or dangerous precedent?
The FDA has overruled the recommendations of its advisory panel, who were almost unanimously against approving the controversial drug.
FDA approves Mallinckrodt’s StrataGraft for thermal burns treatment
The approval of Mallinckrodt’s StrataGraft is backed by positive data from a Phase III trial in patients with deep partial-thickness burns.
Humanigen starts rolling submission for Covid-19 drug in the UK
Humanigen, which previously sought EUA from the US FDA for lenzilumab to treat Covid-19, is seeking marketing approval by the MHRA for the drug.
FDA authorises J&J Covid-19 vaccine substance made at Emergent’s plant
The agency extends the expiration date of the vaccine to 4.5 months when refrigerated at temperatures of 2-8°C.
Ocugen to seek full approval for Bharat Biotech’s Covaxin in the US
Ocugen has exclusive rights to commercialise Covaxin in Canada and is in discussions to obtain potential regulatory authorisation.
Vertex’s Trikafta gets FDA approval to treat cystic fibrosis in children
Trikafta received FDA approval for cystic fibrosis patients aged six to 11, having previously received the FDA nod for treating patients aged 12 and above.
