Regulation

US FDA grants priority review to tezepelumab to treat asthma patients

The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) and granted priority review for tezepelumab, which is being developed by AstraZeneca and Amgen, to treat patients with asthma.

AstraZeneca receives European Commission clearance for Alexion acquisition

The European Commission has cleared AstraZeneca’s proposed acquisition of Alexion Pharmaceuticals for $39bn.

Seres, Nestlé to commercialise oral microbiome therapeutic in Canada and US

Seres Therapeutics and Nestlé Health Science have signed an agreement to jointly commercialise SER-109, an investigational oral microbiome therapy, in the US and Canada.

Johnson & Johnson to pay $230m to settle opioid-related claims

Johnson & Johnson (J&J) has reached a $230m agreement to settle the opioid-related claims with the New York State and its participating subdivisions Nassau County and Suffolk County.

FDA allows emergency use of Roche’s Actemra for Covid-19

The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for Roche’s Actemra (tocilizumab) to treat hospitalised Covid-19 patients.

Eisai-Biogen Alzheimer’s drug gets FDA breakthrough designation

Eisai and Biogen have received breakthrough therapy designation from the US Food and Drug Administration (FDA) for their Alzheimer’s disease drug candidate, lecanemab (BAN2401).

Novartis’ prostate cancer drug secures FDA breakthrough designation

Novartis has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for 177Lu-PSMA-617 to treat metastatic castration-resistant prostate cancer (mCRPC).

Mallinckrodt obtains FDA approval for StrataGraft to treat thermal burns

Mallinckrodt has received the US Food and Drug Administration (FDA) approval for StrataGraft to treat thermal burns with intact dermal elements in adults.

EMA’s CHMP approves Moderna’s new Covid-19 vaccine manufacturing site in France

Biotechnology company Moderna has secured approval from the European Medicines Agency’s (EMA) committee for human medicines (CHMP) for a new Covid-19 vaccine manufacturing site in Monts, France.