Regulation

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.

Ocugen plans to seek full approval for Covaxin in US

Ocugen has announced plans to seek full approval from the US Food and Drug Administration (FDA) for Covid-19 vaccine candidate, Covaxin.

Biogen and Eisai get FDA approval for Alzheimer’s drug Aduhelm

Biogen and Eisai have secured accelerated approval from the US Food and Drug Administration (FDA) for Aduhelm (aducanumab-avwa) as the first and only new treatment for Alzheimer’s disease since 2003.