Approvals

USFDA authorises baricitinib for emergency use as monotherapy for Covid-19 patients

The US Food and Drug Administration (FDA) has extended the Emergency Use Authorization (EUA) for Eli Lilly and Company and Incyte's baricitinib to treat Covid-19 patients with or without remdesivir.

EMA’s CHMP recommends EU approval for Moderna’s Covid-19 vaccine for adolescents

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorisation for Moderna’s Covid-19 vaccine, Spikevax, for adolescents aged 12 to 17 years.

FDA approves Merck, Eisai’s Keytruda and Lenvima combination for endometrial cancer

Merck and Eisai have secured approval from the US Food and Drug Administration (FDA) for Keytruda (pembrolizumab) plus Lenvima (lenvatinib) combination to treat patients with certain types of advanced endometrial carcinoma.

AstraZeneca completes acquisition of biopharmaceutical firm Alexion

AstraZeneca has completed the acquisition of biopharmaceutical company Alexion Pharmaceuticals in a deal valued at $39bn.

Japan approves Roche’s Ronapreve for Covid-19 treatment

Roche has received Japan’s Ministry of Health, Labour and Welfare (MHLW) approval for its Ronapreve to treat mild to moderate Covid-19 patients.

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.

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).