Regulation

Novartis’ Mayzent gets EC nod for secondary progressive multiple sclerosis

Novartis has secured approval for Mayzent (siponimod) in the European Union (EU) for the treatment of secondary progressive multiple sclerosis (SPMS) in adults.

Jazz Pharmaceuticals receives EU marketing authorisation for Sunosi for excessive daytime sleepiness in adults with narcolepsy or OSA

Jazz Pharmaceuticals announced that the European Commission approved Sunosi (solriamfetol) to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy (with or without cataplexy) or obstructive sleep apnea (OSA) whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure (CPAP).

AstraZeneca gets FDA orphan drug status for Imfinz plus tremelimumab to treat hepatocellular carcinoma

AstraZeneca has secured orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for Imfinzi (durvalumab) and tremelimumab to treat liver cancer called hepatocellular carcinoma (HCC).

Janssen seeks EMA nod for Imbruvica, rituximab combo in previously untreated CLL

The Janssen Pharmaceutical Companies of Johnson & Johnson has applied to the European Medicines Agency (EMA) seeking the approval of Imbruvica (ibrutinib) in combination with rituximab as first-line treatment in previously untreated chronic lymphocytic leukaemia (CLL).

FDA accepts for priority review Bristol-Myers Squibb’s application for Opdivo plus Yervoy in first-line NSCLC

Bristol-Myers Squibb announced the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations.

ViiV Healthcare secures Japanese approval for Dovato to treat HIV-1 infection

Specialist HIV company ViiV Healthcare has secured Japanese approval for Dovato (dolutegravir 50mg/lamivudine 300mg) two-drug regimen to treat of HIV-1 infection.

ViiV Healthcare seeks EMA approval for HIV-1 drug candidate fostemsavir

ViiV Healthcare has completed a regulatory filing in Europe seeking the approval for fostemsavir for the treatment of HIV-1 infection in adult patients having limited treatment options.

Alnylam initiates rolling submission of NDA for Lumasiran in primary Hyperoxaluria Type 1

Alnylam Pharmaceuticals has initiated a rolling submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lumasiran, an investigational RNAi therapeutic targeting glycolate oxidase for the treatment of primary hyperoxaluria type 1 (PH1).

Merck gets FDA nod for Keytruda to treat BCG-unresponsive, high-risk NMIBC

Merck has secured approval from the US Food and Drug Administration (FDA) for its Keytruda to treat patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC).