Regulation

FDA refuses to approve GSK’s respiratory drug mepolizumab for COPD

The US Food and Drug Administration (FDA) has refused to approve the use of GlaxoSmithKline’s mepolizumab for treating patients with chronic obstructive pulmonary disease (COPD) on grounds of needing more clinical data.

Merck’s Keytruda gets priority review from FDA for Merkel cell carcinoma indication

Merck’s anti-PD-1 therapy Keytruda has been granted priority review designation by the US Food and Drug Administration (FDA) for the treatment of Merkel cell carcinoma.

Sanofi gets EC approval for blood-clotting disorder drug Cablivi

Sanofi has secured marketing approval from the European Commission for its Cablivi (caplacizumab) to treat adults with acquired thrombotic thrombocytopenic purpura (aTTP).

FDA approves Bayer’s Jivi for Hemophilia A patients aged 12 and older

The US Food and Drug Administration (FDA) has approved Jivi (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older.

Sunovion fails to get FDA approval for dasotraline in ADHD

Sunovion Pharmaceuticals has failed to get approval from the US Food and Drug Administration (FDA) for dasotraline to treat attention-deficit hyperactivity disorder (ADHD).

Merck secures FDA approval for two HIV drugs

Merck has secured approval from the US Food and Drug Administration (FDA) for its two new HIV-1 treatments, Delstrigo and Pifeltro.

EC grants orphan drug status to Trovagene’s Onvansertib for AML treatment

Trovagene has announced that the European Commission (EC) has endorsed the positive opinion of the Committee for Orphan Medicinal Products (COMP) and granted orphan drug designation (ODD) for Onvansertib to treat patients with acute myeloid leukemia (AML).

Purdue to pay Assertio $62m to settle patent infringement lawsuit

Assertio Therapeutics has reached a settlement with Purdue Pharma over a patent infringement lawsuit it filed against the latter related to its commercialization of Oxycontin (oxycodone hydrochloride-controlled release).

Novartis’ Kymriah CAR-T cell therapy secures European approval

Novartis has secured the European Commission (EC) approval for its CAR-T cell therapy Kymriah (tisagenlecleucel) for the treatment of B-cell acute lymphoblastic leukemia.