Regulation

FDA approves subcutaneous formulation of Actemra to treat systemic juvenile idiopathic arthritis

Genentech, a member of the Roche Group, that the US Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older.

Ironwood secures FDA fast track designation for heart drug praliciguat

Ironwood Pharmaceuticals has secured fast track designation from the US Food and Drug Administration (FDA) for praliciguat (IW-1973) for the treatment of patients with heart failure with preserved ejection fraction (HFpEF).

Shire’s Veyvondi secures approval in Europe for bleeding disorder

The European Commission (EC) has granted Marketing Authorization for VEYVONDI [vonicog alfa, recombinant von Willebrand factor] (rVWF), to treat bleeding events and treatment/prevention of surgical bleeding in adults (age 18 and older) with von Willebrand disease (VWD) when desmopressin (DDAVP) treatment alone is ineffective or not indicated.

Scottish Medicines Consortium accepts Sanofi’s Dupixent to treat moderate to severe atopic dermatitis

The Scottish Medicines Consortium (SMC) has accepted Dupixent (dupilumab) for restricted use within its existing marketing authorisation.

Merck’s Keytruda combo therapy approved in Europe to treat metastatic NSCLC

Merck has secured approval from the European Commission for its anti-PD-1 therapy Keytruda (pembrolizumab) in combination with pemetrexed (ALIMTA) and platinum chemotherapy to treat a type of metastatic nonsquamous non-small cell lung cancer (NSCLC).

Teva secures FDA approval for new dosage strength of Cassipa to treat opioid dependence

Teva Pharmaceuticals USA has secured approval from the US Food and Drug Administration (FDA) for its Cassipa (buprenorphine and naloxone) sublingual film (applied under the tongue) as the maintenance treatment for opioid dependence.

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).