Regulation

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).

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).