Regulation - Marketing Authorisation

Sanofi, Regeneron bag EC approval for skin cancer drug Libtayo

Sanofi and Regeneron Pharmaceuticals have been given conditional approval by the European Commission (EC) for their fully-human monoclonal antibody Libtayo (cemiplimab) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in adults.

EC approves ZYNTEGLO gene therapy for transfusion-dependent β-thalassemia

bluebird bio has secured conditional marketing authorisation from the European Commission (EC) for its one-time gene therapy ZYNTEGLO (autologous CD34+ cells encoding βA-T87Q-globin gene) for the treatment of transfusion-dependent β-thalassemia (TDT).

Santhera seeks EMA approval for idebenone in Duchenne muscular dystrophy

Santhera Pharmaceuticals has filed a marketing authorization application (MAA) to the European Medicines Agency (EMA) for the approval of Puldysa (idebenone) for the treatment of respiratory dysfunction in patients with Duchenne muscular dystrophy (DMD).

Pfizer receives positive CHMP opinion for TALZENNA for patients with inherited BRCA-mutated locally advanced or metastatic breast cancer

Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending TALZENNA (talazoparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor, be granted marketing authorization in the European Union (EU).

Lynparza secures European approval for type of advanced breast cancer

The European Commission has expanded the approval of AstraZeneca and MSD’s Lynparza (olaparib) to cover the treatment of a form of advanced breast cancer.

European Commission approves Roche’s Hemlibra for people with severe haemophilia A without factor VIII inhibitors

Roche announced that the European Commission has approved Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes in people with severe haemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors.

Roche gets EC nod for Tecentriq and Avastin combo for first-line lung cancer

Roche has secured marketing authorization from the European Commission (EC) for its Tecentriq (atezolizumab) in combination with Avastin (bevacizumab) and chemotherapy for initial treatment of people with a specific type of metastatic lung cancer.

Pfizer’s lung cancer drug Lorviqua recommended for marketing authorization in EU

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Pfizer’s Lorviqua (lorlatinib) to treat adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC).

CHMP recommends Keytruda-chemo combo in squamous NSCLC

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended Merck’s Keytruda plus chemotherapy to treat metastatic squamous non-small cell lung cancer (NSCLC).