Marketing Authorisation

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).

AstraZeneca’s Forxiga recommended for marketing authorization in EU

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended AstraZeneca’s Forxiga (dapagliflozin) to treat adults with type-1 diabetes (T1D).

Vertex secures Health Canada approval for expanded use of KALYDECO

Vertex Pharmaceuticals announced that Health Canada has granted Market Authorization for KALYDECO (ivacaftor) to include use in children with cystic fibrosis (CF) ages 12 to <24 months who have one of the following mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene: G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N or S549R.

Janssen gets EC nod for prostate cancer drug Erleada

The Janssen Pharmaceutical Companies of Johnson & Johnson has secured marketing approval from the European Commission (EC) for Erleada (apalutamide) to treat non-metastatic castration-resistant prostate cancer (nmCRPC).

Zydus Cadila secures USFDA nod to market acne drug

Zydus Cadila, an Indian pharmaceutical company, has obtained final approval from the US Food and Drug Administration (FDA) to market Clindamycin Phosphate and Benzoyl Peroxide Gel.

European CHMP adopts positive opinion for Pfizer’s oncology biosimilar Zirabev

Pfizer announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended marketing authorization for Zirabev (bevacizumab), a potential biosimilar to Avastin (bevacizumab).