Regulation

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).

Merck’s 15-valent pneumococcal conjugate vaccine gets FDA breakthrough therapy designation

Merck has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for its V114 investigational 15-valent pneumococcal conjugate vaccine.

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.

FDA approves Imbruvica combo for treatment-naive CLL patients

Johnson & Johnson (J&J) and AbbVie have secured approval from the US Food and Drug Administration (FDA) for Imbruvica plus obinutuzumab as non-chemotherapy combination regimen for treatment- naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

FDA accepts X-Rx’s IND application for X-165 to treat IPF

The US Food and Drug Administration (FDA) has accepted X-Rx's investigational new drug application (IND) for X-165 being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF).

EC approves Clovis’ Rubraca to treat women with relapsed ovarian cancer

Clovis Oncology has secured approval from the European Commission (EC) for its Rubraca (rucaparib) as maintenance treatment for women with relapsed ovarian cancer.

EC approves Blincyto in patients with Philadelphia chromosome negative minimal residual disease-positive B-cell precursor ALL

Amgen announced that the European Commission (EC) has approved an expanded indication for BLINCYTO (blinatumomab) monotherapy to include adult patients with Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent.

Rocket Pharmaceuticals announces clearance of IND for RP-A501 gene therapy for Danon disease

Rocket Pharmaceuticals, Inc. (Nasdaq: RCKT) (“Rocket”), a leading U.S.-based multi-platform gene therapy company, today announces the clearance of the Company’s Investigational New Drug (IND) application by the U.S. Food and Drug Administration (FDA) for RP-A501.

EC approves Vertex’s CF treatment Orkambi for children aged two to five years

Vertex Pharmaceuticals (Europe) has secured approval from the European Commission (EC) for Orkambi (lumacaftor/ivacaftor) to treat of children with cystic fibrosis (CF) aged two to five years old who have two copies of the F508del mutation.