Regulation

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.

Lilly’s second immune-oncology candidate using Zymeworks’ Azymetric platform to start clinical trials

Zymeworks, a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported the achievement of a new development milestone in its collaboration with Eli Lilly and Company (“Lilly”).

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).

Silence’s SLN124 gets orphan designation in Europe for β-Thalassemia

Silence Therapeutics’ lead candidate SLN124 has secured orphan drug designation in the European Union for the treatment of β-Thalassemia.

Exelixis announces US FDA approval of CABOMETYX tablets for previously treated HCC

Exelixis announced that the U.S. Food and Drug Administration (FDA) approved CABOMETYX (cabozantinib) tablets for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib.

Pfizer’s tafamidis secures FDA priority review for ATTR-CM

Pfizer’s tafamidis meglumine form (20mg capsule) has secured priority review from the US Food and Drug Administration (FDA) for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).