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Regulatory Affairs

Vertex receives European approval for KALYDECO in eight non-G551D gating mutations Vertex Pharmaceuticals has announced that the European Commission has approved KALYDECO (ivacaftor) for people with cystic fibrosis (CF) ages 6 and older who have one of eight non-G551D gating mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene
Regulatory Affairs > News
Alimera's Iluvein gets marketing authorization in Denmark for DME treatment By PBR Staff Writer
US-based biopharmaceutical firm Alimera Sciences has received authorization from Danish authorities to sell its drug Iluvien, indicated for the treatment of vision impairment associated with chronic diabetic macular edema (DME), in the country.
Regulatory Affairs > News European Commission approves BMS- Pfizer's Eliquis to treat DVT, PE By PBR Staff Writer
The European Commission (EC) has approved Bristol-Myers Squibb (BMS) and Pfizer's Eliquis, an oral selective Factor Xa inhibitor, for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as prevention of recurrent DVT and PE in adults.
Regulatory Affairs > News
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Roche gets European approval for leukemia treatment Gazyvaro
By PBR Staff Writer
Swiss health-care firm Roche has received approval from the European Commission for Gazyvaro (obinutuzumab) in combination with chlorambucil chemotherapy to treat people with previously untreated chronic lymphocytic leukemia (CLL) who have comorbidities making them unsuitable for an intensive therapy (full-dose fludarabine based therapy).
Regulatory Affairs > News
Alimera' ILUVIEN gets marketing authorization in Norway to treat chronic DME
By PBR Staff Writer
US-based biopharmaceutical firm Alimera Sciences has received marketing authorization from the Norwegian Medicines Evaluation Board for ILUVIEN to treat vision impairment associated with chronic diabetic macular edema (DME) considered insufficiently responsive to available therapies.
Regulatory Affairs > News
CHMP recommends Allergan's OZURDEX to treat diabetic macular edema
By PBR Staff Writer
Allergan has received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending extension of the marketing authorization for OZURDEX to treat adult patients with vision loss due to diabetic macular edema (DME).
Regulatory Affairs > News
European CHMP adopts positive opinion for Gilead’s Zydelig to treat chronic lymphocytic leukemia and follicular lymphoma
Gilead Sciences has announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion on the company’s Marketing Authorization Application (MAA) for Zydelig (idelalisib 150 mg film-coated tablets), a first-in-class treatment for patients with chronic lymphocytic leukemia (CLL) and follicular lymphoma (FL), the most common subtype of indolent non-Hodgkin lymphoma (iNHL).
Regulatory Affairs > News
EMA committee recommends full approval of Imbruvica to treat two blood cancers
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending the granting of full marketing approval for Pharmacyclics' Imbruvica (ibrutinib) in the European Union (EU).
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FDA grants Genentech’s Avastin priority review for recurrent platinum-resistant ovarian cancer
Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.
Regulatory Affairs > News
Regulus gets FDA orphan drug status for RG-012 to treat Alport Syndrome
By PBR Staff Writer
US-based biopharmaceutical firm Regulus Therapeutics has received orphan drug designation from the US Food and Drug Administration (FDA) for RG-012, a single stranded, chemically modified oligonucleotide.
Regulatory Affairs > News
CTI BioPharma expands access to PIXUVRI with approval in Israel
BioPharma has received approval from the Israeli Ministry of Health (MOH) for PIXUVRI (pixantrone).
Regulatory Affairs > News
Boehringer gets FDA breakthrough status for IPF treatment for nintedanib
By PBR Staff Writer
Germany-based Boehringer Ingelheim has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its investigational therapy nintedanib to treat idiopathic pulmonary fibrosis (IPF), a devastating and fatal lung disease.
Regulatory Affairs > News
Pendopharm gets Health Canada approval for hepatitis C drug Ibavyr
By PBR Staff Writer
Pendopharm, a division of Pharmascience, has secured Health Canada approval and market availability of IBAVYR (ribavirin tablets), the first stand-alone oral ribavirin for the treatment of chronic hepatitis C virus (HCV) infections in Canada.
Regulatory Affairs > News
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