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Regulatory Affairs

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).
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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.
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FDA accepts sBLA, grants priority review for Genentech’s cervical cancer therapy Avastin plus
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application (sBLA) and granted priority review for Avastin (bevacizumab) plus chemotherapy to treat women with persistent, recurrent or metastatic cervical cancer.
Regulatory Affairs > News
Sunovion gets Canadian approval for Aptiom to treat partial-onset seizures
By PBR Staff Writer
Sunovion Pharmaceuticals Canada has received approval from Health Canada for Aptiom (eslicarbazepine acetate) for use as a once-daily adjunctive drug (AED) to treat partial-onset seizures in patients with epilepsy who are not satisfactorily controlled with conventional therapy.
Regulatory Affairs > News
European Commission grants orphan drug status to Zafgen for beloranib to treat PWS
By PBR Staff Writer
US-based biopharmaceutical firm Zafgen has received orphan drug designation from the European Commission (EC) for beloranib to treat patients with Prader-Willi syndrome (PWS).
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Bristol-Myers to submit BLA in US for melanoma drug Opdivo
By PBR Staff Writer
US-based Bristol-Myers Squibb (BMS) is planning a third quarter submission of a Biologics Licensing Application (BLA) to the US Food and Drug Administration (FDA) for Opdivo (nivolumab) for previously treated advanced melanoma.
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Astellas files NDA in US for Isavuconazole to treat zygomycosis
By PBR Staff Writer
Astellas has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for the approval of isavuconazole to treat invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), life-threatening fungal infections predominantly occurring in immunocompromised patients.
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Sunesis gets EMA acceptance of Pediatric Investigation Plan for Qinprezo to treat AML
The European Medicines Agency's (EMA) Pediatric Committee has issued a positive opinion on US-based Sunesis Pharmaceuticals's Pediatric Investigation Plan (PIP) for Qinprezo (vosaroxin), its lead drug candidate.
Regulatory Affairs > News
Purdue gets FDA priority review designation for hydrocodone bitartrate tablets
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted priority review designation for US-based Purdue Pharma's hydrocodone bitartrate extended-release tablets for treatment of chronic pain.
Regulatory Affairs > News
Bristol-Myers Squibb's combination drug for Hepatitis C treatment gets Japanese approval
By PBR Staff Writer
Bristol-Myers Squibb (BMS) has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Daklinza (daclatasvir) and Sunvepra (asunaprevir), as a new treatment that can lead to cure for many patients with genotype 1 chronic hepatitis C virus (HCV) infection in Japan.
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