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Regulatory Affairs

EMA committee recommends AstraZeneca's ovarian cancer drug Lynparza By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending AstraZeneca's marketing authorization of ovarian cancer drug Lynparza (olaparib) as monotherapy.
Regulatory Affairs > News
NICE recommends Bayer's rivaroxaban as option for secondary prevention in ACS By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has issued its Appraisal Consultation Document (ACD) recommending Bayer HealthCare's Xarelto (rivaroxaban) 2.5mg twice daily as an option for secondary prevention in acute coronary syndrome (ACS).
Regulatory Affairs > News EMA grants orphan status for GW Pharmaceuticals' Epidiolex to treat Dravet syndrome By PBR Staff Writer
The European Medicines Agency (EMA) has granted orphan designation to GW Pharmaceuticals' investigational product Epidiolex (cannabidiol or CBD) to treat Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.
Regulatory Affairs > News
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NICE recommends GSK's skin cancer drug Tafinlar
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has issued final guidance recommending GlaxoSmithKline's (GSK) Tafinlar (dabrafenib) to treat certain NHS patients with melanoma, a type of skin cancer.
Regulatory Affairs > News
FDA approves Auxilium's Xiaflex to treat Dupuytren's Contracture
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved a supplemental Biologics Application (sBLA) for Auxilium Pharmaceuticals' Xiaflex (collagenase clostridium histolyticum or CCH) to treat up to two Dupuytren's contracture (DC) joints in the same hand during a single treatment visit.
Regulatory Affairs > News
Novartis' plaque psoriasis drug candidate AIN457 gets FDA committee recommendation
By PBR Staff Writer
The US Food and Drug Administration's (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) has approved Novartis' AIN457 (secukinumab), a selective interleukin-17A (IL-17A) inhibitor, to treat moderate-to-severe plaque psoriasis in adult patients.
Regulatory Affairs > News
Pharmacyclics' Imbruvica gets European approval to treat two blood cancers
By PBR Staff Writer
The European Commission (EC) has granted marketing approval for Pharmacyclics' Imbruvica (ibrutinib), a first-in-class, oral, once-daily, non-chemotherapy treatment for patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukemia (CLL).
Regulatory Affairs > News
Health Canada issues notice of compliance for Gilead hepatitis C drug Harvoni
By PBR Staff Writer
Health Canada has issued a Notice of Compliance for Gilead Sciences' Harvoni (ledipasvir 90 mg/sofosbuvir 400mg), the first once-daily single tablet regimen to treat chronic hepatitis C genotype 1 infection in adults.
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FDA approves Boehringer's Ofev to treat idiopathic pulmonary fibrosis
By PBR Staff Writer
The US Food and Drug Administration has approved Boehringer Ingelheim Pharmaceuticals' Ofev (nintedanib) capsules to treat idiopathic pulmonary fibrosis (IPF).
Regulatory Affairs > News
Genentech gets FDA approval for Esbriet to treat idiopathic pulmonary fibrosis
By PBR Staff Writer
Genentech, Roche's subsidiary, has received approval from US Food and Drug Administration (FDA) for Esbriet (pirfenidone) to treat patients with idiopathic pulmonary fibrosis (IPF).
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FDA grants priority review designation for Eisai's Lenvatinib to treat advanced thyroid cancer
By PBR Staff Writer
The US Food and Drug Administration (FDA) has accepted to review Eisai's new drug application (NDA) and has granted Priority Review status for its in-house developed agent lenvatinib mesylate (lenvatinib) to treat progressive radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC).
Regulatory Affairs > News
ViiV Healthcare secures Canadian approval for Triumeq to treat HIV-1
By PBR Staff Writer
ViiV Healthcare, a joint venture of GlaxoSmithKline (GSK), Pfizer and Shionogi, has secured approval in Canada, for its Triumeq (dolutegravir 50mg, abacavir 600mg, and lamivudine 300mg) to treat patients with Human Immunodeficiency Virus (HIV-1) infection.
Regulatory Affairs > News
Orexo submits application to FDA for expanded label of ZUBSOLV
Orexo announces that it has submitted an application to the US Food and Drug Administration (FDA) for an expanded label of ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) to include initiation of treatment for opioid dependence.
Regulatory Affairs > News
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