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Regulatory Affairs

AstraZeneca's Lynparza gets European approval to treat BRCA-mutated ovarian cancer By PBR Staff Writer
AstraZeneca has received approval from the European Commission (EC) for Lynparza (olaparib) capsules 400mg twice daily as the first therapy to treat adults with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer.
Regulatory Affairs > News
FDA accepts filing Apotex's biosimilar application for pegfilgrastim By PBR Staff Writer
The US Food and Drug Administration has accepted for filing Canadian pharmaceutical firm Apotex's application for pegfilgrastim, a biosimilar version of Amgen's Neulasta.
Regulatory Affairs > News NICE recommends Boehringer's Pradaxa to treat and prevent recurrence of DVT and PE By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has granted approval for Boehringer Ingelheim's dabigatran etexilate (Pradaxa) for use by the National Health Service to treat and prevent the recurrence of deep vein thrombosis (DVT) and pulmonary embolism (PE) in adults.
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ViiV Healthcare seeks Japan's approval for combination drug to treat HIV
By PBR Staff Writer
ViiV Healthcare has submitted a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) seeking approval for the single-pill regimen combining dolutegravir, abacavir and lamivudine, to treat HIV infection.
Regulatory Affairs > News
FDA approves two higher dosage strengths of Orexo's ZUBSOLV
Orexo has received approval from the US Food and Drug Administration (FDA) of two higher dosage strengths of ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) for maintenance treatment of opioid dependence.
Regulatory Affairs > News
Immunovaccine receives FDA fast track status for DPX-Survivac to treat ovarian cancer
Immunovaccine, a clinical stage vaccine and immunotherapy company, announced that DPX-Survivac, the company's lead cancer vaccine candidate, has been granted fast track designation by the US Food and Drug Administration (FDA) as maintenance therapy in subjects with advanced ovarian, fallopian tube, and peritoneal cancer who have no measureable disease following surgery and front-line platinum/taxane chemotherapy to improve their progression-free survival.
Regulatory Affairs > News
GlaxoSmithKline seeks EMA approval for extended indication for ambrisentan to treat PAH
By PBR Staff Writer
GlaxoSmithKline (GSK) has submitted a regulatory application to the European Medicines Agency (EMA) to widen the uses for which its pulmonary arterial hypertension (PAH) treatment ambrisentan (Volibris) can be marketed.
Regulatory Affairs > News
Ignyta receives WHO approval of Nonproprietary name Entrectinib for RXDX-101
Ignyta, a precision oncology biotechnology company, today announced that the World Health Organization (WHO) has approved the international nonproprietary name (INN) “entrectinib” for the company’s lead product candidate, RXDX-101.
Regulatory Affairs > News
AstraZeneca's Moventig gets European marketing authorization for opioid-induced constipation
By PBR Staff Writer
AstraZeneca has received marketing authorization from the European Commission (EC) for Moventig (naloxegol) to treat opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s).
Regulatory Affairs > News
FDA approves Amgen's XGEVA to treat Hypercalcemia
Amgen announced that the US Food and Drug Administration (FDA) has approved a new indication for XGEVA (denosumab) for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy.
Regulatory Affairs > News
Bayer submits marketing authorization application for BAY 81-8973 in Europe
Bayer HealthCare has submitted an application for marketing authorization to the European Medicines Agency (EMA) for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in children and adults.
Regulatory Affairs > News
EMA Committee finds no evidence of serious events in Novartis Fluad vaccine
By PBR Staff Writer
The European Medicines Agency’s (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has concluded that there was no evidence that Novartis-manufactured flu vaccine, Fluad, caused serious events including deaths in Italy.
Regulatory Affairs > News
FDA approves Amgen's BLINCYTO to treat relapsed or refractory B-Cell precursor ALL
By PBR Staff Writer
Amgen has announced that the US Food and Drug Administration (FDA) has granted approval of BLINCYTO™ (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).
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