Log in or Register for enhanced features | Forgotten Password?
White Papers | Suppliers | Events | Report Store | Companies | Dining Club | Medical Devices

Regulatory Affairs
Return to: PBR Home | Regulatory Affairs | News
Search Refinements

Regulatory Affairs News

View news from other Pharmaceutical sectors:
1-15 of 2921 results
UK NICE supports commissioning of Alexion's Soliris to treat aHUS
By PBR Staff Writer
The UK’s National Institute for Health and Care Excellence (NICE) has issued final positive recommendation for national commissioning of Alexion Pharmaceuticals' Soliris (eculizumab) for all patients in England suffering from atypical hemolytic uremic syndrome (aHUS).
Regulatory Affairs > News
Boehringer gets EU marketing approval for lung cancer drug Vargatef
By PBR Staff Writer
The European Commission has granted EU marketing authorisation for Boehringer Ingelheim's Vargatef (nintedanib), a triple angiokinase inhibitor, for the treatment of lung cancer patients.
Regulatory Affairs > News
UK NICE recommends new drug nalmefene to control alcohol consumption
By PBR Staff Writer
The UK's National Institute for Health and Care Excellence (NICE) has approved the use of nalmefene, a once-daily drug that reduces the urge to alcohol consumption.
Regulatory Affairs > News
Alexion's Soliris secures orphan drug designation (ODD) in Japan to treat neuromyelitis optica
By PBR Staff Writer
Alexion Pharmaceuticals has received orphan drug designation (ODD) from Japan’s Ministry of Health, Labour and Welfare (MHLW) for Soliris (eculizumab) to treat patients with neuromyelitis optica (NMO), a life-threatening, ultra-rare neurologic disorder.
Regulatory Affairs > News
EMA committee grants orphan designation for Apitope's ATX-F8-117 to treat haemophilia A
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) has granted orphan medicinal product designation to Apitope's ATX-F8-117 to treat patients with haemophilia A.
Regulatory Affairs > News
Valeant gets FDA approval for ONEXTON gel to treat acne vulgaris
Valeant Pharmaceuticals International has received approval from the Food and Drug Administration (FDA) for ONEXTON Gel (clindamycin phosphate and benzoyl peroxide), 1.2%/3.75%, for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older.
Regulatory Affairs > News
FDA extends review period for Novartis’ multiple myeloma investigational compound LBH589
By PBR Staff Writer
The US Food and Drug Administration (FDA) has extended the priority review period by up to three months for Novartis' new drug application (NDA) of LBH589 (panobinostat), a potent pan-deacetylase (pan-DAC) inhibitor, in combination with bortezomib and dexamethasone for patients with previously treated multiple myeloma.
Regulatory Affairs > News
Celgene gets positive CHMP opinion for OTEZLA to treat psoriasis and psoriatic arthritis
Celgene International Sàrl, a wholly-owned subsidiary of Celgene Corporation, announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OTEZLA (apremilast), the Company's oral selective inhibitor of phosphodiesterase 4 (PDE4), in two therapeutic indications:
Regulatory Affairs > News
Genzyme’s Cerdelga secures European CHMP positive opinion
By PBR Staff Writer
Genzyme has received positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommending approval of Cerdelga (eliglustat) capsules, an oral treatment for certain adults living with Gaucher disease type 1.
Regulatory Affairs > News
EMA CHMP issues positive opinion for Boehringer's nintedanib to treat IPF
By PBR Staff Writer
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Boehringer Ingelheim's nintedanib to treat patients with idiopathic pulmonary fibrosis (IPF).
Regulatory Affairs > News
FDA approves Purdue Pharma's Hysingla ER with abuse-deterrent properties
By PBR Staff Writer
The US Food and Drug Administration (FDA) has approved Purdue Pharma's Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment.
Regulatory Affairs > News
FDA grants fast track status for Merrimack's pancreatic cancer drug MM-398
By PBR Staff Writer
The US Food and Drug Administration (FDA) has granted fast track designation for Merrimack Pharmaceuticals' MM-398 (nanoliposomal irinotecan injection) to treat patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.
Regulatory Affairs > News
Gilead's hepatitis C drug Harvoni gets marketing authorization in Europe
By PBR Staff Writer
Gilead Sciences has received marketing authorization from the European Commission for Harvoni (ledipasvir 90mg/sofosbuvir 400mg), the first once-daily single tablet regimen to treat the majority of chronic hepatitis C genotype 1 and 4 infection in adults.
Regulatory Affairs > News
Kite Pharma gets positive opinion for orphan drug designation in Europe for cancer immunotherapy
Kite Pharma, a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT(TM)) products for the treatment of cancer, has announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending KTE-C19 for designation as an orphan medicinal product for the treatment of diffuse large B cell lymphoma (DLBCL).
Regulatory Affairs > News
Genentech gets FDA approval for Avastin to treat ovarian cancer
By PBR Staff Writer
Roche's subsidiary Genentech has received approval from the US Food and Drug Adminsitartion (FDA) for its Avastin in combination with chemotherapy to treat women with platinum-resistant, recurrent ovarian cancer.
Regulatory Affairs > News
1-15 of 2921 results