regulation
Final Nice appraisal says no to cystic fibrosis drug, Orkambi
June 17, 2016Medical Communications NICE, Orkambi, Vertex Pharma, cystic fibrosis, recommendation, regulation
The National Institute for Health and Care Excellence (Nice) has issued a final appraisal determination rejecting cystic fibrosis drug, Orkambi …
Sobi says US FDA approves higher dose of Orfadin to treat rare genetic disorder
June 15, 2016Research and Development, Sales and Marketing US FDA, genetic disorder, regulation, sobi
Swedish Orphan Biovitrum AB (Sobi) on Wednesday said the US Food and Drug Administration (FDA) has approved a higher strength …
Nice says Bayer’s Eylea not recommended as first-line treatment in draft recommendation
June 10, 2016Medical Communications, Research and Development Bayer, Eylea, NICE, recommendation, regulation
The National Institute for Health and Care Excellence (Nice) in a provisional guidance said Bayer’s (ETR: BAYN) Eylea (aflibercept) is …
AstraZeneca says latest study data for Lynparza suggest improvement in overall survival in ovarian cancer
June 7, 2016Manufacturing and Production, Research and Development, Sales and Marketing ASCO, AstraZeneca, NHS, lynparza, ovarian cancer, regulation
UK drugmaker AstraZeneca (LSE: AZN) said mid-stage trials for Lynparza (olaparib) maintenance therapy suggest an improvement in overall survival (OS) …
Novartis’ Afinitor gets EU approval to treat cancerous gastrointestinal or lung tumors
June 2, 2016Research and Development, Sales and Marketing Afinitor, Cancer, European Commission, Novartis, regulation
Swiss drugmaker Novartis (VTX: NOVN) on Thursday said the European Commission has approved its Afinitor (everolimus) to treat cancerous gastrointestinal …
GSK’s gene therapy Strimvelis gets European regulatory nod
June 1, 2016Research and Development, Sales and Marketing EU, European Commission, GlaxoSmithKline, Strimvelis, gene therapy, regulation
UK drugmaker GlaxoSmithKline (LSE: GSK) said its gene therapy Strimvelis has secured backing from the European regulators. The European Commission …
FDA asks Teva for further study on Huntington drug candidate
June 1, 2016Medical Communications, Research and Development Huntington disease, Teva, US FDA, regulation
Israel-based Teva Pharmaceutical Industries (NYSE: TEVA) said the US regulators have put on hold the approval for its drug to …
AbbVie, Janssen’s Imbruvica gets European approval to teat CLL
May 31, 2016Manufacturing and Production, Research and Development, Sales and Marketing AbbVie, CLL, drug trial, regulation
AbbVie (NYSE: ABBV) on Tuesday said Imbruvica (ibrutinib) has secured European regulatory backing to treat chronic lymphocytic leukemia or CLL. …
EU green-lights Samsung Bioepis, Biogen’s Remicade biosimilar Flixabi
May 31, 2016Manufacturing and Production, Research and Development, Sales and Marketing Biogen, Samsung Bioepis, biosimilar, drug trial, regulation, research
Samsung Bioepis and partner Biogen (Nasdaq: BIIB) said the European Commission has approved Flixabi, a biosimilar version of Johnson & …
Roche’s MabThera gets European approval to treat chronic lymphocytic leukaemia
May 31, 2016Manufacturing and Production Roche, chronic lymphocytic leukaemia, drug approval, regulation
Swiss drugmaker Roche (SIX: ROG) on Tuesday said the European Commission (EC) has approved the subcutaneous (SC) formulation of its …
AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA
May 27, 2016Medical Communications, Research and Development AstraZeneca, NDA, US FDA, regulation
UK pharma firm AstraZeneca (LSE: AZN) on Friday said the US Food and Drug Administration (FDA) has issued a complete …
Focus: Regulators Enter the Drug Pricing Debate
May 24, 2016Manufacturing and Production, Research and Development, Sales and Marketing Drug pricing, pharma industry, regulation
By Anjali Shukla The Chinese authorities have come down strongly on the issue of drug costs, slashing the prices of …
US FDA advisors question usefulness of Sanofi’s combination diabetes therapy
May 24, 2016Manufacturing and Production, Research and Development, Sales and Marketing Sanofi, US FDA, diabetes, drug trial, regulation
US Food and Drug Administration staff questioned the benefits of French drugmaker Sanofi’s (Euronext: SAN) diabetes drug candidate as well …
Novartis’ heart failure drug Entresto gets top US, EU recommendation
May 23, 2016Research and Development, Sales and Marketing Ernesto, Novartis, heart failure, regulation
Swiss drugmaker Novartis (VTX: NOVN) said its heart failure drug Entresto (sacubitril/ valsartan) has secured top recommendations in the US …
Nice backs Novartis’ lung cancer drug
May 20, 2016NHS, NICE, Novartis, ceritinib, lung cancer, recommendation, regulation
The National Institute for Health and Care Excellence (Nice) has recommended Novartis’ (VTX: NOVN) Ceritinib (zykadia) as a treatment for …
