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Showing 15 posts of 68 posts found.

Final Nice appraisal says no to cystic fibrosis drug, Orkambi

June 17, 2016
Medical 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 …

News
sobi

Sobi says US FDA approves higher dose of Orfadin to treat rare genetic disorder

June 15, 2016
Research 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 …

News

Nice says Bayer’s Eylea not recommended as first-line treatment in draft recommendation

June 10, 2016
Medical 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 …

News
astrazeneca_plaque

AstraZeneca says latest study data for Lynparza suggest improvement in overall survival in ovarian cancer

June 7, 2016
Manufacturing 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) …

News

Novartis’ Afinitor gets EU approval to treat cancerous gastrointestinal or lung tumors

June 2, 2016
Research 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 …

News
gsk_l_rgb

GSK’s gene therapy Strimvelis gets European regulatory nod

June 1, 2016
Research 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 …

News
teva_copy

FDA asks Teva for further study on Huntington drug candidate

June 1, 2016
Medical 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 …

News
imbruvica_logo

AbbVie, Janssen’s Imbruvica gets European approval to teat CLL

May 31, 2016
Manufacturing 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. …

News
samsung_bioepis

EU green-lights Samsung Bioepis, Biogen’s Remicade biosimilar Flixabi

May 31, 2016
Manufacturing 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 & …

News

Roche’s MabThera gets European approval to treat chronic lymphocytic leukaemia

May 31, 2016
Manufacturing 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 …

News

AstraZeneca says NDA for drug to treat hyperkalaemia gets observations from the US FDA

May 27, 2016
Medical 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 …

News

Focus: Regulators Enter the Drug Pricing Debate

May 24, 2016
Manufacturing 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 …

Feature

US FDA advisors question usefulness of Sanofi’s combination diabetes therapy

May 24, 2016
Manufacturing 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 …

News
novartis_outside_1

Novartis’ heart failure drug Entresto gets top US, EU recommendation

May 23, 2016
Research 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 …

News
novartis_side_building

Nice backs Novartis’ lung cancer drug

May 20, 2016
NHS, 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 …

News
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