Research and Development

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Novo Nordisk presents positive long-term results for Saxenda

June 3, 2016 Medical Communications, Research and Development Novo Nordisk, cardiometabolic risk factors, liraglutide, saxenda, weight loss

Novo Nordisk has presented analysis covering three years of a late-stage trial for Saxenda (liarglutide 3mg) , which showed the …
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Shire completes Baxalta takeover

June 3, 2016 Medical Communications, Research and Development, Sales and Marketing Baxalta, Shire, deal, merger and acquisition, revenue, sales

UK drugmaker Shire (LSE: SHP) on Friday announced the completion of merger with rare disease specialist Baxalta (NYSE: BXLT).  The …

Bayer, Orion to start Phase III trials for prostate cancer drug

June 3, 2016 Medical Communications, Research and Development, Sales and Marketing Bayer, drug trial, orion, prostate cancer, research

German pharma and crop sciences giant Bayer (ETR: BAYN) and Orion Corp (Nasdaq Helsinki: ORNAV) have agreed to start a Phase …

New FDA expanded access guidelines spell trouble for Sarepta

June 2, 2016 Medical Communications, Research and Development, Sales and Marketing Duchenne Muscular Dystrophy, Eteplirsen, FDA, compassionate grounds, sarepta

New guidelines intended to streamline the process of expanded access to medicines by the US Food and Drug Administration (FDA) …
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Biogen Alzheimer’s treatment accepted into EMA’s PRIME scheme

June 2, 2016 Research and Development, Sales and Marketing Alzheimer's, Biogen, EMA, PRIME, accelerated approval

Biogen (NASDAQ: BIIB) has announced that the European Medicines Agency (EMA) has accepted its investigational treatment for Alzheimer’s disease, aducanumab, …
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Global oncology market to reach $150 billion by 2020, says IMS Health

June 2, 2016 Research and Development IMS Health, annual global growth, cancer drugs, oncology

Global sales of oncology drugs rose to $107 billion in 2015, according to a new IMS Health report, with growth …

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 …
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Phase III trials to start in Novartis/Genmab multiple sclerosis collaboration

June 2, 2016 Research and Development Arzerra, Genmab, Novartis, multiple sclerosis, ofatumumab, phase III

Genmab (NASDAQ: GEN) has announced that its collaboration partner, Novartis, is set to initiate Phase III trials for ofatumumab in …
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Janssen says its Trevicta gets European regulatory approval as maintenance therapy for Schizophrenia

June 2, 2016 Medical Communications, Research and Development European Commission, Janssen, Trevicta, schizophrenia

Janssen said the European Commission has approved its Trevicta (paliperidone palmitate, a 3‑monthly injection) as maintenance treatment of schizophrenia.  Trevicta …

Nice rejects Janssen’s Imbruvica in draft guidance

June 1, 2016 Medical Communications, Research and Development

The UK regulators have not recommended Janssen’s leukaemia drug Imbruvica (ibrutinib) to treat in draft guidance. The National Institute for …
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Biogen says European regulatory committee adopts positive view for Tysabri

June 1, 2016 Medical Communications, Research and Development, Sales and Marketing Biogen, CHMP, EMA, Tysabri, multiple sclerosis

Biogen (Nasdaq: BIIB) said the European regulatory committee has backed the approval of a variation to the marketing authorization for its …

Biomarin withdraws regulatory submissions for Duchenne muscular dystrophy drug

June 1, 2016 Research and Development, Sales and Marketing BioMarin, Duchenne Muscular Dystrophy, EMA, FDA, Kyndrisa, failure, rejection

Biomarin (NASDAQ: BMRN) has announced that it has withdrawn its marketing authorisation application for Duchenne muscular dystrophy drug, Kyndrisa (drisapersen), …
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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 …

FDA approves Lilly/Boehringer Ingelheim type-2 diabetes drug

June 1, 2016 Research and Development, Sales and Marketing Boehringer Ingelheim, Eli Lilly, FDA, diabetes, jentadueto, jentadueto xr, lilly, partnership, type 2, type-2

The US Food and Drug Administration (FDA) has approved Jentadueto XR (linagliptin and metformin hydrochloride extended release) tablets for the …
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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 …
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