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Showing 15 posts of 9616 posts found.

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 …
News

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) …
News
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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, …
News
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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 …
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
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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 …
News
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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 …
News

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 …
News
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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 …
News

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), …
News
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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 …
News

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 …
News
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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 …
News
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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
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Roche launches Bluetooth-enabled self-testing device to check blood clotting in EU

May 31, 2016 Manufacturing and Production, Research and Development, Sales and Marketing HealthTech, Heart Conditions, Roche, blood clotting, product launch

Swiss drug firm Roche (Six: ROG) has launched a blood-clott monitoring system for patients with different heart conditions. The CoaguChek …
News
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