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Bristol-Myers Squibb presents Opdivo data at ASCO

June 6, 2016
Research and Development, Sales and Marketing ASCO, Bristol-Myers Squibb, opdivo

Bristol-Myers Squibb (NYSE: BMY) has presented a wide range of results on Opdivo (nivolumab) in a range of oncology indications …

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Janssen says combination Phase III study for immunotherapy Darzalex for multiple myeloma shows significant PFS

June 6, 2016
Research and Development, Sales and Marketing ASCO, Drig Trial, Janssen, multiple myeloma

Janssen said combination late stage trials for its immunotherapy drug to treat multiple myeloma showed 61% progression-free survival.  The company …

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Roche says Phase III trials for giant cell arteritis drug met primary endpoint

June 6, 2016
Research and Development, Sales and Marketing Roche, arthritis, drug trial

Cancer drugmaker Roche (SIX: ROG) said late stage trials for its drug to treat giant cell arteritis (GCA) met its …

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Sanofi and Regeneron combo shows superiority in late-stage atopic dermatitis trials

June 6, 2016
Research and Development, Sales and Marketing Dupilumab, Regeneron, Sanofi, atopic dermatitis, late stage trials

Sanofi (NYSE: SNY) and Regeneron (NASDAQ: REGN) have announced positive results from a Phase III trial evaluating dupilumab in patients …

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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 …

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Eisai partners with Novartis in renal cell carcinoma collaboration

June 3, 2016
Medical Communications, Sales and Marketing Afinitor, Eisai, Lenvima, Novartis, US, everolimus, lenvatinib mesylate

Eisai (TYO: 4523) has announced that it has entered into a partnership with Novartis Pharmaceuticals to collaborate on commercial and …

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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 …

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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 …

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AstraZeneca licenses gout drug Zurampic to Grünenthal in Europe and Latin America

June 2, 2016
Business Services, Manufacturing and Production, Sales and Marketing AstraZeneca, Grunenthal, Licencing, Zurampic, gout, sales

UK drugmaker AstraZeneca (LSE: AZN) on Thursday said it has entered into a licensing agreement worth up to $230 million …

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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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Sanofi looks to set date for showdown with Medivation shareholders

June 2, 2016
Sales and Marketing Medivation, Sanofi, hostile, record date, shareholders, takeover

Sanofi (NYSE: SNY) has announced that it has attempted to fix a record date with Medivation (NASDAQ: MDVN) where the …

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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 …

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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 …

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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 …

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