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FDA announces strongest warnings for opioid pain medications

March 23, 2016
Medical Communications, Research and Development FDA, abuse, addiction, boxed, label, misuse, opioids, public health, restrictions, safety, warnings

The US Food and Drug Administration has announced class-wide safety labelling changes for immediate release (IR) opioid pain medications. The …

News
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NICE draft guidance says ‘no’ to cystic fibrosis drug Orkambi

March 23, 2016
Research and Development, Sales and Marketing NICE, Orkambi, Vertex, cystic fibrosis

NICE has issued draft guidance not recommending Vertex’s Orkambi (lumacaftor/ivacaftor) for use on the National Health Service (NHS) in England …

News
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Targeted cancer therapies can suppress T cell immune responses, study finds

March 23, 2016
Research and Development T cell, anti-cancer drugs, immunosuppresive, superagonist, wistar institute

Researchers at the Wistar Institute have developed a new method whereby targeted cancer therapies can provide appropriate therapeutics without supressing …

News
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Celyad teams-up with Institut Curie to advance its immuno-oncology program

March 22, 2016
Manufacturing and Production, Research and Development Cancer Immunotherapy, Celyad, Institut Curie, cellular immunotherapies

Celyad (Nasdaq: CYAD) on Tuesday said it has partnered with Institut Curie to develop its NKR-T pipeline in cellular immunotherapies …

News
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Eisai withdraws application for neurodegenerative-disease drug in Japan

March 22, 2016
Manufacturing and Production, Research and Development Eisai, mecobalamin, neurodegenerative disease

Pharma major Eisai (TYO: 4523) on Tuesday said the Japanese regulators have stalled the approval of its drug to treat …

News

BioMarin reports mixed Phase III results for genetic disorder trial-drug Pegvaliase

March 22, 2016
Manufacturing and Production, Research and Development

Biotech firm BioMarin Pharmaceutical (Nasdaq: BMRN) reported mixed results for its trial drug to treat genetic disorder phenylketonuria. Trial drug, …

News
cancer_cells

Darzalex to be trialled in combination with atezolizumab in multiple myeloma and solid tumours

March 22, 2016
Research and Development Genentech, Genmab, Janssen, Roche, atezolizumab, clnical trials, multiple myeloma, phase ib, solid tumours, tumour

Phase Ib clinical studies are set to begin, which will evaluate Darzalex (daratumumab) in combination with atezolizumab in a solid …

News

Raptor’s Procysbi gets Priority Review from Health Canada

March 22, 2016
Manufacturing and Production, Research and Development Canada, Health Canada, Procysbi, Raptor Pharmaceutical, genetic condition

Raptor Pharmaceutical (Nasdaq: RPTP) said Canadian regulators have accepted a priority review for its drug to treat a rare genetic …

News

23andMe’s apps to aid genetic research for Apple’s ResearchKit

March 22, 2016
Manufacturing and Production, Research and Development 23andME, Apple, genetics, research

Privately-held 23andMe has announced a new module for Apple’s (Nasdaq: AAPL) open source ResearchKit software framework that allows scientists to …

News
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Sosei appoints Peter Bains as COO and CEO-elect

March 22, 2016
Research and Development

Japan’s Sosei Group has announced the appointment of Syngene chief executive Peter Bains as representative executive officer and chief operating …

Appointment
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FDA bans clinical trial co-ordinator who faked patient samples and stole funds

March 22, 2016
Manufacturing and Production, Medical Communications FDA, HIV, clinical trials, faked, forgery, mcquerry, prison

The US Food and Drug Administration has permanently banned a clinical trial co-ordinator who was found to have falsified patient …

News
albumedix

Albumedix technology extends dosing interval in Behring haemophilia B drug

March 22, 2016
Manufacturing and Production, Research and Development Albumedix, GSK, Idelvion, Novozymes, VELTIS, haemophilia B

Novozymes subsidiary Albumedix has scored another big pharma tie-up for its albumin-based half-life extension technology VELTIS, which this time is …

News
disease

FDA approves new anthrax treatment

March 22, 2016
Manufacturing and Production, Research and Development Antibacterial, FDA, US, anthim, anthrax, defense, inhalational

The US Food and Drug Administration (FDA) has approved Anthim (obiltoxaximab) to treat inhalational anthrax in combination with appropriate antibacterial …

News
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Takeda presents long-term Entyvio data in CD and UC

March 21, 2016
Manufacturing and Production, Research and Development Crohn's, Crohn's and Colitis, Entyvio, Takeda, ulcerative colitis

Japan’s Takeda has presented interim findings from the GEMINI Long-Term Safety (LTS) study of ulcerative colitis drug Entyvio (vedolizumab) at …

News

ThromboGenics signs €1m licensing deal with Galapagos for diabetic eye disease treatment

March 21, 2016
Manufacturing and Production, Research and Development, Sales and Marketing

ThromboGenics NV (Euronext Brussels: THR) on Monday said it has signed a €1 million license deal with Galapagos NV (Nasdaq: …

News
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European Medicines Agency elects Christa Wirthumer-Hoche as new chair of management board

March 21, 2016
Medical Communications, Research and Development Christa Wirthumer-Hoche, EMA, European Medicines Agency, chair, chairperson, wirthumer-hoche

Christa Wirthumer-Hoche has been elected chair of the management board of the European Medicine’s Agency. She has served as vice …

Appointment
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Leo Pharma gets EU scientific approval for its psoriasis drug Enstilar

March 21, 2016
Business Services, Research and Development, Sales and Marketing EU, Enstilar, LEO Pharma, psoriasis vulgaris

Leo Pharma on Monday said its drug to treat inflammatory skin condition has received scientific approval in the European Union. …

News
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Valeant CEO Pearson to leave company

March 21, 2016
Michael Pearson, Valeant

Valeant (NYSE:VRX) has announced that it has begun the search for a new CEO, confirming that Michael Pearson is to …

News
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AstraZeneca buys rights to Orexo respiratory programme

March 21, 2016
Sales and Marketing AstraZeneca, COPD, asthma, orexo

AstraZeneca has bought the rights to a respiratory programme from Sweden’s Orexo for $5 million. The deal centres on the …

News
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Novartis’s heart failure drug given final recommendation by NICE

March 21, 2016
Manufacturing and Production, Research and Development Entresto, NICE, Novartis, approval, draft, guidance, heart failure, heart failure drug

The National Institute for Health and Care Excellence (NICE) has issued its final guidance on Entresto (sacubritil/valsartan), a heart failure …

News
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