Manufacturing and Production

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Mylan launches generic of Valeant’s Ultram in the US

March 29, 2016 Manufacturing and Production, Sales and Marketing FDA, Mylan, Valeant, abbreviate new drug application, generic, pain, tramadol, ultram

Mylan (NASDAQ, TASE: MYL) has announced the launch of its generic version of Valeant’s Ultram tablets in the US. The …
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Gilead must pay MSD $200m in hep C drug patent case

March 29, 2016 Manufacturing and Production, Sales and Marketing Gilead Sciences, MSD, Solvadi, harvoni

A Californian federal jury has ordered Gilead Sciences to pay MSD and Ionis $200 million for infringing on patents relating …
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PTC Therapeutics to cut jobs after FDA rejects Duchenne drug

March 24, 2016 Manufacturing and Production Duchenne Muscular Dystrophy, PTC Therapeutics

PTC Therapeutics has announced plans to reduce its operating expenses that will see it cut almost a fifth of its …

PCI Pharma Services’ Hay-on-Wye site launches specialist packaging design department

March 23, 2016 Manufacturing and Production

Leading pharmaceutical outsourcing provider PCI Pharma Services has launched Technical Services, a new packaging design and development function, at its …
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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 …
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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 …

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, …

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 …

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 …
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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 …
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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 …
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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 …
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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 …

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: …
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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 …
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