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Mylan to buy global marketing rights of Mapi’s Glatiramer acetate product Mylan has agreed to acquire global marketing rights of Israel-based Mapi Pharma’s GA Depot, a long-acting once-monthly Glatiramer acetate product.
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Ionis licenses to Akcea global rights to inotersen in $1.7bn deal By PBR Staff Writer
Ionis Pharmaceuticals has licensed to Akcea Therapeutics worldwide rights to inotersen and AKCEA-TTR-LRx, formerly IONIS-TTR-LRx, in a transaction potentially worth about $1.7bn.
Contract Research & Services > Contract Services > News Valeant, Kaken sign license deal to develop new chemical entity for psoriasis Valeant Pharmaceuticals International's subsidiary and Kaken Pharmaceutical have entered into a license agreement to develop and commercialize products featuring KP-470, an investigational compound for the topical treatment of psoriasis.
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THE FUTURE OF THE PHARMACEUTICAL INDUSTRY
| By NSF International
YOUR CHANCE TO CONTRIBUTE by Martin Lush Ever participated in one of those benchmarking exercises? You know what I mean. When a (usually) fresh-faced consultant asks lots of questions and fills in a spreadsheet comparing what you do with your competitors. Well, beware.
Contract Research & Services > Contract Services > White Papers
REVIEW OF EU ATMP GMP GUIDANCE
| By NSF International
On November 22, 2017, the EU Commission adopted the Guidelines on Good Manufacturing Practice specific to advanced therapy medicinal products (ATMPs), as Part IV of EudraLex Volume 4. These guidelines come into force on May 22, 2018. When these GMP guidelines for ATMPs were first drafted, most of the manufacturers of ATMPs were critical of the guidelines being a separate guidance document rather than being an annex to the existing guidelines in EudraLex Volume 4. There were also criticisms from smaller academic and hospital units that the new guidelines place too much burden on these units in their rigid application of industrial type GMPs, which they argued was not practicable to these highly innovative products. Concern was also expressed that as the initial draft stood, the innovative research that was going on with ATMPs would be hindered in the EU.
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