Omyapharm® for enhanced ODTs

Jun 12, 2018

Study findings underline the pleasant mouthfeel and excellent technical properties of the high purity mineral excipient In a recent study, scientists confirmed the ability of Omyapharm® to formulate orally disintegrating tablets (ODTs) with enhanced mouthfeel and examined their acceptability among healthy volunteers. The multifunctional excipient from Omya is a highly structured mineral based on calcium carbonate and calcium phosphate. The study found that the tablets were well accepted by the volunteers and – in correlation with the in vitro model – disintegrated fast in vivo. Additionally, the compactibility and the physical stability of the tablets were preserved, delivering the high ...

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Healios receives rights to develop and commercialize additional indications and Athersys receives $20 million in license fees, plus potential milestones payments and royalties

Jun 12, 2018

Discussions extended for China and other rights Athersys, Inc. (NASDAQ:ATHX) announced today that it has entered into an agreement with HEALIOS K.K. (“Healios”) to expand their collaboration into additional therapeutic areas. Under the terms of the agreements, Healios obtained exclusive licenses for the development and commercialization in Japan of MultiStem® therapy for the treatment of acute respiratory distress syndrome (“ARDS”) and of MultiStem cells used in combination with iPSC-derived cells for the treatment of certain organs. Healios also received an exclusive global license to develop and commercialize MultiStem cells, either as a standalone therapy or in combination with retinal pigmented epithelial ...

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Countdown begins to the UK’s leading Processing & Packaging Machinery event

Jun 12, 2018

The PPMA Show to celebrate its 30th anniversary at the NEC Birmingham 25-27 September 2018  Celebrating its 30th anniversary this year, the PPMA Show will return to the NEC Birmingham from 25-27 September 2018 to showcase the latest innovations in smart manufacturing, processing technology and packaging machinery, aimed to increase production line efficiencies and enhance business performance and profitability.   New to the show this year will be the Enterprise Zone, which will offer visitors a focal point for learning, networking, discovery and live debate. Presenting the biggest and most comprehensive line-up of production technologies and solutions for the food and ...

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FDA Announces Policies to Facilitate Development of Generic Drugs

Jun 12, 2018

Commissioner outlines new policies for drugs that have Risk Evaluation and Mitigation Strategy (REMS) requirements. In a recent statement, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb introduced new agency policies to address challenges faced by generic drug manufacturers looking to introduce new generics for branded drugs that have Risk Evaluation and Mitigation Strategy (REMS) requirements. Gottlieb discussed two different tactics used by branded drug makers to delay the introduction of these types of generics. Drugs with REMS requirements have serious risks associated with them, and as such FDA requires drug makers to develop REMS to ensure that the ...

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LABCORP EXPANDS DRUG DEVELOPMENT SOLUTIONS WITH ACQUISITION OF SCIFORMIX

Jun 12, 2018

Sciformix extends Covance’s pharmacovigilance capabilities for post-approval safety solutions LabCorp® (NYSE: LH), a leading global life sciences company, announced today that it has acquired Sciformix Corporation, a scientific process outsourcing company focused on pharmacovigilance and regulatory solutions for biopharmaceutical and medical devices clients. Sciformix will become part of Covance, LabCorp’s drug development business. “This acquisition strengthens our position in the later phases of drug and device development, particularly for post-marketing pharmacovigilance and market access solutions,” said David P. King, chairman and chief executive officer of LabCorp. “The addition of Sciformix’s scientific and technology expertise, combined with its quality-driven processes, will ...

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