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FDA Grants Breakthrough Therapy Designation for BioMarin’s Valoctocogene Roxaparvovec

Oct 26, 2017
BioMarin Pharmaceutical announced that the U.S. Food and Drug Administration (FDA) granted valoctocogene roxaparvovec (formerly BMN 270) Breakthrough Therapy Designation. The FDA's…
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PDL BioPharma proposes to acquire Neos Therapeutics

Oct 26, 2017
PDL BioPharma announced that it has submitted a proposal to acquire Neos Therapeutics for $10.25per share in cash. This all-cash transaction represents a premium of 40% to the…
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Artemis Therapeutics appoints Brian M. Culley as CEO

Oct 26, 2017
Artemis Therapeutics announced the appointment of Brian M. Culley, M.A., M.B.A. as its Chief Executive Officer. Mr. Culley is an entrepreneurial and innovative biotech executive with 25…
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Incyte and MacroGenics Announce Global Collaboration and Licensing Agreement

Oct 26, 2017
Incyte Corporation and MacroGenics, Inc. announced that the companies have entered into an exclusive global collaboration and license agreement for MacroGenics’ MGA012, an…
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Ortek Therapeutics receives FDA clearance for ECD Device

Oct 25, 2017
Ortek Therapeutics announced that the Ortek ECD™ received 510(k) clearance from the U.S. Food and Drug Administration. The ECD is a patented lightweight tabletop device designed as an…
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TiGenix granted Orphan Drug Designation from the U.S. FDA for Cx601

Oct 24, 2017
TiGenix NV announces that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to Cx601 for the treatment of patients with fistulizing Crohns disease.…
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Imprimis Pharmaceuticals to Offer Compounded Cyclosporine Alternative to Restasis

Oct 24, 2017
Imprimis Pharmaceuticals announced that it is making compounded Cyclosporine-based formulations available for physicians to consider prescribing as customizable and potentially…
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Catalent Completes Acquisition of Cook Pharmica

Oct 24, 2017
Catalent announced that it has completed the acquisition of Cook Pharmica LLC, an integrated provider of drug substance and drug product manufacturing and related services. The…
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Recipharm equips Lisbon facility for US and European serialisation

Oct 24, 2017
Recipharm has equipped its sixth facility with serialisation capabilities ahead of the US and European regulation enforcement deadlines. The facility in Lisbon is the latest of…
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Vetter to Expand Its Secondary Packaging Service Capacity to Meet Rising Demands

Oct 23, 2017
Vetter announced a major expansion of its secondary packaging capacities as a response to rising customer needs and market demands for complex packaging solutions. The need for…
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