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Shionogi Announces FDA Approval of Mulpleta (Lusutrombopag)

Aug 3, 2018
Shionogi & Co., Ltd. announced that, after completing a Priority Review, the U.S. Food and Drug Administration (FDA) has approved Mulpleta (lusutrombopag), a once-daily, orally…
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Abdi Ibrahim selects rfxcel for FMD compliance

Aug 2, 2018
Abdi Ibrahim has carefully selected rfxcel to implement and support new compliance management and serialisation processing software to ensure full compliance with current and future…
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Torque Introduces High-efficiency T cell Manufacturing Process

Aug 2, 2018
Torque, an immuno-oncology company developing first-in-class Deep Primed T Cell Therapeutics to direct immune power deep within the tumor microenvironment, announced today a…
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Forge Therapeutics Achieves CARB-X Milestone

Aug 2, 2018
Forge Therapeutics, Inc. (Forge), a biotechnology company developing novel medicines targeting metalloenzymes, announced that, based on achievement of technical milestones, it has…
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Nutriband Inc. Completes Acquisition of 4P Therapeutics Inc.

Aug 2, 2018
Nutriband Inc announced the formal completion of the acquisition of Atlanta-based 4P Therapeutics Inc. Pursuant to the previously announced acquisition agreement, on Aug 1, 2018,…
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IATA’s CEIV-Pharma Certification or HSA’s GDP Certification?

Aug 2, 2018
Players throughout the pharmaceutical supply chain are experiencing growing pressure to gain accreditation for handling the high-value, temperature-sensitive cargo, as having a…
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Industry news with an exclusive interview from Aerie Pharmaceuticals for Ophthalmic Drugs 2018

Aug 1, 2018
SMi are delighted to have interviewed Mitchell de Long, Vice President, Chemistry, Aerie Pharmaceuticals regarding his thoughts and experiences within the ophthalmology space.…
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Talks from the MHRA, Innovate UK, Plasticell and more at SMi’s Cell & Gene Therapy conference

Aug 1, 2018
The lengthening shadow of increase in health spending in the coming years is sharpening the minds of legislators, regulators and payers alike. The growing time-to-market, the rising…
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Puma Biotechnology Files New Drug Submission for NERLYNX in Canada

Aug 1, 2018
Puma Biotechnology announced that Health Canada has accepted for review the Company’s New Drug Submission (NDS) for the medicinal product NERLYNX (neratinib) for the extended adjuvant…
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LEO Pharma to Expand Its Lead in Medical Dermatology with Acquisition of Bayer’s Prescription…

Aug 1, 2018
LEO Pharma and Bayer announced that LEO Pharma has entered into a definitive agreement to buy Bayer’s global prescription dermatology unit. The portfolio to be acquired includes branded…
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