WuXi STA, Regulus in Pact for Oligonucleotides Mfg
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STA Pharmaceutical Co., a WuXi AppTec subsidiary focused on small-molecule pharmaceutical development and manufacturing, and Regulus Therapeutics, a San Diego, California-headquartered biopharmaceutical company focused on microRNA-targeting drugs, have entered into…

FDA Issues Draft Guidance for Implementing Drug Supply Chain Security Act
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The US Food and Drug Administration (FDA) has issued two draft guidances to further the agency’s implementation of the Drug Supply Chain Security Act (DSCSA), which outlines steps to build…

AstraZeneca Launches New Biopharm Company Viela Bio
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AstraZeneca has announced that its global biologics research and development arm, MedImmune, is spinning out six molecules from its early-stage inflammation and autoimmunity programs into an independent biotech company, Viela…

DowDuPont Names Its Three Planned Spin-off Companies
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As part of a post-merger plan, DowDuPont has announced the corporate brand names that each of its divisions plans to assume once they are separated as independent companies. DowDuPont plans…

Lilly Leads Drug Approval News
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A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Eli Lilly and Company. Editor’s Note: This article was updated on a continuous basis for news…

Shire, Allergan, and Pfizer Lead Pipeline News
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A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Shire, Allergan, Pfizer, AstraZeneca and Merck & Co., and Amgen. Editor’s Note: This…

Amgen Loses Court Ruling with FDA Over Pediatric Exclusivity for Blockbuster Drug Sensipar
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Amgen has suffered a setback in seeking pediatric exclusivity for its blockbuster drug, Sensipar (cinacalcet hydrochloride), a calcium-reducer, as it faces generic-drug competition. A federal district court has ruled in…

CapsCanada Invests $28 Million for New Capsule Manufacturing Facility
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CapsCanada, a Windsor, Ontario, Canada-headquartered provider of capsules for pharmaceuticals and dietary supplements, has invested $28 million to add a new 100,000-square-foot manufacturing facility for hydroxypropyl methylcellulose (HPMC) capsules. With…

Marken Appoints VP of QA
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Marken, a Research Triangle Park, North Carolina-based provider of logistics and supply-chain services for clinical trial materials, has appointed Navnit Patel, PhD, as vice president, global quality assurance, effective March…

Recipharm CFO Resigns
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Recipharm, a Jordbro, Sweden-based contract development and manufacturing organization, has announced that its chief financial officer (CFO), Henrik Stenqvist, has resigned. He will serve as CFO until later in the…