Teva Leads Pipeline News
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A roundup of the latest market developments from the pipelines of the pharmaceutical majors, featuring news from Teva Pharmaceutical Industries. Editor’s Note: This article was updated on a continuous basis…

US House Committee Raises Concerns to FDA Over Heparin Supply
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The US House of Representatives’ House Energy and Commerce (E&C) Committee has sent a letter to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb asking the agency to review…

EMA Revises Draft Guideline for Advanced Therapy Medicinal Products
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The European Medicines Agency (EMA) has released a draft revised guideline on the safety and efficacy follow-up and risk management of advanced therapy medicinal products (ATMPs), which are medicines based…

EC Report Finds Inconsistent Penalties for Falsified Medicines in EU
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A report from the European Commission (EC) has found a wide variation in penalties across the European Union (EU) for circulation of falsified medicines.The report analyzes implementation of the European…

CDER, CBER Outline Five-Year Data Standards Strategy
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The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have released their shared data standards strategy for…

Marchesini Group Invests in 3D Printing, Serialization
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The Marchesini Group, a Bologna, Italy-headquartered pharmaceutical packaging company, has acquired a 48% stake in SEA Vision, a Pavia, Italy-headquartered creator of vision and inspection systems used in quality control…

FDA Acquires GEA Development Unit for Continuous Manufacturing
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The US Food and Drug Administration (FDA) has purchased from GEA, a Düsseldorf, Germany-headquartered equipment manufacturer, a ConsiGma 1 OSD development unit, to be housed in the FDA’s Center for…

Rentschler Biopharma Appoints COO
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Rentschler Biopharma, a Laupheim, Germany-headquartered contract development and manufacturing organization (CDMO) for biopharmaceuticals, has appointed Dr. Ralf Otto as chief operating officer (COO), effective February 1, 2018. Otto succeeds Thomas…

CDMO CorePharma Under New Ownership
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A group of industry investors has acquired CorePharma, a Middlesex, New Jersey-headquartered specialty generic pharmaceutical developer and manufacturer, including its facilities and equipment from Impax Laboratories, a Hayward, California-based specialty…

Agilent Partners with Science Exchange
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Agilent Technologies, a Santa Clara, California-headquartered service provider for life sciences, diagnostics, and applied chemical markets, has partnered with Science Exchange, a Palo Alto, California-headquartered enterprise platform for outsourced research…