FDA Launches Pilot Program for Drug Supply-Chain Security
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The US Food and Drug Administration (FDA) has launched a new pilot program as part of its implementation of the Drug Supply Chain Security Act (DSCSA), a federal law that…

Cerbios, Olon, PCI Expand; Thermo Fisher, GE in Biomfg Pacts
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The latest news from contract development and manufacturing organizations, contract manufacturing organizations, and other suppliers featuring news from Cerbios-Pharma, Olon, Hovione, Thermo Fisher, GE Healthcare Life Sciences, and PCI Pharma…

J&J’s Janssen, MeiraGTx in $440-Million Gene-Therapy Product and Mfg Pact
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Janssen Pharmaceuticals, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has formed a worldwide collaboration and license agreement, worth up to $440 million, with MeiraGTx, a New York-…

Merck KGaA To Invest $70 Million in Massachusetts R&D Facility
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Merck KGaA has announced a $70-million investment to expand its research and development (R&D) facility in Billerica, Massachusetts. The new building will span 145,000 square feet and provide new laboratory…

Celgene, Triphase Accelerator in $980-Million Oncology Deal
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Celgene and Triphase Accelerator, a Toronto based oncology-focused drug-development company, together with FACIT, Triphase’s majority shareholder and a collaboration partner for research companies and investors, have formed a strategic collaboration…

GSK, Merck KGaA Form $4.2-Billion Immuno-Oncology Deal
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GlaxoSmithKline (GSK) and Merck KGaA have entered into a global strategic alliance, worth up to $4.2 billion, to jointly develop and commercialize M7824 (bintrafusp alfa), an investigational bifunctional fusion protein…

Eli Lilly, AC Immune in $1.9-Billion Deal for Alzheimer’s Disease
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Eli Lilly and Company and AC Immune SA, a Lausanne, Switzerland-based biopharmaceutical company, have formed an agreement to research and develop tau aggregation inhibitor small molecules for the potential treatment…

Akorn CEO Retires; Court OKs Terminated Merger with Fresenius
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Akorn, a Lake Forest, Illinois-headquartered specialty generic pharmaceutical company, has announced it will move forward as an independent company following a decision from the Supreme Court of the State of…

Cambrex, WuXi AppTec, Lonza Expand; Roquette Acquires Majority Stake in Excipient Manufacturer
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A roundup of the latest news from suppliers, contract development and manufacturing organizations, and contract manufacturing organizations, featuring Cambrex, WuXi AppTec, Lonza, and Roquette. Chemicals/Chemical API Manufacturing Cambrex Expands Analytical…

FDA Issues Guidances To Advance Biosimilars Policy Framework
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The US Food and Drug Administration (FDA) has released two guidances, one final and one draft, to advancie the agency’s biosimilars policy framework. The guidances describe the agency’s plan to…