Eugene

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LATEST

Sanofi, Abbott, Medtronic, Novo Nordisk Partner for Digital Solutions for Insulin Delivery
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Sanofi and Novo Nordisk are partnering in separate deals for insulin delivery. Sanofi and Abbott are partnering to integrate glucose sensing and insulin-delivery technologies. Novo Nordisk and Medtronic are collaborating…

FDA Issues Final Guidance on Use of Citizens Petitions in Drug-Approval Process
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The US Food and Drug Administration (FDA) has issued a final guidance, Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and…

Lundbeck To Acquire Alder Biopharma in $1.95-Billion Deal
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H. Lundbeck, a Valby, Denmark-based pharmaceutical company, has agreed to acquire Alder Biopharmaceuticals, a Bothell, Washington-based clinical-stage biopharmaceutical company developing therapeutic antibodies for treating migraines, in a deal worth up…

EMA Initiates Review of Nitrosamine Impurities in Ranitidine; To Develop Guidance for APIs
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As part of its investigation of nitrosamine impurities in certain active pharmaceutical ingredients (APIs), the European Medicines Agency’s (EMA) Executive Director Guido Rasi has asked the EMA’s Committee for Medicinal…

FDA Reports Nitrosamine Impurity in the API Ranitidine
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The US Food and Drug Administration (FDA) reports that it has found that some medicines with the active pharmaceutical ingredient (API), ranitidine, contain a nitrosamine impurity, N-nitrosodimethylamine (NDMA) at low…

Purdue Pharma in $10-Billion-Plus Opioid Settlement; Files for Bankruptcy
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Purdue Pharma has reached an agreement of more than $10 billion for settling opioid litigation. The agreement covers litigation facing the company with 24 state attorneys general, analogous officials from…

AbbVie Pulls Phase III Lung-Cancer Drug; FDA OKs Kyowa Kirin’s Parkinson’s Drug
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AbbVie Terminates ADC Drug Candidate Rova for Lung Cancer AbbVie reports that that Meru, a Phase III trial evaluating Rova-T (rovalpituzumab tesirine), a therapy for treating advanced small-cell lung cancer,…

Albemarle Fine Chemistry Services and Particle Dynamics Expand
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The latest news from CDMOs, CMOs, and suppliers featuring news from Albemarle Fine Chemistry Services and Particle Dynamics. Chemicals/Chemical API Manufacturing Albemarle Fine Chemistry Services Expands With New Operations Building…

Global Pharma Briefs: News from Asia, the Middle East and the United States
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A roundup of developments and latest news from Israel (BiomX), India (Sanofi), and United States (Aurobindo, Novo Nordisk) Israel BiomX Completes Construction of Clinical Phage Mfg Facility in Israel BiomX,…

GSK To Acquire Sitari Pharmaceuticals From Early-Stage Life-Sciences Venture Pact
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GlaxoSmithKline (GSK) has agreed to acquire Sitari Pharmaceuticals, a company developing treatments for celiac disease, from Avalon Ventures, a venture-capital firm. Sitari was the first company formed under a GSK–Avalon…