ANI Pharma Acquires CDMO WellSpring Pharma for $18 Million
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ANI Pharmaceuticals, a Baudette, Minnesota-headquartered specialty pharmaceutical company, has acquired WellSpring Pharma Services, an Oakville, Canada-headquartered contract development and manufacturing organization (CDMO) of drug products, for $18 million in cash.…

Pfizer, Antares Pharma Partner to Develop Combination Drug Rescue Pen
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Pfizer has formed a deal with Antares Pharma, an Ewing, New Jersey-based pharmaceutical company, to develop a combination drug-device rescue pen. This rescue pen will use the Antares QuickShot auto…

Regeneron Takes $100 Million Equity Stake in bluebird bio; To Develop Cancer Cell Therapies
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Regeneron Pharmaceuticals, a Tarrytown, New York-based biopharmaceutical company, and bluebird bio, a Cambridge, Massachusetts-based clinical-stage gene-therapy company, have partnered to apply their technology platforms to the discovery, development, and commercialization…

FDA OKs First Generic Under Pathway to Support Competition for Sole-Source Drugs
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The US Food and Drug Administration (FDA) has approved the first generic drugs to receive a competitive generic therapy (CGT) designation. This new approval pathway by the FDA was created…

EC OKs Pfizer’s Biosimilar of Roche’s Blockbuster Drug Herceptin
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The European Commission (EC) has approved Pfizer’s Trazimera (trastuzumab), a biosimilar to Roche’s Herceptin (trastuzumab), for treating certain types of breast and gastric cancers. Herceptin had global 2017 sales of…

EMA Expects Loss of Staff in Brexit Move; Updates Continuity Plan
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The European Medicines Agency (EMA) has announced it is expecting a 30% loss in staff as it prepares to move its headquarters to Amsterdam, the Netherlands, a move it is…

Bayer to Sell Rx Dermatology Business to LEO Pharma
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Bayer has agreed to sell its global prescription dermatology unit to LEO Pharma, a Ballerup, Denmark-headquartered specialist in dermatology care. The portfolio to be acquired includes branded topical prescription treatments…

FDA Awards Research Grants in Continuous Manufacturing
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The US Food and Drug Administration (FDA) has awarded a total of $6 million to three universities to study and recommend improvements for continuous manufacturing for drug substances and drug…

Amgen Breaks Ground on US $200-Million Biomanufacturing Plant
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Amgen has broken ground for a new biomanufacturing plant that will be constructed at its West Greenwich, Rhode Island campus. The new plant, worth up to $200 million, will manufacture…

Federal Appeals Court Expedites Dr. Reddy’s Appeal Over Anti-Opioid Dependence Drug
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A federal appeals court has granted in part a motion to expedite Dr. Reddy’s Laboratories’ appeal of a preliminary injunction (PI) that was granted to Indivior, a Slough, UK-headquartered pharmaceutical…