The latest news from the global pharmaceutical industry. Below you will find news and information to keep you up-to-date with what is happening in your industry. Coverage includes regulatory approvals, recall announcements, mergers and acquisitions, personnel news and appointments, new facility and facility expansion updates, collaborations and agreements, and financial updates.
Thursday, January 27, 2022
Merck announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the adjuvant treatment of adults ...
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Thursday, January 27, 2022
This week, FDA published a series of guidances focused on generic drug application submissions, labeling, and review. These guidances are part of our ...
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Wednesday, January 26, 2022
In light of the most recent information and data available, the FDA revised the authorizations for two monoclonal antibody treatments – bamlanivimab ...
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Wednesday, January 26, 2022
Immunocore Holdings announced the approval from the United States Food and Drug Administration (FDA) of KIMMTRAK® (tebentafusp-tebn) for the treatment...
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Tuesday, January 25, 2022
Merck announced that the FDA has issued a Complete Response Letter (CRL) regarding the NDA for gefapixant, the investigational, non-narcotic, orally ...
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Karyopharm Therapeutics Inc. announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for eltanexor, a novel ...
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Lantern Pharma announced that the U.S. Food and Drug Administration (FDA) has granted both Rare Pediatric Disease Designation and Orphan Drug ...
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FDA-TRACK is releasing the latest annual User Fee Program data for animal and human drug and biosimilar products. Final review performance results for...
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Wednesday, January 19, 2022
Endo International announced that it and its wholly-owned subsidiaries Endo Pharmaceuticals Inc. and Endo Health Solutions Inc. have entered into a ...
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Wednesday, January 19, 2022
Merck and Ridgeback Biotherapeutics announced the signing of a long-term supply agreement with the United Nations Children’s Fund (UNICEF) to ...
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Wednesday, January 19, 2022
Regeneron Pharmaceuticals, Inc. announced the FDA acceptance to review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor ...
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Tuesday, January 18, 2022
Protagen Protein Services GmbH, BioAnalytix, Inc., and GeneWerk GmbH announced their unified operations and re-brand as ProtaGene, a CRO partner for ...
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Thursday, January 13, 2022
AstraZeneca has signed a collaboration agreement with Scorpion Therapeutics to discover, develop and commercialize precision medicines against ...
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Thursday, January 13, 2022
Adare Pharma Solutions, a global, technology-driven contract development and manufacturing organization (CDMO), announced the appointment of Tom ...
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Absci Corporation has entered into a research collaboration with Merck (known as MSD outside the United States and Canada), using Absci’s AI-powered ...
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