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.
Catalent, Inc., the leading global provider of development sciences and manufacturing platforms for medicines, including biotherapeutics; cell and ...
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Octapharma USA announced the FDA Office of Orphan Products Development (OOPD) has awarded seven years of marketing exclusivity for Octagam® 10% [...
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Wednesday, September 01, 2021
Merck announced a label update for KEYTRUDA Merck’s anti-PD-1 therapy, for its indication in first-line advanced urothelial carcinoma (bladder cancer)...
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Wednesday, September 01, 2021
The Janssen Pharmaceutical Companies of Johnson & Johnson announced the FDA has approved long-acting atypical antipsychotic INVEGA HAFYERA™ (6-month ...
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Thursday, September 02, 2021
Astellas Pharma Inc announced that it has voluntarily paused screening and dosing of additional participants in its ASPIRO clinical trial evaluating ...
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Thursday, September 02, 2021
FDA Requires Warnings About Increased Risk of Serious Heart-Related Events, Cancer, Blood Clots, and Death for JAK Inhibitors That Treat Certain ...
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Friday, September 03, 2021
BeiGene Ltd, a global biotechnology company focused on developing and commercializing innovative medicines worldwide, announced that BRUKINSA® (...
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Friday, September 03, 2021
Takeda Pharmaceutical Company Limited announced that the Phase 3 PANTHER (Pevonedistat-3001) study did not achieve pre-defined statistical ...
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Friday, September 03, 2021
Impel NeuroPharma Inc., a commercial-stage biopharmaceutical company developing transformative therapies for people suffering from diseases with high ...
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Friday, September 03, 2021
The FDA has approved Invega Hafyera (paliperidone palmitate) extended-release injectable suspension to treat schizophrenia in certain adults. Invega ...
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Tuesday, September 07, 2021
The FDA introduced a new pathway for manufacturers to obtain FDA review of certain novel excipients (inactive ingredients) prior to their use in drug ...
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Tuesday, September 07, 2021
Merck’s anti-PD-1 therapy was approved by the National Medical Products Administration (NMPA) in China in combination with platinum- and ...
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Wednesday, September 08, 2021
The FDA revised the guidance for industry Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers, ...
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Thursday, September 09, 2021
Soligenix, a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet ...
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Monday, September 13, 2021
BeiGene, a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and ...
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