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.
Tuesday, December 19, 2017
In recent years, the medical community has experienced a shift in the way health care is practiced.
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Tuesday, December 19, 2017
Second Genome has successfully completed a Phase 1 study in healthy volunteers for its lead therapeutic candidate, SGM-1019.
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Friday, December 22, 2017
Santen Pharmaceutical (Japan) and Santen (USA) announced the FDA has issued a complete response letter for the NDA for intravitreal sirolimus.
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Wednesday, December 27, 2017
BioMarin announced the FDA will require additional time to complete its review of the BLA for its investigational therapy pegvaliase.
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Wednesday, December 27, 2017
Beckman Coulter Diagnostics announced FDA clearance of its automated Access AMH immunoassay for in vitro diagnostic (IVD) use.
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Friday, December 29, 2017
Twice a year the federal government publishes the Unified Agenda which provides the American public with insight into regulations under development or...
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Tuesday, January 09, 2018
Agilent Technologies has acquired Cork, Ireland-based Luxcel Biosciences, a developer of real-time fluorescence plate-reader based in vitro cell assay...
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Wednesday, January 10, 2018
The FDA has agreed to allow Mayo Clinic to use an automated bioreactor-based stem cell production platform on its campus in Jacksonville, Florida.
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Thursday, January 11, 2018
Helsinn and MEI Pharma announced the EMA has granted Orphan Drug Designation to pracinostat in a Phase 3 study in combination with azacitidine for the...
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Tuesday, January 23, 2018
The National Institutes of Health will launch an effort aimed at removing barriers that slow the adoption of genome editing for treating patients.
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Friday, February 23, 2018
Kite and Sangamo announced the companies have entered into a worldwide collaboration using Sangamo’s ZFN technology platform for the development of ...
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Soligenix announced the European Commission has granted orphan drug designation to the company's recombinant modified ricin toxin A-chain subunit for ...
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Mirata BioPharma announced it is now a Resident Company at Johnson & Johnson Innovation, JLABS at Texas Medical Center located in Houston, TX.
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Based on the FDA’s guidance, Kadmon plans to initiate an open-label, two-arm, pivotal Phase 2 clinical trial to support the potential registration of ...
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The FDA approved Epidiolex (cannabidiol) oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy in patients...
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