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, December 28, 2017
Fervent Pharmaceuticals has submitted an IND application to the FDA for FP-101.
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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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Wednesday, January 03, 2018
Cantex announced the FDA has granted Orphan Drug Designation to CX-01 for the treatment of acute myeloid leukemia.
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Wednesday, January 03, 2018
The FDA has notified Palatin that it may proceed with its clinical investigation of subcutaneous injection PL-8177.
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Thursday, January 04, 2018
Janssen Research & Development
Beacon Discovery has entered into a collaboration agreement with Janssen Pharmaceuticals.
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Spruce Biosciences announced the EMA has granted orphan drug designation for SPR001 for the treatment of congenital adrenal hyperplasia.
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Datavant and Verge Genomics announced a strategic alliance to unlock the value of pharmaceutical datasets to accelerate drug discovery and development...
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Ionis Pharmaceuticals announced its New Drug Application for inotersen has been accepted for Priority Review by the FDA.
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MEI Pharma announced the FDA has cleared the company's IND for voruciclib, an orally available CDK9 inhibitor, for patients with relapsed/refractory B...
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Tuesday, January 09, 2018
Eisai and Merck have received Breakthrough Therapy Designation from the FDA for LENVIMA in combination with KEYTRUDA for renal cell carcinoma.
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Wednesday, January 10, 2018
As part of the collaboration, the two companies will evaluate the combination of Syndax's entinostat and Genentech's atezolizumab, in patients with ...
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Thursday, January 11, 2018
Forty Seven announced an agreement with Merck KGaA, Darmstadt, Germany to conduct a Phase 1b clinical trial combining Hu5F9-G4 with avelumab in ...
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Ortho Dermatologics announced FDA has accepted the New Drug Application for IDP-121 (tretinoin 0.05%) lotion (ALTRENO).
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Wednesday, January 17, 2018
Relmada has acquired the global rights to develop and market dextromethadone, a NMDA receptor antagonist.
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Wednesday, January 17, 2018
Outpost Medicine announced the FDA has accepted two IND applications for its lead product candidate, OP-687.
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