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, October 20, 2020
RedHill announced that the FDA has granted Orphan Drug Designation to RHB-204 for nontuberculous mycobacteria disease.
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Enlivex reported that the Israeli Ministry of Health authorized the initiation of a proposed investigator-initiated Phase II clinical trial evaluating...
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Cyclerion Therapeutics announced results from its Phase 1 translational pharmacology study of IW-6463, the first soluble guanylate cyclase (sGC) ...
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Harmony Biosciences announced the FDA has approved WAKIX for cataplexy in adult patients with narcolepsy.
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Relief and NeuroRx has announced topline results from an open-label prospective study where 21 patients admitted to an ICU with critical COVID-19 and ...
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Linnaeus has dosed the first patient in its trial of its lead-product-candidate, LNS8801, in combination with KEYTRUDA in patients who had previous ...
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BioGX announced FDA EUA submission of an extraction-free, direct sample addition RT-PCR test for detection of SARS-CoV-2 viral RNA in patients ...
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Thursday, October 15, 2020
Avenue Therapeutics has received a Complete Response Letter CRL from the FDA regarding the Company’s NDA for IV tramadol.
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Thursday, October 15, 2020
Astellas and Seagen announced positive topline results from the second cohort of patients in the pivotal phase 2 single-arm clinical trial known as EV...
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Thursday, October 15, 2020
BioGX announced EUA submission of an extraction-free, direct sample addition RT-PCR test for detection of SARS-CoV-2 viral RNA in patients suspected ...
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Wednesday, October 14, 2020
Since the beginning of the COVID-19 pandemic, Lilly has brought the full force of our scientific capabilities to fight this new disease, collaborating...
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Wednesday, October 14, 2020
Ascentage announced the FDA has granted two Orphan Drug Designations (ODDs) to two of the company's apoptosis-targeting assets.
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Wednesday, October 14, 2020
Rigel announced enrollment of the first patients in a multicenter, Phase 2 trial to evaluate the safety of fostamatinib.
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Wednesday, October 14, 2020
Alkermes announced positive voting outcomes from the joint meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk ...
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Tuesday, October 13, 2020
J&J has temporarily paused further dosing in all COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an ...
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