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.
Windtree Therapeutics has dosed the first patient in its Phase 2 study of istaroxime in patients experiencing early cardiogenic shock.
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Aegle announced the FDA has granted Fast Track designation to AGLE-102 for dystrophic epidermolysis bullosa.
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Ovid announced results from the ARCADE and ENDYMION studies of soticlestat in patients with developmental and epileptic encephalopathies.
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Janssen Research & Development
Janssen announced the FDA has approved SIMPONI ARIA for patients 2 years of age and older for the treatment of active pJIA and has extended the PsA ...
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Wednesday, September 30, 2020
JanOne has started production of JAN101 under cGMP for the company's anticipated Phase 2b trials to treat PAD and as a potential treatment for Covid-...
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Wednesday, September 30, 2020
Cipla has received final approval for its ANDA for Dimethyl Fumarate DR Capsules from the FDA.
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Wednesday, September 30, 2020
CSL Behring announced the FDA has approved an expanded indication for HAEGARDA for routine prophylaxis to prevent HAE attacks in patients 6 years of ...
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Wednesday, September 30, 2020
Shionogi announced the FDA has approved a sNDA for FETROJA for HABP/VABP caused by Gram-negative microorganisms.
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Wednesday, September 30, 2020
Enesi Pharma has reported positive top-line results from a study evaluating the immune responses generated by an ImplaVax-enabled unit solid-dose ...
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Tuesday, September 29, 2020
The FDA issued an EUA for the first serology POC test for COVID-19.
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Tuesday, September 29, 2020
The FDA has approved Nucala for adults and children aged 12 years and older with HES for six months or longer without another identifiable non-blood ...
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Tuesday, September 29, 2020
Eiger announced results of an investigator sponsored study of Peginterferon Lambda-1a in outpatients with mild and uncomplicated COVID-19.
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Monday, September 28, 2020
ENTEROME announced the first patient has been dosed in a trial of sibofimloc in patients with Crohn's disease.
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Monday, September 28, 2020
DURECT has dosed the first patient in its randomized, double-blind, placebo-controlled, multi-center Phase 2 study to evaluate the safety and efficacy...
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Friday, September 25, 2020
Vaccinex announced topline results from the early manifest treatment arm of the Phase 2 double-blind, placebo-controlled SIGNAL trial of its lead ...
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