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Tag: specialty pharmaceutical company

Are You Aware of the FDA's Plans for 2018?

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Knight Therapeutics and SIFI Announce Filing of New Drug Submission

Knight Therapeutics (TSX:GUD) a leading Canadian specialty pharmaceutical company, and S.I.F.I- Società Industria Farmaceutica Italiana S.p.A., a prominent Italian Eye Care company, today announced that Knight’s New Drug Submission for NETILDEX™ has been accepted for review by Health Canada. NETILDEX™ is a fixed combination of netilmicin and dexamethasone for the

Evoke Announces Discovery of Sex-Based Pharmacokinetic Differences for Gimoti

Evoke Pharma (NASDAQ:EVOK), a specialty pharmaceutical company focused on treatments for gastrointestinal (GI) d­­iseases, today announced additional findings from its comparative exposure pharmacokinetic (PK) trial for Gimoti™, the Company’s novel nasal spray delivery of metoclopramide for the treatment of symptoms associated with gastroparesis. Further analysis of the PK data by sex

Opiant Pharmaceuticals Announces Development of OPNT003

Opiant Pharmaceuticals (NASDAQ:OPNT), a specialty pharmaceutical company developing pharmacological treatments for addictions, today announced positive data from a Phase I clinical study of its product candidate OPNT003 and provided an update on a meeting held February 8, 2018 with the U.S. Food and Drug Administration (FDA) regarding its planned development

Elite Pharmaceuticals and SunGen Pharma File ANDA

Elite Pharmaceuticals (OTCBB:ELTP) a specialty pharmaceutical company developing abuse-deterrent opioids and niche generic products, today announced that it has filed an Abbreviated New Drug Application with the US Food and Drug Administration (FDA) for a generic version of an immediate release CNS stimulant.

As quoted in the press release:
“The filing of

Aequus and Camargo Prepare for Meeting with FDA to Advance Anti-Nausea Patch

Aequus Pharmaceuticals (TSXV: AQS) a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, today announced plans to advance its transdermal patch for pregnancy-related anti-nausea, AQS1303, following positive results from the proof of concept study completed in 2017.

As quoted in the press release:
“We feel very strongly about the

Aequus Announces Change to Proposed $300,000 Equity Financing

Aequus Pharmaceuticals (TSXV:AQS) a specialty pharmaceutical company with a focus on developing, advancing and promoting differentiated products, is pleased to announce that, further to its news release dated January 11, 2018 announcing a proposed $300,000 equity financing, it now intends to complete the equity financing of 1,000,000 units of the

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