Posts tagged European Medicines Agency
NeuroproteXeon additional Phase 2 data published in JACC

Closely-held NeuroproteXeon announced the publication of a second finding from a randomized, controlled Phase 2 trial of inhaled xenon and oxygen, combined with hypothermia, for out-of-hospital cardiac arrest (OHCA) patients.

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Molteni to commercialize Titan Pharma’s Probuphine in Europe

Titan Pharmaceuticals (NASDAQ:TTNP) has entered into a binding term sheet with L. Molteni & C. dei F.lli Alitti Società di Esercizio S.p.A. of Italy, giving Molteni an exclusive license to commercialize Probuphine in the European Union, including the UK and Northern Ireland, Switzerland, Norway, Iceland, Liechtenstein, Bosnia, Serbia, Montenegro, Macedonia and Albania.

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Dipexium gets SME designation in Europe

Dipexium Pharmaceuticals (NASDAQ:DPRX) has been granted small and medium enterprise (SME) designation by the European Medicines Agency (EMA). 

The company recently completed its pivotal Phase 3 clinical trials - OneStep-1 and OneStep-2 - with its topical antimicrobial peptide, Locilex, in mild infections of diabetic foot ulcers in the U.S. under a special protocol assessment agreement from FDA. 

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Maxim cuts Omeros price target to $19

Maxim Group lowered its price target for Omeros (NASDAQ:OMER) to $19 from $30, citing a higher risk value from its three valuation models. The stock closed at $13.38 on Tuesday.

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Dipexium completes enrollment in second Phase 3 trial

Dipexium Pharmaceuticals (NASDAQ:DPRX) has completed patient enrollmentin the OneStep-1 pivotal Phase 3 clinical trial of its Locilex broad-spectrum, topical antibiotic peptide.

Last week, the company reached the enrollment objective in the OneStep-2 pivotal trial.

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Dipexium completes enrollment in one Locilex Phase 3 trial

Dipexium Pharmaceuticals (NASDAQ:DPRX) has completed the patient enrollment objective in the OneStep-2 Phase 3 clinical trial of its Locilex topical antibiotic peptide.

The company’s OneStep-1 Phase 3 clinical trial has passed the 98% enrollment mark and is expected to reach the 180-patient enrollment objective soon.

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Can-Fite submits Phase 3 RA trial protocol to EMA

Can-Fite BioPharma (NYSE MKT:CANF; TASE:CFBI) has submitted to the European Medicines Agency (EMA) a protocol design for a Phase 3 trial and registration plan for its lead compound, CF101, in the treatment of rheumatoid arthritis. The company previously had a pre-submission meeting with the EMA.

The global trial is expected to begin in either the second or third quarter of 2016. It will investigate the efficacy and safety of CF101 administered orally twice daily for 16 weeks to patients with active rheumatoid arthritis treated with conventional disease modifying drugs.

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Dipexium reaches 75% enrolment in Phase 3 trials

Dipexium Pharmaceuticals’ (NASDAQ:DPRX) OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials have reached the 75% enrollment milestone in total, with each study having enrolled nearly the same number of patients.

OneStep-1 and OneStep-2 are identical Phase 3 trials, with 180 patients per clinical trial. They are being conducted under a SPA with the FDA for evaluation of Locilex for the treatment of patients with mild infections of diabetic foot ulcers.

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Can-Fite unveils clinical milestones for 2016

Can-Fite BioPharma (NYSE MKT:CANF; TASE:CFBI) has announced its anticipated clinical milestones for 2016.

“We are very encouraged by the clinical and preclinical data from each of our drugs to date, which indicate their efficacy across six major indications,” CEO, Dr. Pnina Fishman, said in a statement.

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