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Plazomicin’s US Debut Pencilled In For 2018, Achaogen Now Searching For Ex-US Partner

 
• By John Davis

Top-line results from the pivotal Phase III EPIC study, and the smaller CARE study in patients with serious infections due to carbapenem-resistant Enterobacteriaceae (CRE) pathogens, should allow Achaogen to find an ex-US marketing partner and submit a US marketing application in 2017 for its potential new antibacterial, plazomicin, that could address a growing market opportunity in multidrug resistant infections.

South San Francisco biotech Achaogen Inc.has announced top-line Phase III results with its lead product, plazomicin, an engineered aminoglycoside, that it says puts it in a position potentially to offer a much needed new treatment option for serious multidrug-resistant bacterial infections.

The company believes plazomicin is unique in the way it has been engineered to make it resistant to aminoglycoside-modifying enzymes...

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Kailera Eyes Global Obesity Market With Hengrui’s Phase III Dual Agonist

 
• By Joseph Haas

With China’s Hengrui reporting successful Phase III data for its dual GLP-1/GIP agonist, licensee Kailera is readying plans to demonstrate better efficacy than current obesity drugs.

Sellas Targets Tambiciclib To Adverse-Risk Frontline AML Patients After Phase II Success

 
• By Alaric DeArment

The biotech announced positive Phase II data for the drug combined with AbbVie/Roche’s Venclexta and BMS’s Vidaza in relapsed/refractory acute myeloid leukemia.

China’s Mid-Cap Companies Thriving On Big Pharma Deals

 
• By Andrew McConaghie and Edwin Elmhirst

Big pharma is increasingly looking east to restock its pipelines, a process that is helping to forge a new generation of mid-sized R&D-based companies in China and is reflected in their stock price performance.

In Brief: Nanoscope Ploughs Forward With FDA Application For Retinitis Pigmentosa Gene Therapy

 
• By Manas Mishra

Nanoscope’s experimental gene therapy, MCO-010, is designed to target the broader retinitis pigmentosa population, regardless of the underlying gene mutation, with a completed US regulatory submission expected in early 2026.

More from Scrip

In Brief: Nanoscope Ploughs Forward With FDA Application For Retinitis Pigmentosa Gene Therapy

 
• By Manas Mishra

Nanoscope’s experimental gene therapy, MCO-010, is designed to target the broader retinitis pigmentosa population, regardless of the underlying gene mutation, with a completed US regulatory submission expected in early 2026.

Stock Watch: Pharma Financial Forecasts Cannot Withstand Headwinds Forever

 
• By Andy Smith

Pharma company financial guidance emerged largely unscathed from a first quarter punctured by a weakening US dollar and threats of import tariffs on drugs. With other pressures either already evident or on the horizon, guidance revisions may be unavoidable.

Q2 Korea Biotech Roundup: Licensing Deals End, Trials Progress, IPOs Recover

 
• By Jung Won Shin

Aside from several sizable global out-licensing deals, South Korean bioventures saw a cancellation of other alliances, updated their pipelines with losses and gains and reported clinical trial progress in the second quarter, while domestic IPO sentiment also improved.