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Antibiotic Market Snapshot: In Exchange For Higher Prices, More Value

 
• By Jessica Merrill

Drug developers face enormous regulatory and commercial hurdles in the antibiotics market, but industry is looking to challenge the current business model with new premium-priced drugs that deliver compelling pharmaco-economic benefits over generics.

The antibiotic market hasn’t enticed many drug makers.Research in the space has always been spotty but it ground to a halt five years ago in the wake of the safety scandal involving Sanofi-Aventis’ Ketek (telithromycin): deaths and liver-related adverse events stemming from an approval based on fraudulent trial data. Some big pharmas like Pfizer Inc. and Johnson & Johnson abandoned discovery research in the space or significantly reduced R&D investment, as industry turned its focus to more profitable therapeutic areas with less regulatory risk, like oncology and inflammatory disease.

But demand for new antibiotics that target resistant bacteria has only grown, and a handful of start-ups and a few mid-to-large pharma still believe in the commercial potential

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More from Clinical Trials

What The EMA Can Teach HTA Bodies About Joint Clinical Assessments

 
• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
• By Eliza Slawther

Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up

 
• By Vibha Sharma

The policy expectation that the model clinical trial agreements are used without modification is in line requests from industry and the NHS/HSC.

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

More from R&D

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

Aragen’s CEO Says NIH Funding Cut Means Less R&D Money, And Tariffs Would Add To Woes

 
• By Vibha Ravi

Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an interview.

‘Come Early, Come Often,’ EMA Chief Tells Industry

 
• By Francesca Bruce

The European Medicines Agency’s chief, Emer Cooke, explained how the agency could help companies with their drug development plans, and said the EU Health Technology Assessment Regulation would help companies design clinical trials that are fit for regulators and HTA bodies.