Infectious Diseases

Revised recommendation is based on most recent data on circulating strains in US, where KP.3 is now dominant. Novavax sticks with plans targeting the JN.1 ‘parent strain.’

The company will ramp up manufacturing of its Jynneos vaccine to meet demand in worst-affected African countries and stockpiling richer nations.  

2030 sales forecasts for Novo’s obesity hope are an order of magnitude larger than its closest rival among 2025’s expected debutantes.  

Tarsus Pharmaceuticals is putting more sales and marketing heft behind its novel eyelid disease therapy, Xdemvy, to capitalize on a solid start in a previously untapped market.    

The commercial implications of the miss are hard to call, but separate trials could offer hope.    

The specialist pharma company hopes demand for mpox vaccines will help establish its vaccine platform, but cash and investor confidence remain in short supply.

The company’s VAX-31 against 31 pneumococcal serotypes outperformed Pfizer’s market-leading Prevnar 20 and could provide the broadest coverage of any vaccine in its class.

The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.

With concern over the mpox health emergency continuing to build, the Medicines Patent Pool has offered its services to play a part in the global response.

US FDA’s 2015 accelerated approval called for confirmatory trial completion by 2018, but study initiation was delayed. Completed in 2022, the trial not only verified Bexsero’s clinical benefit, it also served as the pivotal study for GSK’s pentavalent meningococcal vaccine candidate.

To help sponsors developing candidate mpox vaccines, the World Health Organization will soon be finalizing guidance on the preferred and minimum characteristics these products must satisfy regarding efficacy, dose regimen and other aspects to secure regulatory approval.

National authorities urged to address knowledge gaps and generate evidence about the dynamics of mpox transmission.

Serum Institute is working on an mpox vaccine while other Indian firms are weighing options after the WHO sounded an alert and a new case was reported in neighboring Pakistan. Scrip looks at factors that could favor development and/or manufacture of an mpox vaccine at Indian majors.

The WHO’s emergency committee has warned of a lack of understanding of the epidemiology of mpox, the limited availability of vaccines, and the complexities of donations and procurement.

The US FDA has granted marketing authorization to NOWDiagnostics for the first at-home over-the-counter test to detect syphilis, which the government says is on the rise.

The 9 September meeting on Iterum Therapeutics' oral sulopenem product for uncomplicated urinary tract infections marks the first fully in-person advisory committee drug review since the COVID-19 pandemic hit in early 2020.

The vaccines alliance says its First Response Fund could be used to cover the cost of doses and has outlined plans for a vaccine stockpile. Some experts have criticized the slow rate of response to mpox and called for more solidarity on vaccine provision at global level.

The European Medicines Agency has started reviewing new marketing applications for 10 products, including Blenrep, GSK’s previously approved multiple myeloma drug that was withdrawn from the market, and vimseltinib, which could become the EU’s first oral treatment approved for TGCT.

The Africa CDC says the donation of more than 215,000 doses of mpox vaccine is a “crucial step” in tackling the latest outbreak.

An emergency use listing means the vaccines can be approved for use in lower-income countries where they are not licensed, and will allow international organizations like Gavi and UNICEF to procure them for wider distribution.