Anti-infective
The US FDA approved Blujepa for the treatment of uncomplicated urinary tract infections, marking the first new mechanism of action for the infection in more than 30 years.
Professor Anil Koul shares vignettes of his life and career trajectory, a captivating mix of hope, science and destiny that took him to the lab of eminent cancer biologist Alex Ullrich at the Max Planck Institute and also saw him contribute to the development of breakthrough TB drug bedaquiline. He also talks about Medicine 3.0 and the intersection of science and spirituality.
The company is developing doravirine and islatravir together as an alternative to therapies containing integrase inhibitors, like Biktarvy, especially as HIV patients age.
The two companies were among those presenting data at CROI that highlighted the next frontiers of competition in the HIV space.
CSL’s US influenza vaccine sales were a window into wider issues for vaccine manufacturers that had already impacted the fourth-quarter results of Merck, Pfizer and GSK. There could also be a correlation between lower vaccine sales and the measles outbreak in Texas.
The vaccine maker also reacted to news of the FDA’s annual flu vaccine meeting being canceled and the postponement of the CDC’s ACIP meeting.
Over 140 biopharma leaders share their views on developments to watch for in key therapeutic areas this year. Advances in multiple scientific fields are opening up new avenues for treatment.
The FDA approved Vimkunya on 14 February as the first vaccine for preventing chikungunya in adolescents as well as adults.
Kostaive is the first self-amplifying mRNA COVID-19 vaccine to receive approval from the European Commission and could provide serious competition to Pfizer/BioNTech's Comirnaty and Moderna's Spikevax.
Pfizer has been unable to take a big slice of the meningococcal vaccine market with Penbraya and now GSK looks set to consolidate its lead with its new 5-in-1 vaccine.
Scrip surveys some of the more interesting Phase III clinical trial readouts expected this year.
The drug maker withdrew its goal of $11bn in sales for the HPV vaccine and paused shipments to China so that partner Zhifei can reduce its inventory.
As rival Bavarian Nordic closes in on US approval for its chikungunya vaccine for people aged 12 and older, the French biotech has presented positive data for its already-approved jab Ixchiq in adolescents and children.
The Swiss firm’s plans to go public are a boost for the antibiotics space and for hopes that the continent’s biotechs may follow their US counterparts and find financial solutions on the capital markets.
A week after a downbeat forecast at J.P. Morgan Healthcare Conference, the US mRNA specialist has pocketed another sizeable sum from the US Department of Health and Human Services to accelerate development of an H5N1 mRNA pandemic influenza vaccine.
At J.P. Morgan, GSK, Sanofi and Pfizer said they are prepared to address questions about vaccines under a new US administration, while former FDA commissioner Gottlieb warned of threats to public safety.
Former Roche CEO Bill Burns reflects on transforming Roche into a global leader in specialty care and oncology. Now, as he spearheads efforts to combat antibiotic resistance, Burns shares insights on industry evolution, the power of cultural change, and the urgent need for a new business model in antibiotics development.
Recent data put Vir and Bluejay ahead of the pack, but it is hard to know exactly how well their products work.
The drug maker said in its third quarter earnings report that competition from other therapeutic classes, particularly bispecifics, resulted in a slight decline of sales for the CAR-T.
The US FDA approved Orlynvah for uncomplicated urinary tract infections among adult women, despite some concerns about the potential for off-label use and resistance.