Anti-infective
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.
Pfizer beat GSK with a new indication for its RSV vaccine in high-risk individuals aged 18-59.
Gilead presented 48-week data for the combination of weekly oral lenacapavir/islatravir, showing results consistent with 24-week data. A Phase III program will soon begin.
Full data from Merck & Co’s Phase IIb/III trial of its novel RSV antibody suggest that it will have to fight hard against Sanofi/AstraZeneca’s leader.
There have been no new class of oral antibiotics for uncomplicated urinary tract infections approved for over two decades. With a priority review secured in the US, GSK's triazaacenaphthylene offering could make it to market by March next year.
Arexvy has become the first RSV vaccine to show it can provide protection over three years – but that might mean lower market uptake than originally expected.
One of Enanta’s two antivirals in development for RSV showed efficacy in a healthy patient challenge trial. But analysts say field studies of infected patients are more telling.
Deal Snapshot: Merck likes the look of Evaxion's artificial intelligence-based technology platform to develop immunotherapies and signed a biobucks deal that will help ease the Copenhagen-headquartered biotech's financial situation.
The company said the CENTERSTONE study marked the first time a global Phase III trial showed reduced transmission of influenza.
The company stands a strong chance of winning approval for lenacapavir as a twice-yearly injectable drug for preventing HIV infection, though market challenges remain.
Its vaccine candidate will now proceed to Phase III, but might be hard pressed to compete against Moderna’s flu plus COVID-19 combination shot.
Failure of GSK’s targeted immunotherapy leaves field open for Moderna and BioNTech candidates.
The cash-strapped Danish biotech has got some positive news flow on its vaccines for gonorrhea and melanoma and believes that Phase II data on the latter in particular will attract attention at the major oncology conference kicking off in Barcelona this week.