Anti-infective
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.
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.