Wave Life Sciences Ltd. has reported that GSK plc has selected its first two programs to advance to development candidates following achievement of target validation as part of the companies’ ongoing collaboration.
With two respiratory syncytial virus (RSV) vaccines approved by the U.S. FDA in 2023 and a third nearing its May PDUFA date, decades of research has finally provided infants and older adults protection from the disruptive and sometimes deadly virus. But what about people in the middle, particularly those with certain chronic medical conditions? New York-based Pfizer Inc. rolled out phase III data April 9 showing that its approved RSV vaccine, Abrysvo (RSVpreF), met primary endpoints in adults ages 18 to 59 who were at high risk of RSV.
After a complete response letter (CRL) from the U.S. FDA in 2022 and approvals in Europe, Japan and Australia, Akebia Therapeutics Inc.’s Vafseo (vadadustat) has finally been approved by the FDA. But the uphill climb still isn’t over for Akebia, as it has more hurdles to clear for the drug.
At this week’s ACS meeting in New Orleans, Fimbrion Therapeutics Inc. presented the rational design of a different series of small-molecule biaryl O- and C-linked mannoside-based inhibitors of the virulence factor FimH, as potential agents for the treatment of urinary tract infections (UTIs).
With a regulatory filing expected later this year for gepotidacin based on positive data in uncomplicated urinary tract infections, GSK plc reported that the potentially first-in-class oral antibiotic hit its endpoints in a phase III trial in uncomplicated urogenital gonorrhea, the sexually transmitted disease facing a rise in incidence rate and increased antibiotic resistance.
After more than a decade of industry pleading for guidance on Orange Book patent listings, the U.S. FDA is finally planning on answering that request this year. If the guidance that’s produced reflects the FTC’s position that device patents can’t be listed for combination products, it could overturn years of accepted practice and possibly hinder the development of new, more advanced drug administration technologies.
GSK plc has exercised its option to a nonexclusive license to Elsie Biotechnologies Inc.’s discovery platform, following a successful research collaboration both companies entered into last year to explore platform capabilities.
Merck & Co. Inc. CEO Robert Davis said the pneumococcal vaccines (PCVs) space is “an area where there is still a high unmet need, and what we have is a new vaccine specifically targeted to the adult population that addresses 83% of the residual disease. That's about 30% higher than anyone else that's out there.” Speaking Jan. 9 at the J.P. Morgan Healthcare Conference (JPM), Davis predicted that his firm “will take a majority share” of the market if approved. The Merck candidate, V-116, bears a PDUFA date with the U.S. FDA of June 17.
When life-saving inhalers sell in Europe at 1.5% to about 8% of their list price in the U.S., they’re bound to attract scrutiny, especially in a time when inequities in prescription drug prices are fueling more and more legislation to reduce U.S. prices.
GSK plc is plunking down $1 billion cash to take over Aiolos Bio Inc., with the promise of as much as $400 million in regulatory milestone payments along with tiered royalties. The deal gives London-based GSK asthma candidate AIO-001, a phase II-ready, long-acting antibody that binds to the human thymic stromal lymphopoietin (TSLP) ligand to inhibit TSLP signaling and relieve inflammation. GSK said AIO-001 could redefine the standard of care in asthma via the prospect of dosing every six months.
