Latest news with #gepotidacin
Yahoo
a day ago
- Business
- Yahoo
GSK climbs after winning FDA priority review for oral gonorrhoea antibiotic
-- GSK (NYSE:GSK) (LON:GSK) said on Monday that the U.S. Food and Drug Administration has accepted its priority review application for gepotidacin, an oral antibiotic aimed at treating sexually transmitted uncomplicated gonorrhoea. The drugmaker's shares climbed 1% in London on the news. The company is looking to new infectious disease products, including its recently launched respiratory syncytial virus vaccine, to offset expected revenue declines from top-selling medicines and looming patent expirations in its HIV portfolio. Gepotidacin is already approved in the U.S. under the brand name Blujepa for treating a common urinary tract infection in women and adolescent girls. The FDA is expected to decide in December on its use for uncomplicated urogenital gonorrhoea, which could offer patients an oral alternative to existing injectable treatments. Separately, GSK and Germany's CureVac last week resolved a long-running patent dispute with Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX) over mRNA vaccine technology used during the COVID-19 pandemic. The settlement follows BioNTech's June agreement to acquire CureVac in an all-stock deal worth $1.25 billion to advance work on mRNA-based cancer therapies. Under the settlement, CureVac and GSK will receive $740 million and single-digit percentage royalties on future U.S. sales of COVID-19 vaccines, CureVac said. GSK's share amounts to $370 million, including $50 million to adjust terms from a 2024 licence agreement that expanded their pandemic-era partnership. If BioNTech's takeover of CureVac is completed, related mRNA litigation outside the U.S. will also be resolved, with GSK receiving an additional $130 million and royalties extended to non-U.S. sales. CureVac said the acquisition remains on track under the agreed terms. GSK said it still has separate patent cases against Pfizer and BioNTech in the U.S. and Europe, which are unaffected by this settlement. Related articles GSK climbs after winning FDA priority review for oral gonorrhoea antibiotic USPS blocks major vape distributor over unregulated product shipments - Reuters Exclusive: Opendoor CEO Wheeler breaks silence, EMJ's Eric Jackson calls for more Sign in to access your portfolio
Reuters
a day ago
- Health
- Reuters
GSK's antibiotic gets FDA priority review for oral treatment of gonorrhoea
Aug 11 (Reuters) - British drugmaker GSK said on Monday that the U.S. Food and Drug Administration has accepted its application for priority review of gepotidacin, an oral antibiotic to treat sexually transmitted uncomplicated gonorrhoea. GSK is counting on new infectious disease treatments, such as its recently launched respiratory syncytial virus vaccine, to help offset revenue losses from its top-selling drugs and anticipated patent expirations for its HIV therapies. The drug gepotidacin has already been approved in the United States under the brand name Blujepa for a common type of urinary tract infection (UTI) in women and adolescent girls. The FDA's decision on the drug's treatment of uncomplicated urogenital gonorrhoea is expected in December. If approved, it would provide an oral option to patients who currently rely on injectable treatments.
