Takeda Pharmaceutical Co. Ltd. has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be addressed within the current BLA review cycle,” the company said in a statement.
Sanofi SA and Astrazeneca plc had a lot to celebrate July 17 when the FDA approved Beyfortus (nirsevimab) ahead of schedule, making it the first respiratory syncytial virus (RSV) prophylactic for infants in the U.S. “This is just really an historic day,” Michael Greenberg, a Sanofi vice president and medical head of the company’s North America vaccines unit, told BioWorld. The companies had been expecting the FDA decision later this quarter. The earlier approval suggests the FDA appreciated the urgency of having time for health systems and doctors to get the drug ahead of the next RSV season, Greenberg said.
Research at Pharmablock Sciences (Nanjing) Inc. has led to the development of spirooxindole compounds acting as 3C-like proteinase (3CLpro; Mpro; nsp5) (SARS-CoV-2; COVID-19 virus) inhibitors and thus reported to be useful for the treatment of viral infections.
Viiv Healthcare Group’s long-acting therapies to treat human immunodeficiency virus (HIV), including cabotegravir as an oral tablet and as an injectable, have been approved by China’s NMPA, expanding the company’s presence in the sector and giving HIV patients in the country a new treatment option.
A chance discovery has led to a new class of antibiotics with multiple arms that interacted with the cell wall of gram-positive bacteria, inhibiting their assembly and disarming them. “It was an accidental discovery. We were using it to stain cells. We also were running evaluations of antibiotics. One of my former students came to me and said: ‘I think we have discovered something that is quite potent as an antibiotic,’” the senior author Xingyu Jiang told BioWorld.
The counterintuitive side of preventing a health crisis prompted by antimicrobial resistance showed itself at a July 11 U.S. Senate hearing, with witnesses saying that antibiotics exist to treat current infections but they often don’t have staying power in the market.
Takeda Pharmaceutical Co. Ltd. has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be addressed within the current BLA review cycle,” the company said in a statement. News of the withdrawal comes more than a month after the May 23 Qdenga PDUFA date. The future plan for Qdenga in the U.S. will be further evaluated given the need for travelers and those living in dengue-endemic areas of the U.S., such as Puerto Rico.
Moderna Inc. may have risen to prominence during the pandemic with its messenger RNA (mRNA)-based COVID-19 vaccine, but it’s now casting a net far larger and wider. The company said on July 5 that it is readying international approval for its second mRNA vaccine called mRNA-1345 for respiratory syncytial virus (RSV)-associated acute respiratory disease based on positive interim data from the ongoing Conquer RSV study in individuals 60 and older.
RSS
