Both the FDA and the CDC’s Advisory Committee for Immunization Practices are on the threshold of revising how vaccines are approved and used in the U.S., but whether that opens to a precipice or a new era of stronger evidence and safer use is in the telling of the beholder.
2025 has been the most challenging year in the efforts to fight HIV since at least the advent of antiretroviral therapy. In a report on “Overcoming disruption, transforming the AIDS response,” released last week ahead of World AIDS Day on Dec. 1, the Joint United Nations Program on HIV/AIDS (UNAIDS) described “a global system in shock” by sharply reduced funding from the U.S. and other wealthy nations. Scientifically, for now, progress is ongoing. To mark World AIDS Day, Nature published three independent studies on HIV.
Biopharma companies focused on infectious disease extended their stock recoveries through the third quarter (Q3), with the BioWorld Infectious Disease Index closing October up 28.98%. The gain marks a strong turnaround from earlier in the year, when the index had fallen 17.83% by the end of April before rebounding to a 4.34% gain by July’s close.
Merck & Co. Inc. is buying Cidara Therapeutics Inc. for $9.2 billion to acquire a late-stage flu candidate and also to outrace blockbuster Keytruda’s looming patent expiration. CD-388, Cidara’s lead candidate, is in a phase III study of adolescents and adults for preventing influenza A and B in those who are at a high risk of developing complications.
Phase III data from Novartis AG for the malaria treatment Ganlum (KLU-156) show it met the primary endpoint of noninferiority to the current standard of care, Coartem, a combination of artemether and lumefantrine. The results are a step to curbing a problem that has seen rising numbers in recent years.
South Korean researchers led by Lee In-suk of Yonsei University have reported the most complete oral microbiome catalog to date, with more than 72,000 genomes. Detailed in Cell Host & Microbe on Nov. 12, 2025, the database is expected to serve as a universal platform for academia and enable “precision microbiome medicine” for the industry, Lee told BioWorld.
Bluejay Therapeutics Inc.’s lead compound, the fully human monoclonal antibody brelovitug (BJT-778), produced positive virologic response data in the company’s phase II study of chronic hepatitis D virus, a condition with no approved treatment in the U.S.
Industry watchers were surprised when Eli Lilly and Co.’s oral GLP-1 candidate, orforglipron, did not appear among the first nine recipients of the U.S. FDA’s commissioner’s national priority voucher (CNPV) program aimed at shortening regulatory review times, boosting domestic manufacturing and improving affordability. But orforglipron, which recently nailed endpoints in a second phase III trial and has been hailed a potentially best-in-class compound, was among the second batch of six drugs added to the CNPV list.
Ena Respiratory Pty Ltd. raised an AU$34 million (US$22.4 million) series B round to advance INNA-051, its nasal spray for symptomatic viral respiratory infections, to phase II trials. New investors in the Melbourne-headquartered company include the Gates Foundation and Flu Lab. Existing investors Brandon Capital, Uniseed and Stoic Venture Capital also participated in the round.
Moderna Inc. stopped its efforts to develop mRNA-1647 as a vaccine for preventing congenital cytomegalovirus infection, the most common infectious cause of birth defects in the U.S. The pivotal and placebo-controlled phase III CMVictory study of mRNA-1647 missed the primary efficacy endpoint, which was preventing the infection in seronegative females ages 16 to 40.
RSS
