Intellectual frustration mounted at this morning’s meeting of the CDC’s Advisory Committee for Immunization Practices when panelist Cody Meissner tried to refute the presentations given on the burden of the hepatitis B virus (HBV), the safety of HBV vaccines and the policy context. “I take strong positions against each of the three presentations that have been made,” Cody Meissner, a pediatric infectious disease specialist, said in opening the discussion period that followed. “There were so many statements I don’t agree with that it’s hard to be succinct.” His comments were repeatedly interrupted by acting chair Robert Malone, who tried to limit Meissner’s remarks to questions. “You’re opining rather than asking questions,” Malone said. Meissner responded that he was stating facts. This afternoon, ACIP will vote on a recommendation to move away from the current practice of a birth dose of the HBV vaccine for all infants born in the U.S.

CTAD 2025: Diagnosing semaglutide’s failure in Alzheimer’s disease

A little over a week after announcing that the Evoke and Evoke+ studies failed to show that oral semaglutide could slow cognition decline in patients with Alzheimer’s disease, investors and researchers got the first look at the actual data from Novo Nordisk A/S’ studies, which were presented at the Clinical Trials in Alzheimer’s Disease 2025 meeting. Unfortunately, the changes in cognition were virtually the same between patients taking the GLP-1 receptor agonist semaglutide and placebo. Furthermore, patients taking placebo performed as expected on the cognitive tests, suggesting the clinical trials were executed properly. Nevertheless, investigators were willing to hypothesize as to why the initial positive signals suggesting semaglutide might help patients didn’t translate into a phase III success.

BMS meets readout delay in phase III AD psychosis effort with Cobenfy

One player in the quest for a new treatment for Alzheimer’s disease psychosis (ADP), Bristol Myers Squibb Co. (BMS), said Nov. 3 that sign-ups will continue in the phase III Adept-2 study with Cobenfy (xanomeline and trospium chloride) despite “irregularities” found at a number of study sites. Data from those locations will be excluded, and the study readout has been pushed to the end of 2026, a holdup of about one year. The BMS hitch amounts to good news for such competitors as Acadia Pharmaceuticals Inc., which expects to have phase II/III results from the ADP study called Radiant with 5-HT2A receptor inverse agonist ACP-204. Cobenfy pairs a muscarinic agonist with a muscarinic antagonist, and was approved by the U.S. FDA last year for schizophrenia.

Guidance on primate testing is ‘genuine’ animal welfare progress

On Dec. 2, 2025, the FDA released draft guidance that could reduce the use of nonhuman primates (NHPs) in preclinical testing of monoclonal antibodies. According to the guidance, which the FDA released for the purpose of soliciting comments, “In general, studies longer than 3 months in nonrodent species (e.g., NHPs, dogs, and mini-pigs) are not warranted to evaluate toxicities … when data from 3-month studies are supplemented with a weight-of-evidence (WoE) risk assessment.”

Aimedbio debuts with $48M Kosdaq IPO

Aimedbio Inc. raised ₩70.73 billion (US$48.24 million) in its Dec. 4 IPO, marking the largest Kosdaq listing this year. Shares of the cancer drug biotech (KOSDAQ:0090K0) surged 300% on opening day, closing at ₩44,000 each. Aimedbio priced the offering of 6.43 million shares at ₩11,000 per share on Nov. 20, with Mirae Asset Securities Co. Ltd. as lead underwriter. “We plan to further enhance our new drug development platform, accelerate pipeline expansion and strengthen our in-house clinical capabilities in the global market,” said Aimedbio CEO Her Nam-gu.

Laigo raises €11.5M seed money for targeted protein degradation

Laigo Bio BV has raised €11.5 million (US$13.7 million) in a seed round for the further development of a new approach to inducing targeted protein degradation by E3 ubiquitin ligases. The technology uses multivalent antibodies that simultaneously bind to both cell surface protein targets and a cell surface E3 ligase, prompting the transfer of ubiquitin to the target(s) and tagging them for degradation by the proteosome or lysosome. Riffing off the first molecules designed to harness E3 ligases, Proteolysis targeting chimeras, or Protacs, Laigo calls its constructs Surface removal targeting chimeras, or Suretacs.

Minerva jumps on phase III funding, leading neuro stocks

Stocks on the BioWorld Neurological Diseases Index posted mixed performance over the past three months, led by Minerva Neurosciences Inc.'s gains after securing $200 million to advance roluperidone, and by renewed optimism around Design Therapeutics Inc. and Ovid Therapeutics Inc. following clinical progress.

Also in the news

ADC, Aobiome, Actithera, Auxilius, BCM, Biocardia, Biogen, Biontech, Black Diamond, BMS, Capricor, Celltrion, Clene, Corrixr, Curevac, Dimerx, Eisai, Elevar, Formosa, Iliad, Inhatarget, Iolyx, Junevity, Laboratoires Thea, Lantern, March, Merxin, Muvon, Nuvation, Onco3r, Oncotelic, Pharvaris, Polypid, Quadriga, Realta, Rxilient, Thryv, Triana, Vaximm