The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of Pfizer Inc.’s Emblaveo (aztreonam-avibactam), an antibiotic combination that would offer a new option to patients with serious bacterial infections caused by multidrug-resistant gram-negative bacteria. If approved, Emblaveo would be among the first beta-lactam/beta-lactamase inhibitor combos cleared for use in Europe.

After many years of testing different monoclonal antibodies against amyloid-β protein, the results obtained are far from being outstanding, and the control of the progression and symptoms of Alzheimer’s disease (AD) remains elusive. At the recent AD/PD 2024 conference held in Lisbon, new non-anti-amyloidogenic strategies in the starting line against AD were discussed. Professor Einar Sigurdsson from New York University gave a presentation entitled, “Single domain antibodies for therapy and diagnosis of synucleinopathies and tauopathies.”

Precision psychiatry got some love at two quite different meetings this week, the European Congress of Neuropsychopharmacology’s New Frontiers meeting and BioEurope Spring. The New Frontiers Meeting, an annual two-day meeting dedicated to cutting-edge issues in brain disease research, focused on big-picture and scientific – at times almost philosophical – questions of how to get to a classification scheme for brain disorders that aligns with the underlying biology.

At first glance, the number of drugs that received accelerated approval from the U.S. FDA’s Center for Drug Evaluation and Research (CDER) in 2023 was nothing to write home about. Yes, CDER granted nine accelerated approvals last year, up from six in 2022. But the proportion of novel drugs with accelerated approval was 16% both years. And when compared with the 12 drugs in 2020 and the 14 that received accelerated approval in 2021, last year’s crop was a little lackluster. However, a deeper look at the 2023 class of accelerated approvals shows a historic milestone. For the first time since the path was created in 1992, the number of novel biologics getting accelerated approval at CDER outpaced the number of small-molecule drugs.

In 2023, the BioWorld Neurological Diseases Index (BNDI) closed with a 4.36% increase, outperforming the Nasdaq Biotechnology Index (up 3.74%) but falling short of the surge seen in the Dow Jones Industrial Average (up 13.7%). The rebound marked a significant turnaround from November, when BNDI recorded an 18.37% year-to-date decline.

It’s the end of the development line for Acadia Pharmaceuticals Inc.’s main asset, pimavanserin. The company said it won’t conduct any more clinical studies on the selective serotonin inverse agonist and antagonist targeting 5-HT2A receptors after a phase III fail in schizophrenia.