Thumbs Down From FDA Panel on Plastic Meniscus Replacement
An FDA advisory committee voted 6-2, with one absention, that a novel, synthetic knee meniscus replacement’s benefits do not outweigh its risks, and thus is not suitable for marketing. Members of the Orthopaedic and Rehabilitation Devices Panel of the FDA’s Medical Devices Advisory Committee said the efficacy data were too weak, and a nearly 50% […]
Most New Drugs Exceeded $200,000; S.C. Abortion Ban Tossed; Sen. Casey’s Cancer
Note that some links may require subscriptions. The median annual price of novel FDA approved drugs exceeded $200,000 in 2022. (Reuters) As COVID tears through Beijing, hospital beds are becoming scarce, and running out at some hospitals. (AP) The South Carolina Supreme Court struck down the state’s 6-week abortion ban, deeming it unconstitutional. (CNBC) Meanwhile, […]
Topical Gene Therapy Heals Blistering Skin Disease Lesions
A novel topical gene therapy healed most lesions among patients with dystrophic epidermolysis bullosa, a rare genetic blistering skin disease, the GEM-3 trial showed. Topical administration of beremagene geperpavec (B-VEC) led to complete healing of 67% of treated wounds as compared with 22% of those exposed to placebo at 6 months (P=0.002), reported M. Peter […]
High Rates of pCR With Novel Neoadjuvant Combination for Breast Cancer
SAN ANTONIO — A novel neoadjuvant regimen for HER2-negative breast cancer doubled the pathologic complete response (pCR) rate as compared with standard chemotherapy, a small phase II study showed. Across various breast cancer receptor signatures, pCR rates ranged from 36% to 53% with the combination of paclitaxel, the PD-1 inhibitor cemiplimab (Libtayo), and the investigational […]
Dementia Risk Score Touts ‘Nearly 100%’ Predictive Accuracy
A novel clinical risk score predicted the chance of future dementia with high accuracy, but raised questions from dementia experts. Using data from nearly 450,000 people in the U.K. Biobank cohort, Xi-jian Dai, PhD, of The Second Affiliated Hospital of Nanchang University in China, and colleagues developed a practical tool to predict individual risk of […]
Targeted Combo Flops as First-Line Treatment in Advanced Breast Cancer
PARIS — A novel combination failed to improve the clinical benefit rate (CBR) in advanced triple-negative breast cancer (TNBC) compared with chemoimmunotherapy, a randomized trial showed. Adding the anti-CD73 antibody oleclumab to durvalumab (Imfinzi) and chemotherapy led to clinical benefit (response plus stable disease) in 43% of patients by 24 weeks as compared with 44% […]
Rezvilutamide Bests Bicalutamide in Metastatic Prostate Cancer
In combination with androgen deprivation therapy (ADT), the novel androgen-receptor inhibitor rezvilutamide significantly improved radiographic progression-free survival (PFS) and overall survival (OS) compared with bicalutamide (Casodex) in patients with high-volume, metastatic, hormone-sensitive prostate cancer, the phase III CHART trial showed. Among 654 mostly Asian patients, median radiographic PFS was not reached in the rezvilutamide group […]
Novel Focal Therapy Yields Low Rate of Serious Prostate Cancers
The use of a novel focal therapy technique called high-frequency irreversible electroporation (H-FIRE) for the treatment of localized prostate cancer resulted in a 6-month clinically significant prostate cancer (csPCa) rate lower than previously seen with other energy platforms, according to Chinese investigators. Among the 100 patients who received H-FIRE and were biopsied at 6 months, […]
Whopping Mortality Benefit in Severe COVID Trial
Treatment with a novel, oral microtubule disruptor significantly reduced the risk of death in hospitalized COVID-19 patients with severe disease, an interim analysis of a phase III study indicated. Mortality at 60 days, the international trial’s primary endpoint, was more than halved in the group assigned to investigational sabizabulin versus those randomized to placebo (20.2% […]
No more binge eating: Signal pathway in the brain that controls food intake discovered
A group of researchers has developed an entirely novel approach to treating eating disorders. The scientists showed that a group of nerve cells in the hypothalamus (so-called AgRP, agouti-related peptide neurons) control the release of endogenous lysophospholipids, which in turn control the excitability of nerve cells in the cerebral cortex, which stimulates food intake. In […]