Biopharma companies and their lobbying groups were stung in early October when a historic trade pact proposal failed to include 12 years of data exclusivity for biologic medicines. Instead, the ...Trans-Pacific Partnership (TPP), if ratified by all Pacific Rim member nations, will offer five years data exclusivity.
The first cyclin-dependent kinase 4/6 (CDK4/6) inhibitor was okayed by the US Food and Drug Administration (FDA) February 3, as New York-based Pfizer received accelerated approval for Ibrance ...(palbociclib) based on phase 2 data. The drugs go-ahead is for use as a frontline treatment in combination with letrozole (Femara), a standard anti-estrogen therapy, in postmenopausal women with estrogen receptor (ESR)-positive human epidermal growth factor receptor-2 (HER2)-negative (ESR+/HER2) advanced breast cancer.
Persistent cognitive symptoms have been reported following COVID-19 hospitalization. We investigated the relationship between demographics, social determinants of health (SDOH) and cognitive outcomes ...6-months after hospitalization for COVID-19.
We analyzed 6-month follow-up data collected from a multi-center, prospective study of hospitalized COVID-19 patients. Demographic and SDOH variables (age, race/ethnicity, education, employment, health insurance status, median income, primary language, living arrangements, and pre-COVID disability) were compared between patients with normal versus abnormal telephone Montreal Cognitive Assessments (t-MOCA; scores<18/22). Multivariable logistic regression models were constructed to evaluate predictors of t-MoCA.
Of 382 patients available for 6-month follow-up, 215 (56%) completed the t-MoCA (n = 109/215 51% had normal and n = 106/215 49% abnormal results). 14/215 (7%) patients had a prior history of dementia/cognitive impairment. Significant univariate predictors of abnormal t-MoCA included older age, ≤12 years of education, unemployment pre-COVID, Black race, and a pre-COVID history of cognitive impairment (all p < 0.05). In multivariable analyses, education ≤12 years (adjusted OR 5.21, 95%CI 2.25–12.09), Black race (aOR 5.54, 95%CI 2.25–13.66), and the interaction of baseline functional status and unemployment prior to hospitalization (aOR 3.98, 95%CI 1.23–12.92) were significantly associated with abnormal t-MoCA scores after adjusting for age, history of dementia, language, neurological complications, income and discharge disposition.
Fewer years of education, Black race and unemployment with baseline disability were associated with abnormal t-MoCA scores 6-months post-hospitalization for COVID-19. These associations may be due to undiagnosed baseline cognitive dysfunction, implicit biases of the t-MoCA, other unmeasured SDOH or biological effects of SARS-CoV-2.
•Abnormal telephone MoCA scores occurred in 49% of patients 6-months after hospitalization for COVID-19.•Cognitive impairment was independent of any hospital metric or measure of COVID-19 illness severity.•Black race, ≤12 years of education, and pre-hospitalization unemployment with disability predicted impaired cognition.•These associations may be due to undiagnosed baseline cognitive deficits, implicit testing biases, or other SDOH.
As the first and only approved gene therapy in Europe or the US, Glybera (alipogen tiparvovec) will likely become a benchmark product. Glybera was recommended for approval by the European Medicines ...Agency in 2012, and Chiesi plans to launch the product in Europe in early 2015, though it has yet to receive a nod from the US Food and Drug Administration (FDA).
The biopharmaceutical industry’s positive regulatory momentum carried on through 2019, despite an early-year government shutdown, a data manipulation scandal around a high-profile approval, and many ...months without permanent leadership at the FDA.
The FDA approved record numbers of new molecular entities, orphan drugs, small-molecule generics and biosimilars in 2018. Could industry’s regulatory success of the past two years become the new ...normal?
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