“It has been a year like no other in recent memory for public health at the U.S. Food and Drug Administration (FDA), with much of our focus has been dominated by our response to the COVID-19 pandemic,” stated Stephen M. Hahn, M.D., Commissioner.
Multinational Phase 2 Clinical Trial Launches Novel Immunotherapeutic for the Treatment of Chronic Hepatitis B
A Maryland-based biopharmaceutical company announced that it had enrolled the first patient in its multinational Phase 2 clinical trial of HepTcell, a novel peptide-based immunotherapeutic under development to treat chronic hepatitis B (CHB).
HepTcell is a novel immunotherapeutic composed of nine synthetic HBV-derived peptides formulated with IC31®, a TLR9-based adjuvant from Valneva SE. The HBV peptides are designed to drive T cell responses against all HBV genotypes in patients of diverse genetic backgrounds.
Secondary Bloodstream Infections Tied to Poorer COVID-19 Outcomes
Altered mental status, ICU admission, higher in-hospital mortality more likely in hospitalized patients with severe COVID-19 and sBSI
U.K. Is First Country to Approve Oxford-AstraZeneca COVID-19 Vaccine
Vaccine could become the dominant form of inoculation because at $3 to $4 a dose, it is a fraction of the cost of other vaccines
More Dangerous Mouthwashes and Hand Sanitizers Recalled
Hand sanitizer recall due to presence of methanol; oral rinse recall due to possible contamination with bacteria
Physician’s Briefing Weekly Coronavirus Roundup
Here is what the editors at Physician’s Briefing chose as the most important COVID-19 developments for you and your practice for the week of Dec. 28 to 30, 2020. This …
Gaps Found in Opioid Use Disorder Treatment During Pandemic
Percentage of patients receiving at least one urine test lower in March through May of 2020 versus 2019
Inequities Seen in Accessing Telemedicine During COVID-19
Factors linked to fewer completed telemedicine visits include older age, Asian race, non-English as preferred language, Medicaid insurance
Anticoagulants Not Tied to Higher Risk for GI Bleed in COVID-19
3 percent of hospitalized COVID-19 patients experience gastrointestinal bleeding
Another COVID-19 Vaccine Candidate Begins Final Clinical Trials
Novavax vaccine needs only standard refrigeration, not freezing or ultracold temperature storage