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The investigational agent – known as REGEN-COV (casirivimab and imdevimab) – was previously granted the Emergency Use Authorization (EUA) for the treatment of mild to moderate COVID-19. Now, those who are at high risk for progression to severe COVID-19, including hospitalization or death, have an option.
Allergy & Immunology August 9th 2021
JAMA Network
The additional approval expands immunization coverage to the most at-risk group for acquiring shingles – the immunocompromised. It also shortens the time to the second dose in the 2-dose Shingrix schedule. Decision support based on the Zoster Efficacy Study in Patients Undergoing HSCT (ZOE-HSCT) phase III trial (JAMA).
Allergy & Immunology August 3rd 2021
Trilaciclib (Cosela, G1 Therapeutics), a cyclin dependent kinase 4/6 inhibitor, is already approved in the United States to reduce frequency of chemotherapy-related bone marrow suppression among adults with extensive-stage small cell lung cancer. Now, the FDA has granted fast track designation to the drug for use in combo with chemo for treatment of locally advanced or metastatic TNBC.
Internal Medicine July 26th 2021
The FDA added a warning that Johnson & Johnson’s COVID-19 vaccine may trigger Guillain-Barré syndrome (GBS) in a small number of people. Of the 12.5 million Americans who received this vaccine, about 100 people reported having GBS, which is an acquired demyelinating polyneuropathy that often begins in the lower extremities and ascends over time with loss of reflexes, causing muscle weakness, or in the most severe cases, paralysis.
Emergency Medicine July 19th 2021
According to a press release from April 2021, “the FDA is working toward issuing proposed product standards within the next year to ban menthol as a characterizing flavor in cigarettes and ban all characterizing flavors (including menthol) in cigars.” Acting Commissioner Janet Woodcock, MD, said the agency had now “accumulated sufficient evidence establishing the addictiveness and harm from menthol,” which provides a “trajectory” toward ending tobacco-related disease and death.
Cardiology July 13th 2021
ASH Clinical News
The investigational new drug (IND) application is for GDX012, which also received an FDA orphan drug designation for the treatment of acute myeloid leukemia (AML). The drug’s manufacturer, GammaDelta Therapeutics, is developing the T-cell platform in partnership with Takeda and will initiate a phase I study in late 2021 that will evaluate the treatment’s safety and activity in patients with measurable residual disease-positive AML.
Hematology June 21st 2021