Boosters on the way: LTC residents, healthcare workers may top fed’s list after CDC approves 3rd shot
By
Alicia Lasek
Aug 16, 2021
The Biden administration has secured 100 million COVID-19 vaccine doses as part of a strategy to provide additional shots to already vaccinated priority groups this fall, investigators have been told....
FDA approves first biosimilar insulin product
Jul 29, 2021
Semglee (insulin glargine-yfgn) is biosimilar to and interchangeable with Lantus (insulin glargine), provides cost-effective option
FDA accelerates timetable for full approval of Pfizer vaccine
By
Danielle Brown
Aug 05, 2021
It may soon be “go” time for providers that have thus far held off on mandating COVID-19 vaccines for staff members, basing their decisions on the fact vaccines have been approved by the Food and...
FDA OKs new insulin biosimilar for type 2 diabetes
By
Alicia Lasek
Jul 30, 2021
Semglee is a safe and more cost-effective alternative to the drug Lantus (insulin glargine), the agency announced Wednesday. Semglee does not need a prescriber’s input to be substituted at the pharmacy.
First appropriate use guidance published for Alzheimer’s drug Aduhelm
By
Alicia Lasek
Jul 28, 2021
The new guidelines cover how to choose appropriate patients, safely scale up to a full dose, monitor side effects and assess effectiveness. The authors also address when to stop therapy and what patients...
Vaccinated long-term care residents in the clear from COVID-19 — for now
By
Danielle Brown
Jul 12, 2021
Long-term care residents and staff fully vaccinated against COVID-19 don’t need booster shots anytime soon, according to federal health officials.
Clinical briefs for Thursday, June 10
By
Alicia Lasek
Jun 10, 2021
Operator changes plans, will wait for full FDA approval to enforce COVID vaccination deadline among staff … Colorado drops mask mandate for assisted living communities … FDA panel member resigns over...
FDA approves first drug to slow Alzheimer’s in controversial decision
By
Alicia Lasek
Jun 07, 2021
The evidence convincingly shows that aducanumab (Aduhelm) removes beta amyloid — a hallmark of Alzheimer’s — from the brain, slowing the disease’s progression and giving patients and families much-needed...
FDA OKs third antibody COVID therapy; variants spur new pause on another
By
Alicia Lasek
Jun 01, 2021
A new COVID-19 treatment made by GlaxoSmithKline now is the third monoclonal antibody therapy federally authorized to help prevent severe disease outcomes in high-risk patients. But gene variants are interfering...
While FDA moves to halt mask reuse, N95 access remains spotty, report finds
By
Alicia Lasek
Apr 15, 2021
A new push to ensure that healthcare facilities stockpile single-use or reusable N95 respirators has arrived while some workers continue to lack access to the equipment and U.S. mask manufacturers can’t...