article thumbnail

Many Older People Embrace Vaccines. Research Is Proving Them Right.

Physician's Weekly

Kim Beckham, an insurance agent in Victoria, Texas, had seen friends suffer so badly from shingles that she wanted to receive the first approved shingles vaccine as soon as it became available, even if she had to pay for it out-of-pocket. So, in 2016, she celebrated her 60th birthday at her local CVS. Kennedy Jr.,

article thumbnail

FDA’s Accelerated Approval of Biogen’s Aduhelm for Alzheimer’s: A Sign of Applying the Emergency Use Standard Beyond COVID?

FDA Law

This sentence was included in the 2016 approval of Exondys 51 for Duchenne muscular dystrophy and the 2018 approval of Andexxa for reversal of anticoagulation therapy. This has been a decision we’ve been closely following. Key Takeaways from the Aduhelm Label: What’s in It and What Isn’t. What do we mean?

Clinic 98
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Can the Tropical PRV Have Its Moment (Again?) – Not all Priority Review Vouchers are Created Alike: What the Potential Loss of the Rare Pediatric PRV Could Mean for the Tropical Disease PRV Program

FDA Law

2014) June 2016 Vaxchora (Pax Vax Bermuda) Cholera vaccine for travelers $ 290 (June 2016) Aug 2017 Benznidazole (Chemo Research) Chagas disease UNK June 2018 Moxidectin (Medicines Devt for Global Health) Onchocerciasis, or river blindness UNK (May 2019) July 2018 Krintafel (GSK) P.

IT 52
article thumbnail

Every Claim You Make, Every Step You Take…CVM Will Be Watching You

FDA Law

Zenrelia comes with serious warnings, including a boxed warning against the use of Zenrelia during vaccination. CVM also objected to the truncation of other information about the timing of vaccines in these promotional materials. Zenrelia promotional materials also included claims about clinical data that the Agency found actionable.

article thumbnail

A Review of H5N1

Alabama Academy of Family Physicians

Since 2016, HPAI H5N1 has been detected in wild birds in the United States during screening efforts by wildlife authorities. Also, CDC has provided a candidate vaccine virus to manufacturers for rapid production if needed. H5N1 is currently known to be widespread among wild birds and is thought to be spread by migratory waterfowl.

article thumbnail

Aging and Homelessness: Margot Kushel

GeriPal

How has the history of redlining and the federal tax subsidy of wealthy (mostly white) people in the form of a mortgage interest deduction contributed to racial inequalities in homelessness? What can we do about it? What are the highest yield interventions and policy changes? What should we call it – homeless or unhoused? Eric: I love this.

article thumbnail

Drug Pricing Reform Gathers Steam (Part 2)

FDA Law

For drugs approved before July 1, 2015, the baseline quarter is 1Q 2016, and for drugs approved after that date, the baseline quarter is the third full quarter after launch. The Part B rebate would exclude vaccines as well. Both the Part B and Part D rebates would be excludable from ASP and Medicaid Rebate best price.