Remove Definition Remove Packaging Remove Vaccine
article thumbnail

AstraZeneca’s COVID-19 Vaccine Boasts Strong Results with Up to 90% Efficacy

The Pharma Data

As the Pfizer and BioNTech COVID-19 vaccine goes to regulators and the Moderna vaccine approaches the end of its Phase III trials, AstraZeneca and the University of Oxford announced high-level results from an interim analysis of their COVID-19 vaccine, AZD1222. The combined analysis showed average efficacy of 70%.

Vaccine 52
article thumbnail

CMS Final Medicaid Drug Rebate Rule Details New Misclassification Penalties and Numerous Other Changes

FDA Law Blog: Biosimilars

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. that is not supported by the statute and applicable regulations.” 1396r-8(k)(3).

Drugs 57
Insiders

Sign Up for our Newsletter

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

article thumbnail

ChEMBL 34 is out!

The ChEMBL-og

A significant effort has been made to correctly map the drug form of the EMA data by manually inspecting different EMA sources of information, such as the Product Information (Annex I: Summary of Product Characteristics and Annex III: Labelling and Package Leaflet) and/or Assessment Report, where available. University of Dundee: T.

article thumbnail

Spade SB-66

The Pharma Data

And why instead, by taking action today and selecting one of the packages you see below…. By clicking on one of the packages you see beneath this video right now…. Once you’ve selected your package of Spade SB-66… You’ll be taken to our 100% encrypted and secure checkout page…. And actually, that’s still just the start.

article thumbnail

The Forgotten Pandemic

Codon

The second part — focused on vaccines and medicines — will be published next Sunday, concluding Issue 04 of Asimov Press. Identifying the bacteria behind the pathogen would later set the stage for many upcoming diagnostics, treatments, and even a vaccine. But doctors explored numerous uninformed remedies in the interim.

article thumbnail

Analysis Life Sciences Thank You Halfway there: Novel drug approvals and their supportive clinical trials so far in 2024

Agency IQ

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved.

article thumbnail

Analysis Life Sciences Thank You FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms

Agency IQ

As such, it doesn’t review things like vaccines, blood products or gene therapies – those products are instead reviewed by CBER. While the definition of NME has changed over the years, it can sometimes include a combination product consisting of at least one drug that has previously been approved. What’s next? Stay tuned.

FDA 52