Pfizer, BioNTech Say Omicron Shot Offers More Protection Than Original Vax

Updated phase 2/3 trial data from Pfizer and BioNTech show that adults who received the companies’ bivalent booster had four times higher protection against the Omicron variant and its sublineages than they did after receiving the original COVID-19 vaccine booster, Pfizer and BioNTech announced Friday (Nov. 4).

Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/11/2022
FDA Volume: 
Vol. 28, No. 45
Author: 


Rubio Backs Importing Canadian Price Controls; Opposes US Price Controls

A day after the president was in Florida attacking Republicans on Medicare, five Republican Florida lawmakers, including Sen. Marco Rubio, urged the Biden administration to approve Florida’s plan to import Canadian drugs.

Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 11/07/2022
IDP Volume: 
Vol. 5, No. 45
Author: 

CDC: Telehealth Among Accepted Modalities For Supporting Opioid Tapering

Telehealth visits including audio visits are now one of the accepted modalities for clinicians to monitor patients tapering their opioid use, according to new guidance the Centers for Disease Control and Prevention put out Thursday (Nov.3) for clinicians prescribing opioids for pain.

Site Name: 
InsideHealthPolicy.com
Author: 

Warner Floats Requiring Cyber Controls To Participate In Medicare

Senate Intelligence Chairman Mark Warner (D-VA) says the health care sector is uniquely vulnerable to cybersecurity attacks, and Thursday (Nov. 3) floated potential solutions including making cybersecurity requirements a condition for providers to participate in Medicare, setting up a health care cyber framework, reforming HIPAA, tightening software security, and improving coordination among federal health and cyber officials.

Site Name: 
InsideHealthPolicy.com
Author: 
Secondary Author(s): 

Warner Floats Requiring Cyber Controls To Participate In Medicare

Senate Intelligence Chairman Mark Warner (D-VA) says the health care sector is uniquely vulnerable to cybersecurity attacks, and Thursday (Nov. 3) floated potential solutions including making cybersecurity requirements a condition for providers to participate in Medicare, setting up a health care cyber framework, reforming HIPAA, tightening software security, and improving coordination among federal health and cyber officials.

Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/11/2022
FDA Volume: 
Vol. 28, No. 45
CMS Issue: 
Inside CMS - 11/10/2022
CMS Volume: 
Vol. 25, No. 45
Author: 
Secondary Author(s): 

Panel Backs FDA Plan To Expand KASA Platform To New Drugs, Biologics

A panel of FDA advisers unanimously supported the agency’s plan to expand its generic drug quality review platform to also include new drugs, biologics and post-approval changes over the next five years.

Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/11/2022
FDA Volume: 
Vol. 28, No. 45
Author: 

FDA: Lilly’s COVID Drug Not Expected To Work Against BQ.1, BQ.1.1

FDA on Friday (Nov. 4) cautioned health care providers that Eli Lilly’s COVID-19 monoclonal antibody bebtelovimab is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1, which comprise about 17% and 19% of coronavirus cases in the United States, respectively.

Site Name: 
InsideHealthPolicy.com
FDA Issue: 
FDA Week - 11/11/2022
FDA Volume: 
Vol. 28, No. 45
Author: 




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