IN THIS ISSUE

December 17, 2022


  • COVID-19 Updates
  • Upcoming Events
  • Addressing Pharmacy Deserts One Store at a Time
  • APhA Annual Meeting and Exposition
  • Indiana Regulatory Update
  • Federal Regulatory Update
  • Drug Approval News
  • FDA New Drug Approvals
COVID-19 UPDATES

Top Headlines

HHS Releases Long COVID Report Providing Insights and Opportunities to Support Patient Community

Researchers have compiled together the Health+ Long COVID report, which includes insights directly from patients and specific recommendations for health care providers that can help patient receive better care related to COVID. In addition, the Biden administration has requested $750 million to support long COVID research and treatment. Read more here.


FDA Relaxes EUA Advertising Limitation for Some COVID Drugs

Conditions in EUA letters for six drug program have been updated and these products may now be promoted with "accurate descriptions of safety results and efficacy results on a clinical endpoint(s) from the clinical trial(s) summarized in the authorized labeling." Read more here.


FDA Pauses Authorization Of Eli Lilly's COVID-19 Monoclonal Antibody Treatment Bebtelovimab

The drug product is now currently not authorized for emergency use in the U.S. as it is not expected to neutralize the dominant subvariants of Omicron. Read more here.




Upcoming Events
All times ET

How to Elevate Your Personal Brand to a Strategic Plan-Webinar


January 10, 2023, 12:15 p.m.

Register



Advocacy Training

Learn about IPA's 2023 Legislative Agenda and how to be an advocate


January 10, 2023, 1:00 p.m.

Register


Save the Date!


IPA Legislative Day

Tuesday, January 24, 2023

Statehouse

9 a.m. - 4 p.m.


Registration link here

FDA Issues an Emergency Use Authorization for Lucira COVID-19 and Flu Test

This test is designed to detect both the SAR-CoV-2 virus and influenza (types A and B) in patient who may have respiretory viral infection symptoms consist with COVID-19. Read more about the test here.

Donate to the Pharmacy Education Foundation

on Amazon Smile


Do your Christmas shopping using Amazon Smile, Amazon donates to PEF at no cost to you!

Addressing Pharmacy Deserts One Store at a Time

Underserved communities suffer from worse health outcomes from a lack of access, care, and services for their needs. McKesson aims to help address pharmacy deserts, one store at a time. To find out more click here.


McKesson wants to team up with a licensed pharmacist to help them establish their own pharmacy in an underserved community, providing access and changing health outcomes for at-risk populations. To find out more click here.

APhA Annual Meeting and Exposition

The American Pharmacists Association’s annual meeting is now open for registration! APhA2023 will be held in Phoenix on March 24–27, 2023.


If you’re interested in attending, APhA is offering an exclusive discount to state association members. Save an additional $75 off the full pharmacist early-bird registration rate, good through January 26, 2023. To apply the $75 discount, simply enter the promo code STATE75 at checkout.


The early-bird registration fees this discount applies to are as follows. The pricing below is prior to the discount being applied:

Member full conference: $760

Federal member full conference: $760

Nonmember full conference: $1,150

Federal pharmacist nonmember full conference: $865


Register now and save $75 using promo code STATE75.

Indiana Regulatory Update

BT2022113 – IHCP updates Preferred Diabetes Supply List

BT2022110 – Pharmacy updates approved by Drug Utilization Review Board November 2022

BT2022108 – IHCP revises billing guidance for pediatric vaccine counseling services

BT2022106 – IHCP adds coverage for Moderna and Pfizer COVID-19 bivalent vaccine booster codes

BT2022105 – IHCP adds coverage for Novavax COVID-19 booster vaccine

Federal Regulatory Update

PIE Act Gains Bipartisan Momentum Ahead of End-of-Year Push

The PIE Act, was reintroduced to Congress last month. The proposal’s core tenet allows payers to review new treatments alongside the FDA, saving months or years that could be the ultimate difference for some Americans, without sacrificing safety or standards.

Drug Approval News

Industry Dive: FDA Approves Rezvoglar As Second ‘Interchangeable’ Insulin Biosimilar

Eli Lilly's long acting insulin Rezvoglar is approved by FDA, making it the second insulin biosimilar to receive the valuable designation. Read more about it here.


1st Ever Drug to Delay Type 1 Diabetes Approved by FDA

On November 17th, FDA announced that Tzield, an monoclonal antibody drug, is approved to help prevent Type I diabetes in those who are destined to develop the disease. Read the article here.


Drugstore News: 12 Exciting Generic Introductions That Recently Hit the Market

Generic drug companies have launch a number of generics and biosimiliars in a broad range of therapeutic categories, including dermatology, oncology, antibiotics and more. Read more about it here.

FDA New Drug Approvals

FDA New Drug Approvals - September 2022


Spevigo - injection, for intravenous use. Initial U.S. Approval: 9/1/2022, for the treatment of generalized pustular psoriasis flares. Manufactured by: Boehringer Ingelheim Pharmaceuticals, Inc.


Daxxify - injection, for intramuscular use. Initial U.S. Approval: 9/7/2022, for the treatment of moderate-to-severe glabellar lines associated with corrugator and/or procerus muscle activity. Manufactured by: Revance Therapeutics, Inc.


Rolvedon - injection, for subcutaneous use. Initial U.S. Approval: 9/9/2022, used to decrease the incidence of infection in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia. Manufactured by: Spectrum Pharmaceuticals, Inc.


Sotyktu - tablets, for oral use. Initial U.S. Approval: 9/9/2022, for the treatment of moderate-to-severe plaque psoriasis. Manufactured by: Bristol-Myers Squibb Company.


Terlivaz - injection, for intravenous use. Initial U.S. Approval: 9/14/2022, used to improve kidney function in adults with hepatorenal syndrome with rapid reduction in kidney function. Manufactured by: Mallinckrodt Pharmaceuticals.


Elucirem - injection, for intravenous use. Initial U.S. Approval: 9/21/2022, used to detect and visualize lesions, together with MRI, with abnormal vascularity in the central nervous system and the body. Manufactured by: Liebel-Flarsheim Company LLC.


Omlonti - 0.002% ophthalmic solution, for topical ophthalmic use. Initial U.S. Approval: 9/22/2022, used to reduce elevated intraocular pressure in patients with open‑angle glaucoma or ocular hypertension. Manufactured by: Santen Inc.


Relyvrio - oral suspension. Initial U.S. Approval: 9/29/2022, used to treat amyotrophic lateral sclerosis (ALS). Manufactured by: Amylyx Pharmaceuticals, Inc.


Lytgobi - tablets, for oral use. Initial U.S. Approval: 9/30/2022, used to treat intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. Manufactured by: Taiho Pharmaceutical Co., Ltd.


FDA New Drug Approvals - October 2022


Imjudo - injection, for intravenous use. Initial U.S. Approval: 10/21/2022, used to treat unresectable hepatocellular carcinoma. Manufactured by: AstraZeneca Pharmaceuticals LP.

Tecvayli - injection, for subcutaneous use. Initial U.S. Approval:10/25/2022, used to treat relapsed or refractory multiple myeloma among adults who have received at least four specific lines of therapy. Manufactured by: Janssen Biotech, Inc.

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