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FDA Approves Omisirge to Reduce Infection Risk in Blood Cancer Patients Undergoing Stem Cell Transplant
FDA Approves Omisirge to Reduce Infection Risk in Blood Cancer Patients Undergoing Stem Cell Transplant
FDA Approves Omisirge to Reduce Infection Risk in Blood Cancer Patients Undergoing Stem Cell Transplant
April 19, 2023
Omisirge is a stem cell therapy that helps the body recover more quickly from cancer treatments that kill normal blood cells along with blood cancer cells, thus lowering the risk of infection.
FDA Clears Rizafilm to Treat Acute Migraine
FDA Clears Rizafilm to Treat Acute Migraine
FDA Clears Rizafilm to Treat Acute Migraine
April 19, 2023
The film version may be well-suited for many patients who have migraine-related nausea, says the president of the company that developed the medication.
  FDA Declines to Approve Lilly’s Ulcerative Colitis Drug
  FDA Declines to Approve Lilly’s Ulcerative Colitis Drug
FDA Declines to Approve Lilly’s Ulcerative Colitis Drug
April 17, 2023
The FDA cited issues related to the proposed manufacturing of the drug, mirikizumab. Lilly expressed confidence that they could be corrected.
HyQvia Receives Expanded FDA Approval for Pediatric Primary Immunodeficiency
HyQvia Receives Expanded FDA Approval for Pediatric Primary Immunodeficiency
HyQvia Receives Expanded FDA Approval for Pediatric Primary Immunodeficiency
April 14, 2023
HyQvia is the first FDA-approved treatment for primary immunodeficiency (PI) available as a once-a-month subcutaneous injection. Other treatments for PI, while similarly effective, present a greater burden to patients, often requiring more frequent injections or more invasive routes of administration
New Express Scripts Programs Aim to Boost Affordability, Transparency
New Express Scripts Programs Aim to Boost Affordability, Transparency
New Express Scripts Programs Aim to Boost Affordability, Transparency
April 13, 2023
Through Express Scripts’ new Copay Assurance plan, consumers will have lower out-of-pocket costs because of caps on prescription drugs: $5 for generics, $25 for preferred brand drugs, and $45 for preferred specialty brand drugs.
U.S. Payers May Find Tirzepatide Costs Acceptable Given the Treatment Benefits in Patients with Type 2 Diabetes
U.S. Payers May Find Tirzepatide Costs Acceptable Given the Treatment Benefits in Patients with Type 2 Diabetes
U.S. Payers May Find Tirzepatide Costs Acceptable Given the Treatment Benefits in Patients with Type 2 Diabetes
April 12, 2023
Tirzepatide was associated with a greater reduction in hemoglobin A1c and body weight versus semaglutide. Though, with a current list price of $1,023 for a one-month supply of tirzepatide (Mounjaro; Lilly), is it worth it?
AbbVie Withdraws Two Blood Cancer Indications From Imbruvica
AbbVie Withdraws Two Blood Cancer Indications From Imbruvica
AbbVie Withdraws Two Blood Cancer Indications From Imbruvica
April 11, 2023
Other indications for the blockbuster cancer mediation are not affected.
Healthcare Groups, Legislators Slam Texas Mifepristone Ruling
Healthcare Groups, Legislators Slam Texas Mifepristone Ruling
Healthcare Groups, Legislators Slam Texas Mifepristone Ruling
April 10, 2023
This case and a case in Washington state are likely to be appealed to the Supreme Court.
FDA Officially Withdraws Makena, the Only Preterm Birth Med
FDA Officially Withdraws Makena, the Only Preterm Birth Med
FDA Officially Withdraws Makena, the Only Preterm Birth Med
April 7, 2023
Issued jointly by the FDA Commissioner and Chief Scientist, the decision means Makena and its generics are no longer approved and cannot lawfully be distributed in interstate commerce. At the same time, the agency “recognizes that there is a supply of product that has already been distributed.”
FDA Grants Emergency Use Authorization to Gohibic for Critically Ill COVID-19 Patients
FDA Grants Emergency Use Authorization to Gohibic for Critically Ill COVID-19 Patients
FDA Grants Emergency Use Authorization to Gohibic for Critically Ill COVID-19 Patients
April 6, 2023
The FDA granted the EUA based on the PANAMO phase 3 clinical trial results demonstrating that vilobelimab improved survival compared to placebo, with a 23.9% relative reduction in all-cause mortality at 28 days.
FDA Grants Accelerated Approval for Padcev - Keytruda Combo
FDA Grants Accelerated Approval for Padcev - Keytruda Combo
FDA Grants Accelerated Approval for Padcev - Keytruda Combo
April 5, 2023
The combination of Padcev with Merck’s Keytruda has a potentially large market: approximately 8,000 to 9,000 U.S. patients would be eligible for this combination in the U.S.
Could Copay Assistance Narrow Health Inequities?
Could Copay Assistance Narrow Health Inequities?
Could Copay Assistance Narrow Health Inequities?
April 4, 2023
A study funded by Genentech showed that the assistance programs substantially reduce prescription abandonment regardless of race or income level.
New York Launches PBM for Medicaid Beneficiaries
New York Launches PBM for Medicaid Beneficiaries
New York Launches PBM for Medicaid Beneficiaries
April 3, 2023
State officials say the new NYRx program will mean fewer restrictions and create a largest pharmacy network in the state.
New Insulin Cap Bill Lauded, But Caution Urged
New Insulin Cap Bill Lauded, But Caution Urged
New Insulin Cap Bill Lauded, But Caution Urged
March 31, 2023
A bipartisan Senate bill, Affordable Insulin Now Act of 2023, would require plans to cover insulin for no more than $35 per month.
Second Senate Committee Heaps Criticism on PBMs
Second Senate Committee Heaps Criticism on PBMs
Second Senate Committee Heaps Criticism on PBMs
March 30, 2023
Members of the Senate Finance Committee want to modernize the rules around PBM business practices to lower out-of-pocket costs and increase competition.
 FDA Clears Narcan OTC for Opioid Overdoses
 FDA Clears Narcan OTC for Opioid Overdoses
FDA Clears Narcan OTC for Opioid Overdoses
March 29, 2023
Emergent BioSolutions hasn’t provided a price for the nonprescription Narcan but said the product will be available by late summer.
FDA Schedules Advisory Committee Meeting for OTC Contraceptive
FDA Schedules Advisory Committee Meeting for OTC Contraceptive
FDA Schedules Advisory Committee Meeting for OTC Contraceptive
March 29, 2023
If approved, Perrigo’s Opill could be the first-ever nonprescription birth control pill.
Ohio Sues Express Scripts and Prime Therapeutics For Price Fixing
Ohio Sues Express Scripts and Prime Therapeutics For Price Fixing
Ohio Sues Express Scripts and Prime Therapeutics For Price Fixing
March 28, 2023
The suit alleges that Express Scripts, Prime and Prime customer Humana Pharmacy Solutions are able to share drug pricing and rebate information to increase prices for insulins, biologics and cancer drugs.
Generics Keep Out-of-Pocket Costs Low for Women with Breast Cancer
Generics Keep Out-of-Pocket Costs Low for Women with Breast Cancer
Generics Keep Out-of-Pocket Costs Low for Women with Breast Cancer
March 28, 2023
Out-of-pockets costs were higher among those using branded or more recently launched drugs.
RxBenefits Provides New Solutions to Facilitate Access to Patient Assistance Programs
RxBenefits Provides New Solutions to Facilitate Access to Patient Assistance Programs
RxBenefits Provides New Solutions to Facilitate Access to Patient Assistance Programs
March 27, 2023
RxBenefits helps patients in self-funded plans find and apply for alternative sources of funding for specialty medicines and facilitates enrollment.
FDA Approves First Treatment for Rare Immunodeficiency Disease
FDA Approves First Treatment for Rare Immunodeficiency Disease
FDA Approves First Treatment for Rare Immunodeficiency Disease
March 27, 2023
Leniolisib, now with the brand name Joenja, treats APDA, a genetic disorder that impairs the immune system. It will have an annual list price of $547,500 a year.
FDA Clears First New Treatment for Invasive Candidiasis in 10 Years
FDA Clears First New Treatment for Invasive Candidiasis in 10 Years
FDA Clears First New Treatment for Invasive Candidiasis in 10 Years
March 24, 2023
Rezzayo is a novel once-weekly antifungal approved to treat invasive candidiasis, a serious infection that can affect the blood, heart and brain.
Committee Sends PBM Transparency Bill to Full Senate
Committee Sends PBM Transparency Bill to Full Senate
Committee Sends PBM Transparency Bill to Full Senate
March 23, 2023
The proposed legislation, sponsored by Sens. Chuck Grassley and Maria Cantwell, aims to increase transparency of PBM business practices.
California Selects Generic Company Civica Rx as Insulin Partner
California Selects Generic Company Civica Rx as Insulin Partner
California Selects Generic Company Civica Rx as Insulin Partner
March 22, 2023
CalRx will work with Civica to provide the most commonly used short- and long-acting insulins at planned prices of no more than $30 a vial and $55 for a box of five pre-filled pens.
Hyrimoz, a High-Concentration Humira Biosimilar, Approved by FDA
Hyrimoz, a High-Concentration Humira Biosimilar, Approved by FDA
March 22, 2023
Sandoz will now launch both high-concentration and low-concentration versions of Hyrimoz (adalimumab-adaz) in July.
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