Brexpiprazole Approved as First Drug for Agitation Related to Dementia in Adults with Alzheimer’s Disease
The FDA approved Rexulti (brexpiprazole) for Alzheimer’s-related agitation based on the findings of two clinical trials.
New Fabry Disease Treatment Enters Lucrative Market
A wholesale acquisition cost (WAC) for Elfabrio will be announced once it is available in a few weeks.
Rollercoaster of Hospital COVID Drug Spending Continued in 2022
Using a national database, data on medication purchases was collected, along with factors that may have influenced expenditures, such as new therapy availability, patent expirations, policy changes, and legislation.
FDA Okays First-in-Class Eye Spray
Treatment will benefit millions”of patients, says Eyenovia, the company that developed the product.
GSK’s Arexvy is First RSV Vaccine Approved for Older Adults
In June, the Advisory Committee on Immunization Practices (ACIP) will make recommendations on the appropriate use of the vaccine in the U.S.
Two FDA Approvals for Expanded Pediatric Indications
Cystic fibrosis drug Trikafta gets expanded indication for children ages 2-5.
Avadel Says New Narcolepsy Med Will be Priced Competitively
Despite having a highly differentiated clinical value proposition compared to branded, twice-nightly oxybates, Avadel is pricing Lumryz at $64.67 per gram or around $177,034 annually, which is on par with twice-nightly oxybate products that require chronic, middle-of-the-night awakening.
FDA Approves First Fecal Microbiota Pill for Recurrent C. diff Infection
CDI is a leading cause of infections acquired in healthcare settings, including hospitals and nursing homes. After recovering, individuals may get the infection again, and the risk of recurrence increases with each infection.
FDA OKs First-of-its-Kind Treatment for Rare Form of ALS
The list price for Qalsody, the first and only approved treatment to target a genetic cause of ALS, may prove to be controversial.
Hospital Group Assails AHIP’s Drug Price Report
The American Hospital Association said the health insurers' report on drug prices, which highlights the higher prices charged by hospitals, is “a blatant attempt to deflect from the obvious — insurance companies continue to raise premiums for their enrollees and employer clients while pocketing billions in profit.”
AbbVie Snags New Chronic Migraine Indication for Qulipta
Qulipta (atogepant) produced $158 million last year in net revenues in the U.S. as a preventive agent for episodic migraines.
FDA Requires New Warnings For Prescription Opioids in Another Step to Prevent Overdoses
One of the warnings regard the risk of opioid-induced hyperalgesia, a condition associated with taking opioids that causes an increase in pain or an increased sensitivity to pain.
Express Scripts Expands Independent Pharmacy in Rural Healthcare
The expansion offers increased reimbursement opportunities and additional care services to rural independent pharmacies. In addition, it creates an Independent Pharmacy Advisory Committee to expand the role of rural, suburban and urban pharmacies in the healthcare system.
FDA Approves Omisirge to Reduce Infection Risk in Blood Cancer Patients Undergoing Stem Cell Transplant
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
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.
HyQvia Receives Expanded FDA Approval for Pediatric Primary Immunodeficiency
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
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
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?
Healthcare Groups, Legislators Slam Texas Mifepristone Ruling
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
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
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
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?
A study funded by Genentech showed that the assistance programs substantially reduce prescription abandonment regardless of race or income level.
Amazon to Offer Pharma Company Coupons on Branded Drugs
The new feature automatically applies manufacturer-sponsored coupons directly to an eligible patient’s order. So far, just a few pharma companies have made their coupons available through Amazon.
New Insulin Cap Bill Lauded, But Caution Urged
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
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
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
If approved, Perrigo’s Opill could be the first-ever nonprescription birth control pill.
FDA Approves First Treatment for Rare Immunodeficiency Disease
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
Rezzayo is a novel once-weekly antifungal approved to treat invasive candidiasis, a serious infection that can affect the blood, heart and brain.
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