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FDA Accepts BLA for Lifileucel for Difficult-to-Treat Melanoma
FDA Accepts BLA for Lifileucel for Difficult-to-Treat Melanoma
FDA Accepts BLA for Lifileucel for Difficult-to-Treat Melanoma
May 31, 2023
Lifileucel is a polyclonal tumor infiltrating lymphocyte (TIL) therapy designed for patients with advanced melanoma who have experienced progression after previous treatment with anti-PD-1/L1 therapy and targeted therapy.
  New Heart Failure Med Will be Priced 'Competitively'
  New Heart Failure Med Will be Priced 'Competitively'
New Heart Failure Med Will be Priced 'Competitively'
May 30, 2023
Inpefa (sotagliflozin) is in the SGLT inhibitor class recommended as first-line treatment for heart failure by the American Heart Association and other groups. Jardiance (empaglifozin), a competitor in that class, has a list price of $570.48 for a month's supply.
Drug Manufacturer Coupons: Marketing Tools Perceived as Charitable Assistance
Drug Manufacturer Coupons: Marketing Tools Perceived as Charitable Assistance
Drug Manufacturer Coupons: Marketing Tools Perceived as Charitable Assistance
May 26, 2023
The frequency of drug manufacturer coupon utilization is associated with more market competition—but not patients’ out-of-pocket costs.
FDA Clears Paxlovid as First Oral Antiviral for COVID-19
FDA Clears Paxlovid as First Oral Antiviral for COVID-19
FDA Clears Paxlovid as First Oral Antiviral for COVID-19
May 25, 2023
More than 11.6 million treatment courses of the medication have been prescribed in the U.S. to date.
  Unique New Lymphoma Treatment Priced at $37,500 Monthly
  Unique New Lymphoma Treatment Priced at $37,500 Monthly
Unique New Lymphoma Treatment Priced at $37,500 Monthly
May 24, 2023
AbbVie and Genmab have set a price for newly approved Epkinly (epcoritamab-bysp).
FDA Approves New Treatments for Opioid Overdose, Opioid Use Disorder
FDA Approves New Treatments for Opioid Overdose, Opioid Use Disorder
FDA Approves New Treatments for Opioid Overdose, Opioid Use Disorder
May 24, 2023
The FDA recently approved Brixadi to treat moderate to severe opioid use disorder in patients who have already started treatment with a transmucosal form of buprenorphine, and have approved Opvee as an emergency treatment to reverse known or suspected opioid overdose in people ages 12 years and older.
First Interchangeable Biosimilar to Humira Gets Approval for Pen Form
First Interchangeable Biosimilar to Humira Gets Approval for Pen Form
First Interchangeable Biosimilar to Humira Gets Approval for Pen Form
May 22, 2023
The Cyltezo Pen is scheduled to be on the market and available on July 1.
FDA OKs First Oral Drug for Crohn’s Disease
FDA OKs First Oral Drug for Crohn’s Disease
FDA OKs First Oral Drug for Crohn’s Disease
May 19, 2023
The list price for a 30-day supply of the drug, Rinvoq, is around $6,125. Eligible patients may be able to benefit from copay savings cards and other financial support programs from AbbVie.
FTC Targets Two GPOs in PBM Investigation
FTC Targets Two GPOs in PBM Investigation
FTC Targets Two GPOs in PBM Investigation
May 18, 2023
The compulsory orders will require the GPOs, which negotiate drug rebates on behalf of other PBMs, to provide information and records on their business practices.
Specialty Drugs: Higher Patient Cost Sharing and Prior Auths Linked to Abandoned Meds, Treatment Delays
Specialty Drugs: Higher Patient Cost Sharing and Prior Auths Linked to Abandoned Meds, Treatment Delays
Specialty Drugs: Higher Patient Cost Sharing and Prior Auths Linked to Abandoned Meds, Treatment Delays
May 17, 2023
But higher costs for cancer drugs did not influence some common measures of adherence, such as medication possession ratio and proportion of days. The researchers believe that cancer patients may be more likely to adhere to medication regimen, regardless of price, because the drugs are critical for survival.
Dual Steroid Treatment Adds Benefit in Septic Shock, Study Finds
Dual Steroid Treatment Adds Benefit in Septic Shock, Study Finds
Dual Steroid Treatment Adds Benefit in Septic Shock, Study Finds
May 17, 2023
Researchers found a significant decrease in mortality or discharge to hospice with the hydrocortisone-fludrocortisone combination versus hydrocortisone alone in septic shock cases.
FDA Fast Tracks CAR-T Lymphoma Med, Atrial Fibrillation Treatment
FDA Fast Tracks CAR-T Lymphoma Med, Atrial Fibrillation Treatment
FDA Fast Tracks CAR-T Lymphoma Med, Atrial Fibrillation Treatment
May 16, 2023
The atrial fibrillation drug, asundexian, may provide protection from thrombotic events without a corresponding increase in bleeding risk.
PBMs Face New Criticism From Old and New Foes
PBMs Face New Criticism From Old and New Foes
PBMs Face New Criticism From Old and New Foes
May 16, 2023
The National Community Pharmacists Association now has plenty of allies in its fight with the pharmacy benefit managers.
Brexpiprazole Approved as First Drug for Agitation Related to Dementia in Adults with Alzheimer’s Disease
Brexpiprazole Approved as First Drug for Agitation Related to Dementia in Adults with Alzheimer’s Disease
Brexpiprazole Approved as First Drug for Agitation Related to Dementia in Adults with Alzheimer’s Disease
May 12, 2023
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
New Fabry Disease Treatment Enters Lucrative Market
New Fabry Disease Treatment Enters Lucrative Market
May 11, 2023
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
Rollercoaster of Hospital COVID Drug Spending Continued in 2022
Rollercoaster of Hospital COVID Drug Spending Continued in 2022
May 10, 2023
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
FDA Okays First-in-Class Eye Spray
FDA Okays First-in-Class Eye Spray
May 10, 2023
Treatment will benefit millions”of patients, says Eyenovia, the company that developed the product.
Analyzing Cost-effectiveness Thresholds Over Time
Analyzing Cost-effectiveness Thresholds Over Time
Analyzing Cost-effectiveness Thresholds Over Time
May 5, 2023
Cancer-related cost-effective analyses (CEA) referenced higher thresholds than non-cancer-related CEAs, which may suggest interventions for diseases associated with greater mortality and morbidity warrant higher thresholds.
GSK’s Arexvy is First RSV Vaccine Approved for Older Adults
GSK’s Arexvy is First RSV Vaccine Approved for Older Adults
GSK’s Arexvy is First RSV Vaccine Approved for Older Adults
May 4, 2023
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
Two FDA Approvals for Expanded Pediatric Indications
Two FDA Approvals for Expanded Pediatric Indications
May 3, 2023
Cystic fibrosis drug Trikafta gets expanded indication for children ages 2-5.
Avadel Says New Narcolepsy Med Will be Priced Competitively
Avadel Says New Narcolepsy Med Will be Priced Competitively
Avadel Says New Narcolepsy Med Will be Priced Competitively
May 2, 2023
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.
Patients Often Lose in the Battle between Pharma and PBMs
Patients Often Lose in the Battle between Pharma and PBMs
Patients Often Lose in the Battle between Pharma and PBMs
May 2, 2023
Over the last five years, both PBMs and drug manufacturers have implemented restrictions that put more of the costs for specialty medications on patients.
FDA Clears Two Schizophrenia Meds
FDA Clears Two Schizophrenia Meds
FDA Clears Two Schizophrenia Meds
May 1, 2023
Uzedy’s wholesale acquisition cost (WAC) ranges from $1,232 to $3,080 per month.
FDA Approves First Fecal Microbiota Pill for Recurrent C. diff Infection
FDA Approves First Fecal Microbiota Pill for Recurrent C. diff Infection
FDA Approves First Fecal Microbiota Pill for Recurrent C. diff Infection
April 28, 2023
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
FDA OKs First-of-its-Kind Treatment for Rare Form of ALS
FDA OKs First-of-its-Kind Treatment for Rare Form of ALS
April 27, 2023
The list price for Qalsody, the first and only approved treatment to target a genetic cause of ALS, may prove to be controversial.
54% of Top-Selling Medicare Drugs Rated as Low-Benefit, Study Finds
54% of Top-Selling Medicare Drugs Rated as Low-Benefit, Study Finds
54% of Top-Selling Medicare Drugs Rated as Low-Benefit, Study Finds
April 26, 2023
The study found that Medicare patients used low-benefit options more frequently than high-benefit options.
Hospital Group Assails AHIP’s Drug Price Report
Hospital Group Assails AHIP’s Drug Price Report
Hospital Group Assails AHIP’s Drug Price Report
April 25, 2023
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
AbbVie Snags New Chronic Migraine Indication for Qulipta
AbbVie Snags New Chronic Migraine Indication for Qulipta
April 24, 2023
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
FDA Requires New Warnings For Prescription Opioids in Another Step to Prevent Overdoses
FDA Requires New Warnings For Prescription Opioids in Another Step to Prevent Overdoses
April 21, 2023
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
Express Scripts Expands Independent Pharmacy in Rural Healthcare
Express Scripts Expands Independent Pharmacy in Rural Healthcare
April 20, 2023
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.
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