PS-MarketAccess (Premium-2): Why Financial Scammers Are So Successful Targeting Doctors

 
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Doctors are increasingly falling victim to financial scams due to their high incomes, busy schedules, and trust in professional networks. Recognizing the tactics scammers use and the reasons behind physicians’ susceptibility is essential for protecting medical professionals.

Gene Therapy Hemgenix Gains Ground In Europe With Spanish Reimbursement Deal

 
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Hemgenix has now secured reimbursement in several European markets, and while the path to reimbursement for the high-cost product has not always been easy, innovative access deals have helped to smooth the way.

CMS Should ‘Clarify’ That Part B Inflation Rebates Do Not Apply In Medicare Advantage, Pharma Urges

 
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The Centers for Medicare and Medicaid Services is considering imposing price inflation rebates on Part B drugs furnished to enrollees in Medicare Advantage plans in addition to those covered by fee-for-service Medicare.

Senate Hearing On Ozempic, Wegovy Highlights Concerns About PBMs, International Price Disparities

 
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Senate HELP Committee chair Sanders trying to broker a deal between Novo Nordisk and the major pharmacy benefit managers that will lead to lower list prices.


Shot Across The Bow? Express Scripts Lawsuit Seeks To Derail Fall-Out From FTC PBM Report

 
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Pharmacy benefit manager sues Federal Trade Commission claiming chair Khan has orchestrated a campaign against PBMs that is not based in fact.

‘Alternative' PBMs Say Vertical Integration Unfairly Carving Them Out Of The Game

 

Alternatives to the top pharmacy benefits managers argue health plan-PBM integration is leading to anti-competitive tactics that make it impossible for some employers to switch PBMs.

UK MHRA First-Half New Drug Approvals Show Overwhelming Use Of EU Reliance Procedures

 
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The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.

HTA Regulation: EU Publishes Guidance On Validity Of Clinical Studies For Joint Clinical Assessments

 

Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.


US FDA Biologics Designation As Price Protection: Lilly Charts New Course With Retatrutide

 
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An effort to change the US Food and Drug Administration’s conclusion that its obesity treatment candidate retatrutide is a drug and not a biologic could give the product more time with unrestricted pricing in Medicare, among other benefits.

Australia Considers New 'Bridging Fund' Among 50 Recommendations For HTA Reform

 

Industry says it is ready to work with the government on the recommendations from a major review of Australia’s health technology assessment system that covers areas such as discount rate reductions and setting up a separate budgetary allocation to temporarily subsidize access to certain drugs.

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FDA’s Marks Issues ‘Provocative’ Call To Set Target Gene Therapy Profile That Includes Costs

 

CBER Director Peter Marks said recent leaps in gene therapy science have not been matched by more affordable manufacturing technology and that there is a need to set a cost-effectiveness target for the field.


PBM Legislation: Medicare Rebate Reform May Be Challenging Amid Disruption From Redesign

 
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US lawmakers will undoubtedly continue to work on pharmacy benefit manager reform legislation in 2025, given its bipartisan support. But policies impacting rebates that could lead to higher premiums in Part D may be a tough sell in the midst of the benefit redesign.

PBM Rebating Practices: How Much Do Employer Plan Sponsors Really Know?

 
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A National Pharmaceutical Council survey of self-insured employers offers a new perspective on pharmacy benefit manager claims that rebating practices only reflect the decisions made by their clients.

Overcoming The Challenges Of Developing Hearing Loss Therapies

 
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Finding the right way to measure outcomes is just one of the difficulties involved in conducting clinical trials of potential new therapies for loss of hearing, which can have a number of different causes.

HRSA-J&J Dispute Over 340B Rebate Plan Again Underscores Need For Program Reform

 
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Johnson & Johnson plans to shift 340B price concessions on Stelara and Xarelto to rebates for some hospitals beginning in October, allowing for more company oversight of claims.


MSN Generic Entresto Launch In Doubt After US Appeals Court Stops Approval

 
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MSN Laboratories will be unable to move forward with any potential ‘at-risk’ launch for its generic version of Novartis’ Entresto blockbuster in the US for now after the originator won a stay of the firm’s ANDA approval pending appeal from the US Court of Appeals for the District of Columbia Circuit.

Responsible Antimicrobial Manufacturing A Must For UK’s Subscription Model Applicants

 

The UK will require all antibiotic manufacturers looking to apply for funding under its subscription payment model to demonstrate they are meeting waste discharge standards in a bid to reduce antimicrobial resistance.

US Presidential Elections: Are Prescription Drug Pricing Reforms Losing Political Luster?

 
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Neither Kamala Harris nor Donald Trump mentioned drug pricing reforms in their presidential convention speeches.

Accelerated Approvals In Medicare: CED Guidance Notes Ongoing Concern With Surrogate Endpoints

 
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Medicare coverage with evidence development final guidance includes few substantive changes from the proposed version despite biopharma stakeholder concerns.