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Pricing Debate

US NIH And Drug Pricing: Still Seeking A Balance

“Access Plans” are the US NIH’s new idea to address calls to take a more hands-on role in regulating the prices of products developed with taxpayer funding, but what the policy would actually mean for prices is hard to pin down, and that is probably deliberate.

Pricing Debate Legal Issues

Looming Step Therapy Ban In Illinois Is ‘Game Changer,’ Could Start Trend

Federal legislation on PBM reforms has stalled, but state efforts remain active. Illinois’ Healthcare Protection Act includes several other limits on insurer power, including prohibiting prior authorization for inpatient mental health care.

PBMs Reimbursement

Bipartisan House Support Remains Elusive In 340B Reform Effort

Republicans continue to take the lead on advancing reforms, while Democrats warn proposals could endanger a government program supporting safety-net care.

Pricing Debate Legislation

Quotable: Top Experts On Policy Hot Topics

The Pink Sheet highlights recent comments and insights from pharma officials and executives on key issues we are covering.

International Europe

BIO Notebook: Dealing With Rejection, Worrying About March-In Rights, And More

Insights from the first day of the international convention in San Diego also includes interviews on Alzheimer’s investments, dealmaking for mid-sized companies and reflections on the virtues of lean thinking.

BIO Deals

BIO Notebook: Dealing With Rejection, Worrying About March-In Rights, And More

Insights from the first day of the international convention in San Diego also includes interviews on Alzheimer’s investments, dealmaking for mid-sized companies and reflections on the virtues of lean thinking.

BIO Deals

House 340B Reform Bill Would Require Discount Pass Through, Define Patient, Hospital Eligibility

Legislation is the fruit of PhRMA’s lobbying collaboration with the National Association of Community Health Centers. It would also require manufacturers to supply contract pharmacies, within limits.

Pricing Debate Policy

Pink Sheet Podcast: Clinical Trial Reg Issues, NIH Drug ‘Access Plans’, Good Ole Days Of Woodcock

Pink Sheet editors discuss the US FDA’s potential regulatory changes to promote novel trial designs, an NIH proposal to better ensure access to a commercialized product, and lawmakers longing for Janet Woodcock's days running the Center for Drug Evaluation and Research.

Clinical Trials Pricing Debate

NIH Drug Patent Licensees Would Develop ‘Access Plan’ Under Proposal; Pricing Commitments Optional

Proposed rule would not require price concessions in the interest of balancing enhanced access with protecting the ‘viability and sustainability of a product’ in the market.

Policy Research & Development

Weight Loss, Diabetes Treatments Focus Of FTC's Second Round Of Patent Listing Challenges

The Pink Sheet takes a deep dive into the Federal Trade Commission's second wave of challenges to patents it asserts are improperly listed in the FDA's Orange Book, including patents covering Novo Nordisk's self-injection pens for Saxenda (liraglutide) and Ozempic (semaglutide).

Intellectual Property Pricing Debate

Former Sandoz Exec Kellum Avoids Jail Time Over US Price Fixing

Four years after pleading guilty plea generic price-fixing allegations, the former Sandoz US vice-president of business contracting and analytics, Hector Armando Kellum, will serve his sentence outside a jail cell and pay a fine.

Legal Issues Generic Drugs

The Looming US Election Weighs On The Minds Of Pharma

The November US presidential election could mean IRA expansion if President Biden wins, but a Trump victory brings uncertainty.

Politics Pricing Debate

The Looming US Election Weighs On The Minds Of Pharma

The US presidential election in November could mean IRA expansion from a Biden win, but a Trump victory also brings uncertainty.

Politics Policy

Patient Input In US Medicare Price Negotiation: Will CMS Close The Door?

The US Medicare agency is planning to modify its patient input process for feedback on products selected for price cuts in the program’s second year. The list of options includes holding the meetings in less public settings.

Medicare Pricing Debate

Are Managed Entry Agreements The Answer To EU Market Access For ATMPs?

EU-level action on market access could include a “solidarity fund” for ultra-rare disease treatments and a new framework for managed entry agreements.

Europe Gene Therapy

Hypertension To Mental Health Drugs: Indian Firms Supplied Bulk Of Rx Volume In US

Indian firms accounted for over 50% of prescription volumes in five of the top 10 therapy areas in the US in 2022, as also 15% of the volume share of biosimilars, delivering savings and widening patient coverage a study by IQVIA said, while also highlighting supply chain risks that need attention.

Commercial Generic Drugs
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