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Life Sciences › Drug Pricing › Regulatory Oversight

Husch Blackwell LLP

FDA Launches Commissioner’s National Priority Voucher Program: What Life Sciences Innovators Need to Know

Husch Blackwell LLP on

On June 17, 2025, the Food and Drug Administration (FDA) announced the Commissioner’s National Priority Voucher (CNPV) program, a bold initiative designed to accelerate the review of therapies addressing critical national...more

Jones Day

Tillis Urges FDA, USPTO to Investigate Potential False Narrative by Drug Critics

Jones Day on

On January 31, 2022, Sen. Thom Tillis (R-N.C.), the Ranking Member of the Senate Judiciary Committee Subcommittee on Intellectual Property, sent a letter to Janet Woodcock, Acting Commissioner of the FDA, and Drew...more

Hogan Lovells

Spain agrees to new economic regime for orphan medicinal products

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On 3 March 2020, the Spanish Council of Ministers, based on Article 3(3) of the Spanish Regulation on Medicinal Products (RDL 1/2015), agreed on a new economic regime for orphan medicinal products. ...more

McDermott Will & Schulte

Special Report: FDA 2019 Year in Review

McDermott Will & Schulte on

The US Food and Drug Administration’s (FDA’s) 2019 regulatory agenda focused on digital health, streamlined product approvals, evolving evidentiary thresholds for product approvals and strategic enforcement. The agency...more

Hogan Lovells

China: Survival of the Fittest or Cheapest?

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The past year is set to be a milestone year for China’s pharmaceutical regulatory reform as the newly formed National Medical Products Administration (NMPA) continues to aggressively cut back on red tape for new drug...more

Hogan Lovells

U.S. Senate passes bill requiring prescription drug ads to include prices

Hogan Lovells on

On Thursday, the U.S. Senate passed (85-7) the fiscal year 2019 minibus appropriations bill (H.R.6157) that would fund the Departments of Labor, Health and Human Services (HHS), and Education, attaching to it a large...more

Hogan Lovells

The South African pharmaceutical regulatory environment

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Our local pharmaceutical environment is highly regulated.The most important legislative provisions are found in the Medicines Act and the Pharmacy Act....more

Akerman LLP - Health Law Rx

Derailing the Gravy Train – Trump Unveils Plan to Reduce Drug Prices

Akerman LLP - Health Law Rx on

Throughout his presidential campaign, President Trump championed the need to allow the government to negotiate drug prices on behalf of the Medicare program. However, that third rail for pharmaceutical companies was not...more

Hogan Lovells

Administration presents plans to lower drug prices

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On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices. ...more

Hogan Lovells

Life Sciences and Health Care Horizons - 2018

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Innovation in the life sciences and health care industries is occurring at a dizzying pace. Five years ago, anti-PD-1 antibodies from Merck and BMS had yet to be approved, CAR-T therapies were still in small-scale clinical...more

Hogan Lovells

Excessive pricing in pharmaceutical products attracts the European Commission's attention

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In recent years competition authorities in a number of EU Member States have stepped up in their pursuit against companies active in the Life Sciences sector for excessive pricing. Last week, the European Commission issued a...more

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