FDA Law Blog: Biosimilars

APRIL 16, 2024

Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. NDA or BLA drugs). Vanda Pharmaceuticals, Inc. Centers for Medicare and Medicaid Servs., 23-1457 (4th Cir.

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Dosage Drug Pricing Pharmaceutical Manufacturing 59

Pharmaceutical Technology

JANUARY 6, 2023

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. These actions allegedly led to the extension of Novartis’ patents.

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Documentation Hospitals Dosage Drug Pricing 97

Pharmaceutical Technology

MAY 29, 2008

Important elements within this expectation are the build up of strong contributions from Rotarix, Cervarix and Tykerb, while the outlook for GSK’s important asthma franchise becomes less clear beyond 2010. PT: Glaxo shares have fallen 17% in the past year.

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Drug Pricing Diabetes Drug Development 40

NY Times

JULY 6, 2022

The drug-pricing plan was negotiated with Senator Joe Manchin III of West Virginia, but Democrats remain short of agreement on what else would be included in any domestic policy package.

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Drug Pricing Packaging 66

STAT

AUGUST 30, 2024

The Biden administration recently announced that it will use taxpayer dollars to “ stabilize ” Medicare Part D (prescription drug coverage) premiums. These premiums had been remarkably stable since 2010, growing slower than inflation. But in 2025, they are expected to nearly triple.

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Drug Pricing 318

pharmaphorum

SEPTEMBER 8, 2020

4 Global oncology spending in 2010, 2015, and 2020, by region (in billion U.S. 6 Forbes, ‘Biologic Medicines: The Biggest Driver of Rising Drug Prices’. Available from : [link] [Last accessed: September 2020]. 3 Wilking N, Lopes G, Meier K, et al. Can we continue to afford access to cancer treatment? Touch Oncology.

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Biosimilars Drug Pricing Chemotherapy Vaccines 99

European Pharmaceutical Review

DECEMBER 26, 2023

Available from: [link] About the author Kai Lipinski, PhD joined Vibalogics, now ReciBioPharm, in 2010 as Head of Cell Culture and Virus Production. Production cost is currently a fundamental concern for many gene therapy developers, particularly given that some treatments cost millions of dollars per single dose (eg, $3.5

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Drug Pricing Packaging Vaccines Drug Development 98

Pharmaceutical Technology

JULY 21, 2022

According to the World Health Organization (WHO), two billion people lack access to essential or basic drugs. In 2010, only eight big pharma companies had an access strategy for low- and middle-income countries, but today, 17 of the biggest 20 companies do. Drug pricing and gouging.

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Drug Pricing Vaccines 52

Safe Biologics

SEPTEMBER 11, 2023

September 11, 2023 The Centers for Medicare & Medicaid Services (CMS) recently announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed in to law last year. 1] 90% of new cancer drugs are available in the U.S.

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Drug Pricing Biosimilars Vaccines Drug Development 150

STAT

OCTOBER 7, 2024

… Former President Trump is backing off his support for a controversial drug pricing plan that struck fear into the hearts of pharmaceutical executives during his first term , STAT reports. Meanwhile, we have assembled another menu of tidbits for you to peruse as you start another journey. Your cards and notes are appreciated.

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