STAT

NOVEMBER 28, 2022

A hotly contested provision of a federal law designed to speed copycat drugs to market and foster competition saved Medicare $1.5 billion from 2015 to 2020 — or nearly 5% of the $30.2 billion spent by the health care program — on just five medicines during that period, according to a new analysis.

Labelling 257

Labelling Biosimilars Drug Pricing 257

pharmaphorum

JULY 15, 2022

Teva has asked the Supreme Court to look at a judgment in a $235 million patent dispute with GSK that it claims could undermine the ability of generic drugmakers to bring new products to market, and thereby help reduce drug prices. The substance patent expired in 2007.

Labelling 52

Labelling Drug Pricing 52

Putting Patients First Blog

JULY 2, 2024

General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare Drug Price Negotiation Program (DPNP). It is crucial to consider how off-label uses will be evaluated and incorporated into the negotiation process.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

Safe Biologics

DECEMBER 6, 2023

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. ASBM surveys of U.S.

Biosimilars 130

Biosimilars Packaging Labelling Drug Development 130

Pharmaceutical Technology

JANUARY 6, 2023

In 2020, the Federal Trade Commission issued a report regarding settlements reached between brand and generic manufacturers in FY 2017 and noted that “for the first time since [FY] 2004, no settlement agreement in [FY] 2017 contains a no-[authorized generic] AG commitment.”. These actions allegedly led to the extension of Novartis’ patents.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

Proxsys Rx

DECEMBER 11, 2023

At the same time, it’s no secret that, since the advent of 340B ESP in 2020, the drug manufacturers have imposed a raft of restrictions on 340B program savings that exist far outside the letter of the law as written by Congress in 1992.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Drug Pricing Labelling 52

Proxsys Rx

MARCH 1, 2024

At the same time, it’s no secret that, since the advent of 340B ESP in 2020, the drug manufacturers have imposed a raft of restrictions on 340B program savings that exist far outside the letter of the law as written by Congress in 1992.

Specialty Pharmacies 40

Specialty Pharmacies Hospitals Drug Pricing Labelling 40