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

Big Molecule Watch

AUGUST 25, 2023

The Inflation Reduction Act’s Medicare Drug Price Negotiation Program will kick off next week. There are reports that the White House may announce the list of selected drugs even before that deadline, on Tuesday, August 29 th. Before the IRA, the government could not set prices for any drugs covered by Medicare.

Drug Pricing 40

Drug Pricing Biosimilars Insurance Coverage and Processing Labelling 40

Big Molecule Watch

JANUARY 25, 2024

As we kick off 2024, we reflect on regulatory developments in the biologics and biosimilars space in 2023. The licensure and marketing of WEZLANA could affect negotiations with CMS regarding Medicare pricing for STELARA under the Inflation Reduction Act’s Drug Price Negotiation Program.

Biosimilars 45

Biosimilars Labelling Drug Pricing 45

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.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

Putting Patients First Blog

JANUARY 27, 2025

3 ,4, 5 As such, the NHC supports CMS proposal to ensure that Part D sponsors cover AOMs for obesity with clinical criteria that is not more restrictive than the FDA labeling for each AOM. 19 National Health Council, National Health Council 2024 Public Policy Issue Areas Survey (internal survey, Policy & Government Affairs, 2023).

Insurance Coverage and Processing 40

Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

Labelling 105

Labelling Drug Pricing Compounding Payment Processing 105

Pharmaceutical Technology

JUNE 30, 2025

The agency said that safety information can be adequately conveyed using drug product labelling. How will RFK Jr’s American dream for vaccines play out? This includes a boxed warning for the risks of CRS and neurological toxicities.

Insurance Coverage and Processing 52

Insurance Coverage and Processing Packaging Labelling Communication 52

Safe Biologics

MAY 10, 2024

View ASBM’s educational fact sheet “Interchangeability: US vs EU” here. Biden’s SOTU: 500 Drugs To Be Subject to Medicare Drug Price Controls On March 7th, President Biden gave his State of the Union address to Congress, wherein he laid out upcoming policy priorities for a potential second term.

Biosimilars 130

Biosimilars Drug Pricing Documentation Labelling 130

BioPharma Dive

JUNE 27, 2025

Specifically, it removes so-called “Risk Evaluation and Mitigation Strategies” from the drugs’ labeling, which are used to help manage serious side effects of treatment. You can unsubscribe at anytime. Recent biotech company acquisitions have put emerging schizophrenia treatments in focus. Registered in England and Wales.

Drug Pricing 55

Drug Pricing Hospitals Immunization Immunity 55

Pharmaceutical Technology

JUNE 30, 2025

of equity shares from JB employees at the same price per share as offered to KKR. of equity shares from JB employees at the same price per share as offered to KKR. How will RFK Jr’s American dream for vaccines play out?

Packaging 52

Packaging Communication Hospitals Drug Pricing 52

Pharmaceutical Technology

JUNE 30, 2025

How will RFK Jr’s American dream for vaccines play out?

Packaging 52

Packaging Hospitals Compounding Communication 52

Pharmaceutical Technology

JUNE 30, 2025

How will RFK Jr’s American dream for vaccines play out?

Packaging 71

Packaging Communication Hospitals Vaccines 71

Pharmaceutical Technology

JUNE 6, 2025

Originally approved for children in 2021, the FDA updated the drug’s label in January this year to include adults. The mechanism of action of Qelbree, though unclear, is thought to be through inhibiting the reuptake of norepinephrine. ADHD treatments were in the political crosshairs in the US recently.

Communication 52

Communication Hospitals Drug Pricing Packaging 52

Express Pharma

FEBRUARY 10, 2025

What are the top 3 biopharma trends that you have observed in 2024 with India as a focused region as well as looking at it locally? Global trends: The emphasis on technology, AI, and generative AI is very strong within the biopharma sector, spanning areas like drug discovery, development, commercialisation, and the supply chain.

Documentation 100

Documentation Drug Pricing Labelling Biosimilars 100

BioPharma Dive

JUNE 5, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from FDA’s AI tool ‘Elsa’ is here, and the industry has questions The agency has provided only limited details about its AI pilot as it advances an “aggressive timeline” for the tool’s rollout.

Drug Pricing 52

Drug Pricing Drug Development Vaccines Pharmaceutical Manufacturing 52

Pharmaceutical Technology

JUNE 30, 2025

However, both tariffs still apply to many upstream components and materials used in pharmaceutical production, which is already leading to supply chain disruptions and potentially contributing to higher drug prices in the future as manufacturers look to pass on the increased expenses to payers.

Health and Personal Care Stores 52

Health and Personal Care Stores Packaging Drug Pricing Pharmaceutical Manufacturing 52

BioPharma Dive

JUNE 11, 2025

And though Roche and Bristol Myers acquired both their medicines in high-priced acquisitions, they haven’t yielded significant sales: Rozlytrek generated about 134 million Swiss francs in 2024 , while Augtyro pulled in just $38 million. You can unsubscribe at anytime. Informa PLCs registered office is 5 Howick Place, London SW1P 1WG.

Drug Pricing 113

Drug Pricing Immunization Immunity Drug Development 113

Drug Channels

NOVEMBER 12, 2024

president of Drug Channels Institute (DCI) and the author of Drug Channels , invites you to join him for DCI’s new live video webinar: Drug Channels Outlook 2025 This event will be broadcast live on Friday, December 13, 2024, from 12:00 p.m. This event is part of The Drug Channels 2024 Video Webinar Series.

Drug Pricing 98

Drug Pricing Labelling Biosimilars 98