STAT

JANUARY 5, 2024

Flovent’s manufacturer, GSK, has discontinued both versions of the product — Flovent HFA, an inhalation aerosol, and Flovent Diskus, an inhalation powder — and replaced each with what is known as an “ authorized generic ,” essentially the same product sold under a private label. Prasco, a U.S.

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Pharmaceutical Technology

AUGUST 30, 2024

US Congress labelled pharmacy benefit managers (PBMs) as ‘anticompetitive’; PBMs blame manufacturers for increasing pharmaceutical prices.

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Pharmaceutical Commerce

FEBRUARY 22, 2024

A cohort study investigates how a change in clinical guidelines, an expanded label, and reduction in drug prices can impact the use of PCSK9 inhibitors as a treatment for atherosclerotic cardiovascular disease.

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Drug Pricing Labelling 104

STAT

SEPTEMBER 13, 2024

They didn’t get any money for the drugs, which is paid to pharmacies. One doctor said he thinks the company wants to discourage using the drugs for unapproved purposes, a practice called off-label prescribing, which is legal and accepted in American medicine.

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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.

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Labelling Drug Pricing 52

FDA Law Blog: Biosimilars

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list. In the second category—limiting blockades to marketing—are efforts to limit blocking exclusivities and induced infringement liability.

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Labelling Biosimilars Drug Pricing Dosage 104

Safe Biologics

DECEMBER 3, 2023

The most recen t of the webinars, hosted July 29th, examined the negative impact of the Inflation Reducation Act’s Medicare drug price setting provisions. The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars.

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Drug Channels

MARCH 4, 2025

Emerging controversies, challenges, and threats to watch in the industry And much more!

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Drug Channels

OCTOBER 3, 2023

CVS Health launched Cordavis, a new subsidiary that will market a private label, low-list-price version of Sandoz’ Hyrimoz. Surprisingly, two PBMs—Express Scripts and OptumRx—will each offer at least one low-list-price biosimilar option on their main national formularies. The Humira biosimilar market has arrived!

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Biosimilars Drug Pricing Labelling 98

FDA Law Blog: Biosimilars

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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Putting Patients First Blog

SEPTEMBER 3, 2024

Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drug price negotiations.

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Safe Biologics

NOVEMBER 12, 2023

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.

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Biosimilars Drug Pricing Packaging Labelling 130

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

The manufacturer’s agreement must cover all its labeler codes that contain an applicable drug or a selected drug. All labeler codes that are covered by Discount Program agreements will be distributed to PDP sponsors and posted on the CMS website. of the total expenditures for all Part D drugs in 2021.

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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.

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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.

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Express Pharma

OCTOBER 2, 2024

Rating the 1QFY25 performance of a sample of 18 leading pharma companies, the Ind-Ra report points out that normalisation of drug prices in the US and a softening in raw material prices will help companies to keep revenue growth of 9 per cent yoy and EBITDA margin of about 22 per cent during FY25.

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Drug Pricing Documentation Labelling 105

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.

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Biosimilars Packaging Labelling Drug Development 130

Big Molecule Watch

JANUARY 25, 2024

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. Recommendations regarding how to describe pediatric use data in a range of scenarios and how to incorporate immunogenicity data.

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Biosimilars Labelling Drug Pricing 45

Big Molecule Watch

JANUARY 10, 2025

pharmacies in 2023, and with the PBMs operating in a system from the drug private labeler all the way down to the pharmacy and health insurer. Amgens BKEMV (eculizumab-aeeb) was approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PHN) or atypical hemolytic uremic syndrome (aHUS).

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Biosimilars Drug Pricing Labelling Communication 45

FDA Law Blog: Biosimilars

JUNE 2, 2023

Absent from the statute is any requirement to report information on manufacturer costs and price setting. Nevertheless, riding on the wave of drug price transparency legislation in several states and similar legislative proposals in Congress, CMS is proposing to expand the MDRP into the realm of drug price transparency reporting.

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pharmaphorum

JUNE 24, 2021

If its assumptions are wrong, “we stand ready to work with public and private payers to address pricing in order to achieve both patient access and support budget sustainability,” said the companies.

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Labelling Drug Pricing 78

pharmaphorum

JUNE 8, 2021

ICER argues that Aduhelm was effectively approved on the strength of a biomarker – removing amyloid from the brain – rather than clinical outcomes, which is “puzzling” as other drugs have been shown to remove amyloid from the brain yet failed to help patients. Broad label questioned.

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Labelling Drug Pricing 98

Proxsys Rx

DECEMBER 11, 2023

However, the level of reimbursement they receive is dependent on the proven efficacy of their drugs — and many of their most expensive specialty drugs are manufactured under what might be labeled as “pseudo-approved” status.

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Specialty Pharmacies Hospitals Drug Pricing Labelling 52

Proxsys Rx

MARCH 1, 2024

However, the level of reimbursement they receive is dependent on the proven efficacy of their drugs — and many of their most expensive specialty drugs are manufactured under what might be labeled as “pseudo-approved” status.

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Specialty Pharmacies Hospitals Drug Pricing Labelling 40

STAT

MARCH 4, 2024

judge in Delaware ruled against AstraZeneca on all its major arguments in a case challenging the constitutionality of Medicare’s new drug price negotiation program , STAT reports.  For more than 20 years, FDA labeling limited dispensing to a subset of specialty offices and clinics over safety concerns.

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Drug Pricing Labelling 262

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. Issue Brief: Improving Prescription Drug Price and Cost Transparency. 2 (2024): 206 214, [link] www.jmcp.org/doi/epdf/10.18553/jmcp.2024.30.2.206.

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Insurance Coverage and Processing Biosimilars Communication Department of Veterans Affairs 40

Safe Biologics

APRIL 10, 2023

CMS Releases Guidance Memo on Medicare Drug Price Negotiation; Allows Only 30 Days to Comment On March 15, 2023, the Centers for Medicare and Medicaid (CMS) released an initial Guidance Memo regarding implementation of its Medicare Drug Price Negotiation Program, authorized by the Inflation Reduction Act (IRA) signed into law August 16, 2022.

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Biosimilars Drug Pricing Diabetes Labelling 130

pharmaphorum

NOVEMBER 27, 2020

The new EU approval comes after the FDA approved the expanded label last year, and provides the first treatment option that tackles the underlying cause of CF in patients aged six to 11 with these mutations.

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Labelling Drug Pricing 134

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.

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Biosimilars Drug Pricing Documentation Labelling 130

Pharmaceutical Technology

JANUARY 5, 2023

The survey results also indicated that drug pricing and reimbursement constraints will be the second biggest concern, hampering the industry’s growth, as indicated by 30% of the surveyed respondents. To adapt is the only way to thrive. The pharmaceutical sector will need to find new ways to offset regulatory and inflationary pressures.

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Drug Pricing Vaccines Labelling Communication 69

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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STAT

FEBRUARY 24, 2025

In a lawsuit filed in a federal court in New Jersey on Monday, J&J argued that Samsung Bioepis improperly reached an agreement to supply an unnamed health care conglomerate with a private label biosimilar version of Stelara, which has been widely prescribed for years to treat various inflammatory skin and bowel conditions.

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Express Pharma

FEBRUARY 10, 2025

We’re really having the ability now in a much more regulated framework and environment about what we can say in the pharma industry has to be on label. We do quite a lot of work in what we call the value and access space, related to value propositions, engaging healthcare systems, drug pricing, drug access.

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Pharmaceutical Technology

MAY 24, 2023

The US Department of Health and Human Services (HHS) and the Centers for Medicare & Medicaid Services (CMS) have announced steps to push down prescription drug prices under Medicaid as part of a new proposal. It specifically seeks to improve the Medicaid Drug Rebate Program (MDRP).

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STAT

AUGUST 23, 2024

The four-day Chicago event projected a reenergized party charged to fight for reproductive rights, low drug costs, health care freedom — and a healthier state of mind. Former President Bill Clinton labeled Harris “the president of joy.”

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Labelling Drug Pricing 342

STAT

NOVEMBER 11, 2024

Plus, we note that GLP-1 drugs can increase a person’s risk of aspiration when undergoing surgery. This story first appeared in The Readout newsletter.    Sign up for The Readout  and receive STAT’s award-winning biotech news delivered straight to your inbox.    Good morning!

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Labelling Drug Pricing Drug Development 284

Drug Channels

NOVEMBER 12, 2024

Fein will share his latest thinking and projections on a wide range of topics, including: Latest predictions for the Inflation Reduction Act Expectations for the Medicare Part D market in 2025 and beyond Update on 340B Drug Pricing Program’s controversies Impact of the new Trump administration and Congress on the drug channel Vertical integration and (..)

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Drug Pricing Biosimilars Labelling 98