STAT

JUNE 8, 2023

” FDA staff said that data from a late-stage trial of Eisai and Biogen’s Alzheimer’s drug suggests it offered a meaningful benefit to patients and safety concerns likely would not hamper its chances of a traditional approval , Reuters reports. The FDA decision is expected by July 6.

Drug Pricing 246

Drug Pricing Documentation 246

STAT

MAY 17, 2023

The Federal Trade Commission is widening its probe into pharmacy benefit managers and their impact on drug pricing by looking into a pair of group purchasing organizations that are owned by these industry middlemen, but are not well understood outside the industry.

Drug Pricing 254

Drug Pricing Documentation 254

STAT

SEPTEMBER 20, 2024

Also, we see more documents destroyed at an Indian drug manufacturing plant, and offer up a fabulous podcast.   Sign up  to get our biotech newsletter in your inbox. Good morning! Today, we see Ginkgo pivot into AI, becoming yet another contender in a crowded market. Read the rest…

Documentation 262

Documentation Drug Pricing Drug Development 262

STAT

FEBRUARY 2, 2024

WASHINGTON — A bipartisan group of senators released a draft of legislation to resolve controversial disputes in the 340B drug discount program, according to documents obtained by STAT.

Documentation 293

Documentation Drug Pricing 293

STAT

JULY 24, 2023

AbbVie, Teva Pharmaceutical, and AstraZeneca left over a span of five months following the passage of the drug-pricing reform law pushed by Democrats last year. Financial interests were often not clearly disclosed in NICE documents.

Drug Pricing 246

Drug Pricing Documentation 246

STAT

DECEMBER 29, 2022

Congressional investigators sorted through more than 500,000 pages of documents from the Food and Drug Administration and Biogen to chronicle how a controversial Alzheimer’s disease drug was approved, and how it went from what was supposed to be the biggest drug launch in history to a financial catastrophe.

Documentation 246

Documentation Drug Pricing 246

STAT

MAY 1, 2023

Senators drafting reforms to the drug middlemen industry have delayed their effective date by at least 10 months, according to new documents obtained by STAT. WASHINGTON — Pharmacy benefit managers may have gotten themselves a slight reprieve.

Documentation 246

Documentation Drug Pricing 246

STAT

DECEMBER 29, 2022

The downfall of Aduhelm, the first new treatment for Alzheimer’s disease in two decades, is largely the story of a drug company choosing to maximize its potential profits at the expense of patients and taxpayers, according to a congressional investigation that cites thousands of pages of internal Biogen documents.

Documentation 246

Documentation Drug Pricing 246

Pharmaceutical Commerce

JUNE 5, 2024

The courts reversed certain key guidance documents issued by the Health Resources and Services Administration for the 340B Program, which raises uncertainty.

Drug Pricing 81

Drug Pricing Documentation 81

RX Note

APRIL 16, 2023

Why Drug Prices Are Rising? Newly developed drugs can be expensive to produce. During patent exclusivity, prices are set higher to offset the high research and development cost (up to billions of dollars). Additionally, many middlemen are involved in the drug supply chain , each taking a cut of the profits.

Drug Pricing 40

Drug Pricing Documentation Pharmaceutical Companies Pharmaceutical Companies 40

Drug Channels

AUGUST 6, 2024

I then document how five multi-billion-dollar, for-profit, publicly traded pharmacy chains and pharmacy benefit managers (PBMs)—Cigna (via Express Scripts), CVS Health, UnitedHealth Group (via OptumRx), and Walgreens, Walmart—continue to dominate the 340B contract pharmacy market.

Drug Pricing 90

Drug Pricing Documentation Hospitals 90

Big Molecule Watch

OCTOBER 2, 2023

Ohio, Judge Newman) issued the first substantive order addressing legal challenges to the Drug Price Negotiation Program of the Inflation Reduction Act. New Complaint by Novo Nordisk Also on Friday, Novo filed a new Complaint challenging the Drug Price Negotiation Program and CMS’s actions in implementing it.

Drug Pricing 64

Drug Pricing Documentation 64

STAT

SEPTEMBER 29, 2022

WASHINGTON — New documents obtained by STAT outline how Medicare is planning to build out a sizable new bureaucratic infrastructure to handle its new power to negotiate drug prices and penalize drugmakers for price hikes.

Drug Pricing 262

Drug Pricing Documentation 262

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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Drug Pricing Biosimilars Dosage Documentation 45

Pharma in Brief

NOVEMBER 12, 2023

The Board indicated that a “What We Heard” document will be released in 2024. The deadline for registration in the roundtables is November 24, 2023. The deadline for written submissions in response to the scoping paper is December 20, 2023.

Drug Pricing 52

Drug Pricing Documentation 52

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.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling Communication 52

Pharmaceutical Technology

SEPTEMBER 15, 2022

According to GlobalData’s Drugs Database, Rinvoq and Skyrizi combined are projected to reach global analyst consensus forecast sales of more than $21bn by 2028. Bristol Myers Squibb (BMS) documented a 9.1%

Vaccines 108

Vaccines Drug Pricing Documentation Biosimilars 108

Proxsys Rx

APRIL 1, 2025

Regardless of your answer, theres no question the 340B Drug Pricing Program remains a critical resource for eligible healthcare providers, enabling them to stretch scarce federal resources to provide essential services to underserved communities. Perform self-audits to proactively identify and address your 340B program gaps.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Documentation Drug Pricing 52

Pharma Leaders

JUNE 1, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

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Drug Pricing Documentation 40

Drug Channels

JUNE 18, 2024

This week, I’m rerunning some popular posts while I prepare for Friday’s live video webinar: The 340B Drug Pricing Program: Trends, Controversies, and Outlook. Last week, we documented the substantial concentration of dispensing revenues for specialty drugs. Click here to see the original post from April 2024.

Specialty Pharmacies 52

Specialty Pharmacies Drug Pricing Documentation 52

Drug Channels

MARCH 16, 2021

Click here to download a free report overview (including key industry trends, the Table of Contents, and a List of Exhibits) New Drug Channels Institute Study: The Latest Trends for U.S. Drug Pricing, Reimbursement, and Patient Costs (press release) We’re offering special discounted pricing if you order before March 28, 2021.

Drug Pricing 52

Drug Pricing Documentation 52

Drug Channels

MARCH 15, 2022

drug pricing, reimbursement, and dispensing system. There are loads of internal hyperlinks to help you navigate the document and customize it to your specific interests and priorities. The 2022 Economic Report on U.S. The report has been thoroughly updated with the latest data and includes loads of new material and new sections.

Specialty Pharmacies 98

Specialty Pharmacies Pharmaceutical Manufacturing Drug Pricing Documentation 98

Drug Channels

JULY 21, 2020

Last week, I documented that nearly half of U.S. pharmacies now participate in the 340B Drug Pricing Program. Below, we update our exclusive analysis of the biggest specialty pharmacies within 340B.

Specialty Pharmacies 52

Specialty Pharmacies Drug Pricing Documentation Hospitals 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). This includes collecting data on utilization management practices, formulary changes, and patient experiences.

Drug Pricing 52

Drug Pricing Insurance Coverage and Processing Labelling HIPAA 52

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.

Drug Pricing 105

Drug Pricing Documentation Labelling 105

Safe Biologics

FEBRUARY 1, 2024

EMA Seeks Public Comment on Re-evaluating the Need for Clinical Safety and Efficacy Data in Biosimilar Development On January 25, the European Medicines Agency’s (EMA’s ) Committee for Medicinal Products for Human Use (CHMP) released a document entitled “Concept paper for the development of a Reflection Paper on a tailored clinical (..)

Biosimilars 130

Biosimilars Documentation Drug Pricing 130

pharmaphorum

NOVEMBER 3, 2022

Measures in the leaked document could allow pharma companies to extend their monopolies beyond the end of the original 20-year patent term, and shut down so-called ‘pre-grant’ channels that can currently be used to block unjustified patents before they are granted.

Documentation 85

Documentation Drug Pricing 85

Big Molecule Watch

MARCH 1, 2024

Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program of the IRA. There are now seven remaining lawsuits challenging the Drug Price Negotiation Program of the IRA.

Biosimilars 59

Biosimilars Drug Pricing Dosage Documentation 59

Drug Patent Watch

JANUARY 8, 2025

Proactive measures to protect your patents include: Regular patent portfolio reviews Monitoring competitor activities Maintaining detailed lab notebooks and documentation Implementing strong trade secret protections By staying vigilant, you can often prevent infringement before it occurs or strengthen your position if litigation becomes necessary.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Drug Pricing Documentation 52

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. Gilenya is an oral medication for multiple sclerosis.

Documentation 97

Documentation Hospitals Dosage Drug Pricing 97

pharmaphorum

MAY 14, 2021

Long headquartered in London, the EU drug regulator is now severed from the country both physically and systematically, with its base now in Amsterdam and the UK now assessing drugs through its own regulatory agency, MHRA.

Drug Pricing 59

Drug Pricing Documentation Pharmaceutical Companies Pharmaceutical Companies 59

Ramblings of a pharmacist

FEBRUARY 16, 2022

It’s a well-thought through survey document, but I still have uncertainties about how to answer some of the questions – a part asks how many prescriptions were filled with brands and how many with generics. It’s an invaluable document, even if it isn’t perfect. How much were they?). In other words, the $55.96

Independent Pharmacies 52

Independent Pharmacies Compounding Specialty Pharmacies Prescription Filling 52

Viseven

JANUARY 13, 2023

The list of HEOR competencies includes, but is not limited to, clinical trial design, epidemiology, HEOR modeling, statistics, data mining, collecting and processing statistics and documenting real-world evidence. How Pharmaceutical HEOR Experts impact Drugs Engineering. HEOR Impact on Drug Pricing and Marketing.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Dosage Pharmaceutical Manufacturing 40

Proxsys Rx

APRIL 19, 2024

HRSA issues “Administrative Dispute Resolution” ruling On April 19, HRSA issued a ruling entitled “340B Drug Pricing Program; Administrative Dispute Resolution.” The ruling is an estimated 19,247 words long, or just over 37 pages, printed in single-spaced 10-point Arial.

Specialty Pharmacies 52

Specialty Pharmacies Hospitals Drug Pricing Packaging 52

STAT

FEBRUARY 9, 2023

WASHINGTON — The Biden administration on Thursday offered the first glimpse into how it’s planning to enact a new law that will penalize drugmakers for hiking their prices faster than inflation.

Drug Pricing 246

Drug Pricing Documentation 246

Putting Patients First Blog

APRIL 14, 2023

The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. Created by and for patient organizations over 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy.

Drug Pricing 40

Drug Pricing Drug Development Documentation Communication 40

STAT

SEPTEMBER 15, 2022

In their filing , which was made in 2019, the groups argued that “unlawful conduct” carried out by Gilead had hurt the public interest, because its prices led the government to ration the Sovaldi medication. Continue to STAT+ to read the full story…

Documentation 246

Documentation Drug Pricing 246