PharmaVoice

MARCH 4, 2024

In its zeal to stamp out anticompetitive practices and lower drug prices, a consultant said the FTC might have overlooked the unique considerations in rare disease drug development.

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STAT

FEBRUARY 9, 2024

Also, Moderna’s RSV vaccine efficacy seems lackluster compared to competitors, and the Bernie Sanders drug pricing song-and-dance did not seem to faze pharma CEOs. Our podcast this week centers exclusively on a tantalizing subject: Artificial intelligence in biotech. Give it a listen. Read the rest…

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STAT

SEPTEMBER 26, 2023

Extending patent protection doesn’t just stretch a drug’s profits — in some cases, doing so can lead to its most significant revenue period, according to a recent analysis published by the Initiative for Medicines, Access & Knowledge, or I-MAK, a nonprofit advocating for drug pricing reforms.

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pharmaphorum

FEBRUARY 4, 2022

Our findings also indicated that disease rarity cannot be used to predict the likelihood of reimbursement and thus is not a major driver of reimbursement decisions in either NICE or NHS England value assessments for rare and orphan disease drugs. Link between disease rarity and drug pricing. appeared first on.

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Pharmaceutical Technology

JANUARY 31, 2023

The US omnibus bill passed in late December 2022 will give the agency greater powers to regulate accelerated approval drugs, while the Inflation Reduction Act’s lowering of drug prices will create an uncertain environment for drug developers, he said.

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STAT

FEBRUARY 28, 2024

Damian here with a look at a resurgence in psychiatric drug development, a big day for biotech stocks, and some innovation in the world of quarterly earnings. Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Good morning, everyone.

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STAT

OCTOBER 6, 2022

Buried deep within the Inflation Reduction Act’s drug-price negotiation provisions is language that could open the way to a new era of biomedical breakthroughs and smarter health spending. But it will now be required for some drugs. Doing so used to be illegal.

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European Pharmaceutical Review

JANUARY 2, 2024

According to results from a survey by GlobalData, the top challenges for the pharmaceutical industry in 2024 will be inflation, geopolitical conflict and drug pricing pressures. Data outcomes revealed that most respondents from Pharma considered that drug pricing and reimbursement constraints will have a negative impact in 2024.

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STAT

FEBRUARY 1, 2024

Biotech can’t shake the Fed The XBI, a closely watched index of biotech stocks, turned red for the year yesterday, and not because of a clinical disappointment, a drug pricing scandal, or an M&A rumor that came to nothing. In 2024, as in 2023, the industry’s fate seems inextricable from interest rates.

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STAT

JANUARY 4, 2024

Damian here with an in-depth preview of a certain annual biotech conference, a look at the cutting edge of obesity drug development, and year’s first IPO filing.   Sign up  to get our biotech newsletter in your inbox. Good morning, everyone. Read the rest…

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Putting Patients First Blog

MAY 22, 2023

Driven by the work of the Food and Drug Administration on patient-focused drug development (PFDD), many companies in the biopharmaceutical community have devoted significant resources to better understand patient populations and are working to bring to market products that best suit their needs. Sincerely, Randall L.

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Safe Biologics

JULY 13, 2023

On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines which focused on unintended consequences for patient access that may result from the implementation of the Inflation Reduction Act (IRA).

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Big Molecule Watch

SEPTEMBER 14, 2023

Two weeks ago, HHS announced the first 10 drugs that will be subject to the new Drug Price Negotiation Program under the Inflation Reduction Act (“IRA”). Six of the manufacturers whose drugs are on the list and several other interested groups have filed lawsuits challenging the Program.

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STAT

MAY 4, 2023

but its contributions to drug development are not well understood or recognized by most Americans. The National Institutes of Health may be the largest public funder of biomedical research in the U.S.,

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Safe Biologics

SEPTEMBER 12, 2023

ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines.

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Safe Biologics

OCTOBER 10, 2023

ASBM Statement on Announcement of Medicare Drug Price-Setting List On August 29th, the Centers for Medicare & Medicaid Services (CMS) announced the first 10 drugs selected under its Medicare drug price “negotiation” plan, authorized by the Inflation Reduction Act (IRA) signed into law last year.

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STAT

APRIL 12, 2024

Enjoy, and see you soon… Western drug makers are talking to alternative suppliers in response to draft U.S. legislation seeking to restrict an important Chinese drug developer and manufacturer over national security concerns , The Financial Times explains. But be safe. The Biosecure Act would prohibit U.S.

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STAT

MAY 30, 2023

Meanwhile, we hope you have a meaningful and productive day … Drugmakers have already hinted at suing Medicare over its new efforts to negotiate prescription drug prices, but a new report by nonpartisan congressional researchers suggests there are at least some parts of the law that cannot be challenged.

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STAT

MARCH 16, 2023

As a result, the study authors argued that a decades-old law designed to encourage generic drug development has failed to foster sufficient competition for inhalers and that reforms are needed to create lower-cost options. Continue to STAT+ to read the full story…

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Definitive Healthcare

FEBRUARY 23, 2024

Resource Type E-Books & How-To Guides Blog How-To Guide Healthcare Insight Medical claims 101: What you need to know How to sell effectively to healthcare facilities and executives using the right… Hospital payor mix by state Image Image Image ","nextArrow":" ","appendArrows":".coh-slider-nav-bottom","dots":false,"draggable":true,"swipe":true,"fade":false,"vertical":false,"speed":700,"cssEase":"ease","pauseOnHover":false,"pauseOnDotsHover":false,"autoplay":false,"rows":0},"sm":{"slidesToShow":2,

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STAT

DECEMBER 2, 2024

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Hope you had a restful, tasty holiday. In today’s Readout, we discuss former FDA Commissioner Scott Gottlieb publicly speaking out against the nomination of Robert F. Kennedy Jr.

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Pharmaceutical Technology

MAY 17, 2023

The Inflation Reduction Act, which became US law in August 2022, has invited its fair share of critics and supporters over its drug pricing provisions. While negotiating drug prices is common practice in other major markets, CMS had not previously held the legal authority to do so.

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Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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Safe Biologics

NOVEMBER 12, 2023

Pitts: The IRA makes the risks of developing new drugs too high On September 14th, an op-ed by former FDA Associate Commissioner Peter J. Pitts ran in the Pittsburgh Post-Gazette, in which he highlighted his concerns with Medicare drug price-setting policies stemming from the Inflation Reduction Act (IRA), passed last year.

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STAT

NOVEMBER 26, 2024

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Happy Tuesday! Adam Feuerstein, here, filling in for your regular Readout correspondents. Read the rest…

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STAT

NOVEMBER 21, 2024

Today, some squiddy drug delivery, a leukemia deal between Kura Oncology and Kyowa Kiri, and a new GLP-1 startup from Versant Ventures. Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Read the rest…

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Drug Pricing Drug Development 271

STAT

NOVEMBER 18, 2024

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Today, we talk radiopharmaceuticals, GLP-1s,  psychedelics, cardiomyopathy and more.

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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. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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STAT

NOVEMBER 22, 2024

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Today, more beef in the gene editing space, with Prime Medicine’s CEO getting a little aggressive over patent disputes.

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STAT

NOVEMBER 13, 2024

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, lots of news this morning that we’ll get straight into. Read the rest…

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STAT

NOVEMBER 19, 2024

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Lots today from the American Heart Association’s annual meeting, plus former National Cancer Institute chief Ned Sharpless launches a new biotech called Jupiter. Read the rest…

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Safe Biologics

JUNE 12, 2023

Coming Soon: ASBM/GaBI Webinar on IRA’s Medicare Price Negotiation Provisions ASBM and the Generics and Biosimilars Initiative (GaBI) are in the final planning stages for the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA).

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STAT

NOVEMBER 14, 2024

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, my dear subscribers. This is my last Readout newsletter — just kidding!

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Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE. Read it here.

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Safe Biologics

JULY 20, 2023

REGISTER NOW: July 26th ASBM/GaBI Webinar on IRA Medicare Price Negotiation On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) will host the first of two webinars examining the implications for patients and healthcare providers of the recently-passed Inflation Reduction Act (IRA). REGISTER HERE. Read it here.

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STAT

NOVEMBER 20, 2024

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox.

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Drug Pricing Drug Development 262

STAT

NOVEMBER 5, 2024

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. Hope everyone takes it easy in what will be a long day today. Now let’s get into the biotech news. Read the rest…

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