Pharmaceutical Technology

JULY 28, 2023

Senator Bernie Sanders has proposed price caps on drugs developed with federal funds, following a political career battling against high drug prices.

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STAT

NOVEMBER 28, 2023

We also talk about how the ARIA stemming from Alzheimer’s drugs isn’t taken seriously enough, and how state and local governments are suing insulin makers over drug prices. 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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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

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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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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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

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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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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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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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

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 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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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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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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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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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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STAT

APRIL 9, 2024

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with an update on the biotech market, a look at the future of genome editing, and the evolving definition of “insider trading.” ” Read the rest…

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STAT

APRIL 11, 2024

Damian here with a look at a biotech deal with a lengthy backstory, the tyranny of gas prices, and the latest shakeup at BIO. Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Read the rest…

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STAT

APRIL 4, 2024

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Hey, it’s Meghana. Today, we see how the GLP-1s might be harnessed for Parkinson’s, we learn about species de-extinction efforts, and BIO’s CEO tells us why the U.S.

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STAT

APRIL 12, 2024

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with what is my final edition of The Readout on my last day at STAT.

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STAT

APRIL 5, 2024

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Meghana here. Today, we’re encouraging you to look elsewhere within the STAT universe for fantastic content.

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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

MARCH 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. Hi, it’s Meghana. Today, Illumina finally finds an advocate in the EU, a CRISPRed pig kidney is transplanted into a living human, and more. Read the rest…

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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

APRIL 10, 2024

Also, advocates press the federal government to encourage manufacturing for the prostate cancer drug Xtandi. 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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STAT

MARCH 27, 2024

Damian here with the details on a potentially major drug approval, an idea to make CAR-T more equitable, and the slow launch of a gene therapy. New biotech newsletter launching tomorrow. Don’t miss out. Good morning, everyone. Read the rest…

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STAT

MARCH 25, 2024

New biotech newsletter launching this Thursday. Don’t miss out. Today, we discuss the implications of the Supreme Court’s forthcoming mifepristone evaluation on the FDA and the biopharma industry. We also examine how Covid-19 vaccine makers are faring today, and more. Read the rest…

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STAT

MARCH 28, 2024

Today, we’re reading about the world’s costliest drug, plus we learn about immune senescence and a potential cause for a kidney autoimmune disease. Sign up to get it in your inbox here. It’s Meghana.

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STAT

APRIL 3, 2024

Today we talk about how biopharma plans to harness AI for clinical trial design, why two experts think Medicare ought to cover the costly GLP-1 drugs, and what news from Roivant means for its business strategy. Want to stay on top of the science and politics driving biotech today?  Read the rest…

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STAT

MARCH 29, 2024

Want to stay on top of the science and politics driving biotech today?    Sign up  to get our biotech newsletter in your inbox. Hello, everyone. Damian here with a look at key Supreme Court decision, the latest biotech IPO, and intrigue over Chinese outsourcing. Read the rest…

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STAT

MARCH 14, 2024

Damian here with a reminder that my colleague Ed Silverman is hosting a discussion today about the long-awaited arrival of Humira biosimilars and all they portend for drug costs, insurance coverage, and pharma revenues. Want to stay on top of the science and politics driving biotech today?  Hello, everyone.

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