STAT

STAT+: Up and down the ladder: The latest comings and goings

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

And here is our regular feature in which we highlight a different person each week. This time around, we note that SpliceBio hired Aniz Girach as chief medical officer. Previously, he was chief medical officer at ProQR Therapeutics.

But all work and no play can make for a dull chief medical officer.

Continue to STAT+ to read the full story…

1 year 5 months ago

Pharma, Pharmalot, biotechnology, life sciences, STAT+

STAT

STAT+: Pharmalittle: We’re reading about CVS dropping Humira coverage, pharma layoffs, and more

Rise and shine, everyone, another busy day is on the way. Sadly, gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why?

We will draw on a bit of insight from the Morning Mayor, who taught us that “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us. Remember, a prescription is not required. So no need to mess with rebates. Our choice today is crème brûlée. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. …

Starting April 1, CVS Health will no longer offer AbbVie’s Humira to patients in its commercial prescription plans and, instead, will direct them to biosimilar versions of the anti-inflammatory drug that became available last year, Bloomberg News writes. CVS’s Caremark unit is the first major pharmacy benefit manager to announce such a shift. The move is a blow for AbbVie, which managed to keep Humira on PBM lists of covered drugs even when plans added lower-cost biosimilars. CVS’s Cordavis unit will also start selling a version of Humira with AbbVie in the second quarter, though it will not be preferred on CVS commercial drug plans.

The U.S. Food and Drug Administration is evaluating reports of side effects such as hair loss and suicidal thoughts in people taking medications known as GLP-1 receptor agonists, which are approved to treat diabetes or weight loss, CNN reports. These include Ozempic, Rybelsus, Wegovy, Saxenda, Victoza, Mounjaro, and Zepbound. The FDA is “evaluating the need for regulatory action” after its FDA Adverse Event Reporting System or FAERS received reports of alopecia, or hair loss; aspiration, or accidentally breathing in things like food or liquid; and suicidal ideation in people using these medications.

Continue to STAT+ to read the full story…

1 year 5 months ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

STAT+: Patent thickets and terminal disclaimers: How pharma blocks biosimilars from the marketplace

To ring the register, a pharmaceutical company may create a patent thicket, which involves filing dozens of patents that, in some cases, add little value to their medicines but extend precious monopolies.

To ring the register, a pharmaceutical company may create a patent thicket, which involves filing dozens of patents that, in some cases, add little value to their medicines but extend precious monopolies. And one crucial, but little-known tool for making this happen is something called a terminal disclaimer.

In short, a terminal disclaimer is a stipulation provided to the U.S. Patent & Trademark Office that a continuation or follow-on patent – essentially, a minor patent that makes few substantive changes to a medicine – will expire at the same time as the original patent filed by a pharmaceutical company. By doing so, a drugmaker can circumvent prohibitions on awarding more than one patent for an invention.

As a result, a drug company can quickly add a number of patents that can be used to protect its medicines from would-be rivals. How so? As patents pile up, companies that want to sell generic or biosimilar versions of these medicines find themselves fighting longer and more expensive patent infringement lawsuits that are designed to delay their plans.

Continue to STAT+ to read the full story…

1 year 5 months ago

Pharma, Pharmalot, patents, Pharmaceuticals, STAT+

STAT

STAT+: Pharmalittle: Weight loss drugs are being paired with bariatric surgery; Carl Icahn plans to oust Illumina directors

Top of the morning to you. And a fine one it is. Lots of sunshine and clear blue skies are enveloping the Pharmalot campus, where the official mascots are bounding about the grounds and the short person has departed for a challenging apprenticeship. As for us, we are as busy as ever hunting and gathering items of interest.

We trust you have your own busy agendas. So join us as we hoist the ever-present cup of stimulation — our choice today is gingerbread — and attack the fast-growing to-do list. We hope you have a smashing day and, of course, do stay in touch. Our settings are adjusted to accept postcards and telegrams. …

Activist investor Carl Icahn plans to oust directors at Illumina, laying the groundwork for a second board challenge at the gene-sequencing company months after shareholders elected one of his director candidates, Reuters writes. Icahn disclosed his plans without offering details in a letter to other shareholders less than 24 hours after Illumina said it will divest blood test maker Grail. In Monday’s letter, Icahn blamed the Grail acquisition, which has faced regulatory challenges since 2021, for a 75% drop in Illumina’s share price that he says wiped away $55 billion in value for shareholders. The stock was up more than 2% at $130.39 on Monday.

As more data emerge that obesity drugs like Wegovy can reduce complications from heart and kidney problems as well, scientists have been wondering whether these benefits are driven by weight loss alone or also by other mechanisms. A new study suggests that one possible contributor is the drugs’ ability to reduce inflammation independent of weight loss, STAT tells us. In mice experiments, scientists found that the treatments, known as GLP-1-based drugs, acted through the brain to reduce inflammation throughout the body. This was over a short period of time before the mice lost weight, according to the study, published Monday in Cell Metabolism.

Continue to STAT+ to read the full story…

1 year 5 months ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

The biotech news you missed from the weekend

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Hello from ASH! Writing this Readout from a press room at the annual hematology confab here in San Diego. Today’s edition is chockfull of Vertex content, plus some extras from ASH and elsewhere.

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

Hello from ASH! Writing this Readout from a press room at the annual hematology confab here in San Diego. Today’s edition is chockfull of Vertex content, plus some extras from ASH and elsewhere.

Read the rest…

1 year 6 months ago

Biotech, Business, Health, Pharma, Politics, The Readout, biotechnology, Cancer, drug development, drug pricing, FDA, finance, genetics, Pharmaceuticals, Research

STAT

STAT+: The prices of 8 drugs were hiked without proof of new benefits, costing the U.S. $1.2 billion in 2022, report finds

During 2022, drugmakers substantially raised prices on eight widely used medicines without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $1.2 billion last year, according to a new report.

The drug for which spending increased the most due to a price increase was Humira, which is used to treat rheumatoid arthritis, plaque psoriasis, and other disorders. AbbVie raised the wholesale price by 7.1%. The net price — after rebates and discounts — rose by 1.9%, most likely because the company offered more concessions than previously.

Consequently, spending for this drug climbed by $386 million, according to the report issued by the Institute for Clinical and Economic Review, a nonprofit that assesses the cost-effectiveness of medicines. The report noted that the manufacturer disputed the findings, calling the methodology “flawed” and arguing that the analysis was “subjective.”

Continue to STAT+ to read the full story…

1 year 6 months ago

Pharma, Pharmalot, drug pricing, Pharmaceuticals, STAT+

STAT

STAT+: Pharmalittle: Biden pharma patent proposal spurs fears; Klobuchar questions company behind price spike of lead poisoning antidote

And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is still shaping up, but we do plan to tidy the grounds, promenade with the official mascots, and catch up on our reading. We also hope to hold another listening party with Mrs.

Pharmalot and the rotation will likely include this, this, this, and this. And what about you? With holidays unfolding, you could head to your local temple of consumption and give the economy a boost. You could also plan an end-of-year getaway or, perhaps, you might soak in the great outdoors with a ride in the country or a walk in the park. Well, whatever you do, have a grand time. And be safe. Enjoy, and see you soon. …

After months of deliberation, the Biden administration disclosed plans to sidestep patents in order to lower costs for some pricey medicines that were discovered with taxpayer money. But the move, which must still be finalized by an inter-agency working group, is already causing uncertainty over the extent to which drugmakers may lose valuable monopolies and consumers will save money, STAT explains. This reflects the seemingly contradictory approach the administration has taken toward the controversial concept, as well as open-ended language in the proposal. As a result, there is a mix of fear and doubt as the pharmaceutical industry and patients try to envision the eventual terms.

The $32,000 cost of a crucial drug to treat severe lead poisoning drew ire from U.S. Sen. Amy Klobuchar (D-Minn.), who wrote a letter to Rising Pharmaceuticals seeking answers on how the company reached its price, CNN says. The drug costs almost 10 times more than an imported version of the medicine from France, which the U.S. Food and Drug Administration had allowed to be used in the U.S. while the drug was in shortage. Toxicologists says the price can make it difficult for hospitals to stock the medicine, called calcium disodium EDTA, potentially leading to delays of days when patients need urgent treatment. EDTA is used for the most severe cases of lead poisoning.

Continue to STAT+ to read the full story…

1 year 6 months ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

Eli Lilly’s latest $1.4 billion deal might come unglued

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Good morning, everyone. Damian here with another multibillion-dollar deal, a word on the future of Sanofi, and a setback in one of medicine’s longest-running quests.

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. Damian here with another multibillion-dollar deal, a word on the future of Sanofi, and a setback in one of medicine’s longest-running quests.

Read the rest…

1 year 6 months ago

Biotech, Business, Health, Pharma, Politics, The Readout, biotechnology, drug development, drug prices, drug pricing, finance, Pharmaceuticals, Research, vaccines

STAT

STAT+: Pharmalittle: White House takes aim at pharma patents to lower drug prices; Sanofi CEO defends reducing earnings forecast

Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say, “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us.

Remember, a prescription is not required. So no need to mess with rebates. Our choice today is chocolate raspberry. Meanwhile, here are a few items of interest. Hope you have a smashing day and, of course, do stay in touch. …

The White House is throwing its support behind a controversial authority that allows the government to claw back patents for certain high-priced medicines, STAT tells us. The move is an early step that could have major ramifications for the pharmaceutical industry, depending on whether and how federal officials actually use the authority. The administration will issue a framework for the U.S. National Institutes of Health to more broadly use march-in rights, a policy that allows it to seize patents from drugmakers whose products rely on federally funded research. The framework will detail when the agency might assert this authority, and endorse using drug prices when deciding.

AbbVie announced plans to purchase Cerevel Therapeutics and its pipeline of experimental neurological and psychiatric medications for $8.7 billion, STAT writes. The deal marks the second billion-dollar acquisition by AbbVie in under a week. Facing the prospect of declining sales from two of its best-selling drugs, the company also acquired Immunogen and its ovarian cancer treatment for $10 billion last week. With this latest deal, AbbVie will acquire several clinical-stage molecules for Parkinson’s, schizophrenia, and epilepsy, among other disorders, many of which previously belonged to one of its biggest rivals.

Continue to STAT+ to read the full story…

1 year 6 months ago

Pharma, Pharmalot, pharmalittle, STAT+

STAT

Most drugmakers have so far ignored looming FTC deadline to withdraw or amend wayward patents

With 10 days to go, only one company has responded to a demand by the U.S.

With 10 days to go, only one company has responded to a demand by the U.S. Federal Trade Commission for several brand-name drugmakers to delist dozens of patents that were improperly or inaccurately listed in a government registry, according to a source familiar with the matter.

As a result, the agency is readying plans to file lawsuits against the other companies, some of which are among the biggest drugmakers in the world, such as AbbVie, AstraZeneca, and GSK. The FTC notified the companies on Nov. 7 that they must withdraw or amend the patent listings, or an individual must certify under penalty of perjury that the listings comply with federal law and regulations.

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1 year 6 months ago

Pharma, Pharmalot, FTC, patents, Pharmaceuticals

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