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STAT+: Pharmalittle: We’re reading about pharma delaying launches in Europe, Lilly and Biogen deals, and more
Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and balmy breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is raspberry hibiscus. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips. …
Drugmakers are delaying launches of some new medicines in Europe as the industry grapples with U.S. pressure and pricing policy shifts from President Trump, according to Reuters. The White House has been pushing to lower the cost of prescription drugs in the U.S., which has traditionally paid significantly more than other wealthy countries. Trump says the industry has been unfair to U.S. consumers and has sought to tie the cost for Americans to what is paid elsewhere, including in Europe, known as most-favored-nation pricing. That has led drugmakers to press pause on bringing some drugs to European markets, where health spending is lower, to avoid lowering prices in the $700 billion U.S. market. It has also created a complex balancing act for chief executive officers and Europe’s health care policy makers.
Eli Lilly agreed to buy Centessa Pharmaceuticals, the maker of an experimental drug meant to combat sleeping conditions, for roughly $6.3 billion in cash, STAT notes. Centessa, which was publicly launched in 2021, started with more than a dozen programs across a range of diseases, but over the years it has focused on disorders that leave people struggling to stay awake. Its lead drug has been tested in Phase 2 studies in different types of narcolepsy and idiopathic hypersomnia. Centessa is behind Takeda Pharmaceuticals, which has submitted a drug for narcolepsy type 1 to regulators for review, and Alkermes, which plans to start a Phase 3 program for its narcolepsy treatment this year.
Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and balmy breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is raspberry hibiscus. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips. …
Drugmakers are delaying launches of some new medicines in Europe as the industry grapples with U.S. pressure and pricing policy shifts from President Trump, according to Reuters. The White House has been pushing to lower the cost of prescription drugs in the U.S., which has traditionally paid significantly more than other wealthy countries. Trump says the industry has been unfair to U.S. consumers and has sought to tie the cost for Americans to what is paid elsewhere, including in Europe, known as most-favored-nation pricing. That has led drugmakers to press pause on bringing some drugs to European markets, where health spending is lower, to avoid lowering prices in the $700 billion U.S. market. It has also created a complex balancing act for chief executive officers and Europe’s health care policy makers.
Eli Lilly agreed to buy Centessa Pharmaceuticals, the maker of an experimental drug meant to combat sleeping conditions, for roughly $6.3 billion in cash, STAT notes. Centessa, which was publicly launched in 2021, started with more than a dozen programs across a range of diseases, but over the years it has focused on disorders that leave people struggling to stay awake. Its lead drug has been tested in Phase 2 studies in different types of narcolepsy and idiopathic hypersomnia. Centessa is behind Takeda Pharmaceuticals, which has submitted a drug for narcolepsy type 1 to regulators for review, and Alkermes, which plans to start a Phase 3 program for its narcolepsy treatment this year.
The acquisition of Tubulis GmbH—Gilead Sciences’ latest of the year after buying Arcells and Ouro Medicines—brings into the fold a novel ovarian cancer candidate that has demonstrated promising mid-stage data.
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STAT+: Pharmalittle: We’re reading about FDA backing domestic production, another Gilead deal, and more
Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and comfortable breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is ginger peach. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips. …
The U.S. Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs, STAT notes. FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers. The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. One of the legislative proposals in the FDA’s budget justification would let domestic manufacturers of generic drugs challenge brand drug patents a month before foreign companies, a major advantage in an intensely competitive process.
Two more drugmakers, AbbVie and Genentech, will officially start selling their medicines on the TrumpRx website, CBS News tells us. Abbvie, which struck a deal with the Trump administration in January to cut the cost of certain medicines, will sell Humira, a popular medication used to treat rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, on the site at an 86% discount. The prescription prices on the site, however, are only available to patients who are uninsured, or whose insurance does not cover it, and who must pay the full list price out of pocket. Those with insurance coverage generally pay lower prices already. TrumpRx now sells over 61 drugs at a lower price, up from about 40 when the website went live in February.
Rise and shine, everyone, another busy day is on the way. And it is getting off to a good start here on the Pharmalot campus, where clear blue skies and comfortable breezes are greeting us. Who could ask for anything more? Actually, we could — it is time to reheat the kettle for another cuppa stimulation. Our choice today is ginger peach. And here is a helpful tip — a teaspoon of honey enhances the flavors splendidly. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few tidbits to help you along. As always, do keep in touch. We appreciate feedback, criticism, and tips. …
The U.S. Food and Drug Administration used the president’s budget to propose policies aimed at encouraging domestic development and manufacturing of drugs, STAT notes. FDA Commissioner Marty Makary has said the agency needs “giant, big ideas” to counter China’s dominance in early-stage clinical development of drugs. Among the FDA’s ideas are proposals to make it easier to run early-stage trials in the U.S. and to hand an advantage to U.S.-based generics manufacturers. The Trump administration has been using a variety of policy levers to try and bring drug manufacturing to the U.S. One of the legislative proposals in the FDA’s budget justification would let domestic manufacturers of generic drugs challenge brand drug patents a month before foreign companies, a major advantage in an intensely competitive process.
Two more drugmakers, AbbVie and Genentech, will officially start selling their medicines on the TrumpRx website, CBS News tells us. Abbvie, which struck a deal with the Trump administration in January to cut the cost of certain medicines, will sell Humira, a popular medication used to treat rheumatoid arthritis, Crohn’s disease, and ulcerative colitis, on the site at an 86% discount. The prescription prices on the site, however, are only available to patients who are uninsured, or whose insurance does not cover it, and who must pay the full list price out of pocket. Those with insurance coverage generally pay lower prices already. TrumpRx now sells over 61 drugs at a lower price, up from about 40 when the website went live in February.
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FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes
FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes
Aiming to protect patients, the FDA sent lawmakers a wish list of legislative proposals intended to clarify and expand its oversight of updates to approved drug production processes. Read More
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STAT+: Pharmalittle: We’re reading about FDA backing domestic production, another Gilead deal, and more
FDA Seeks Expanded Authority To Regulate Postapproval Manufacturing Changes
Sanofi Bispecific Scores in Asthma, Rhinosinusitis, but Eczema Bet Doesn’t Pay Off
STAT+: Gilead to buy cancer biotech Tubulis for more than $3 billion
Gilead continues dealmaking streak with $3.15B Tubulis buy for ADCs
Illinois’ financial crisis could bring the state to a halt
The final 6 ‘Game of Thrones’ episodes might feel like a full season
New Season 8 Walking Dead trailer flashes forward in time
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Meet Superman’s grandfather in new trailer for Krypton
Disney’s live-action Aladdin finally finds its stars
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