The Latest
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Psychedelics haven’t fulfilled clinical expectations, but new trial strategies could turn the tide
Leading companies in the psychedelics space have had trouble crossing the regulatory threshold. Here’s where they’re going wrong — and how to fix it.
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A drug for fewer than 1,000 patients? Awareness and diagnosis are key.
Zevra Therapeutics is building a commercial strategy for an ultra-small patient pool.
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Trump’s tariffs could put more pressure on the U.S. to produce generic drugs. Are we ready?
The push to bring generic drug production back home has failed to reach a critical mass.
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GSK taps a startup for shot at Alzheimer’s drug
The collaboration deal, which could be worth hundreds of millions of dollars, is a “pivotal moment” for Muna Therapeutics, a startup that launched less than four years ago.
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Q&A
How Astellas juggles the moving parts of cancer precision medicine development
While developing its first-in-class gastric cancer drug Vyloy, Astellas had to coordinate with another pharma giant to usher the precision med into the market.
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With Makary set to face FDA commissioner hearings, how deep do his industry ties run?
Dr. Marty Makary’s conflicts of interest could come into question before he is confirmed as the next FDA commissioner.
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The big rebrand: Why these 4 biopharmas changed their name this year
Four companies that refreshed their mission and public persona with a new look.
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Can the girl power of Arrivo’s depression drug help reverse its fortunes?
After failing a mid-stage trial, the biotech shifted course and is now targeting females with the goal of proving gender can play a role in depression outcomes.
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Note from the Editor-in-Chief
A change in ownership and what it means for our readers.
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How Alexion markets a rare disease drug by ‘starting with the end in mind’
The biopharma, now an arm of AstraZeneca, needs to build the plane while flying it to be first in rare diseases with no other option.
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Milk-based therapies could be coming. This biotech CEO is aiming to lead the way.
Intrinsic Medicine is entering phase 2 trials in Parkinson’s disease and IBS for its human milk oligosaccharide drug candidates next year.
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Specialized CROs aim to boost participation among women and other underrepresented groups
Lindus Health’s women-focused CRO is the latest in a handful of research efforts to target specialized — and underrepresented — populations.
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How the incoming administration could impact FTC’s approach to pharma M&A
Pharma companies looking to get a break from the FTC under a new administration may be out of luck.
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Q&A // Biotech Spotlight
An RNA biotech draws the blueprint for a late-stage Dravet syndrome trial and beyond
Stoke Therapeutics is entering phase 3 with its RNA medicine designed to treat a rare epileptic condition.
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Trump nominees want to slash and burn agencies. Will RFK Jr. and Oz do the same in healthcare?
Both Trump appointees have promised to bring sweeping changes to several healthcare agencies.
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Johns Hopkins surgeon Makary is Trump’s pick to lead FDA
A prolific medical research and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.
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Will Walgreens’ store closures derail its clinical trial aims?
Despite a plan to shutter 1,200 stores, the company’s chief clinical trials officer said the pharmacy juggernaut remains committed to drug research.
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Keytruda represents almost half of Merck’s sales, and a new formulation could fend off rivals
A subcutaneous version of Merck’s Keytruda was as effective as the infused version in a late-stage study, but the company won’t be the first to market.
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Pfizer, under pressure to change, names oncology head as new R&D chief
Chris Boshoff will replace Mikael Dolsten, who’s stepping down after 15 years leading research at the drugmaker.
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What might a Trump administration mean for the Biosecure Act?
It’s still likely U.S. biotechs and pharmas will have to cut ties with key Chinese partners — it’s just a matter of when.
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What is a ‘cure,’ really? AbbVie’s Humira creator leaps into the next phase of medicine
AbbVie’s head of R&D cures has lofty ambitions to end diseases like HIV through a community of researchers that work as one.
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The Dodgers’ World Series run brought attention to a rare disease. Annexon is stepping up to the plate.
The company is looking to score an FDA nod for its investigational therapy that targets a molecule linked to Guillain-Barré syndrome and other autoimmune diseases.
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Why Merck rolled the dice on an ‘unbelievable’ early-stage brain cancer drug
Merck’s acquisition of Modifi Biosciences bucks common M&A trends in pharma.
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The first MASH drug could open the door for others — including GLP-1s
With only one approved drug on the market, companies like Inventiva Pharma are advancing MASH drugs and seeking a competitive edge.
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Where are they now? 4 biotechs that soared then crashed during the pandemic
How Novavax and others have restructured and trudged forward after their COVID-era high.