The Latest
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The FDA pushes concrete plans to further diversity in clinical trials
The long-awaited guidance offers a more detailed road map for pharma.
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Don’t call it a comeback: Biotech’s CNS resurgence forges Big Pharma connections
Neuroscience pipelines are reawakening as biotechs prove to the pharma giants that the field is still worth the investment.
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In the rapidly shrinking COVID market, this company still sees opportunity
GeoVax is developing a next-gen COVID vaccine targeting a population that’s so far been elusive: immunocompromised patients.
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Q&A
How BeiGene is taking on established blockbusters with an expanding blood cancer arsenal
BeiGene’s Brukinsa is the first in a hematology franchise that the company hopes will rival top-sellers and introduce a new lineup of medicines for patients.
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Biotech Spotlight
Protein power: a biotech mining viruses to fight disease
Flagship Pioneering-backed Prologue Medicine is harnessing the evolutionary tactics of viral proteins to systematically find new drugs.
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The IRA will lower U.S. drug spending, CMS finds — but not for awhile
As the first 10 drugs undergo price negotiations with the U.S. government, the latest spending projections reveal soon-to-be-implemented price caps will have an impact by 2027.
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Up-and-comers look for an edge in the bustling ADC field
The next wave of targeted ADC therapies is on the horizon, and these three potential rising stars could help carry the field forward.
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Women with a common hormonal disorder have few good treatment options. Could GLP-1 drugs help?
Obesity drugs like Wegovy are proving useful in many other diseases. Polycystic ovary syndrome, a chronic condition that can cause infertility, may be one.
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Will the real Ozempic please stand up? Lilly, Novo face uphill counterfeit battle
Weight loss market leaders are warning patients and healthcare providers about the risks associated with knockoff versions of their popular obesity meds — and taking legal action.
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Q&A
Can Moderna’s COVID-flu combo shot improve flagging vaccination rates?
A COVID and flu duo could ease manufacturing and administration, potentially driving higher vaccination rates, said Moderna’s VP of North American medical affairs.
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After 33 years, Geron’s first approval marks a turn in Nobel-winning science
The decades-long story of how a first-in-class blood cancer treatment went from bench to bedside.
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Ahead of its upcoming decision date, a competitor takes aim at KarXT
The FDA isn’t slated to render a decision about BMS and Karuna’s potential breakthrough schizophrenia med until September — but a biotech is already hoping to be hot on its heels.
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Q&A // First 90 Days
After an obesity deal with Novo, Omega’s new business head is on the hunt for more partners
With a career focused on striking deals, Kaan Certel is hoping to lead the Flagship-backed biotech with an mRNA platform into its next phase of growth.
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3 windows of opportunity in women’s health
Despite a recent surge of interest, the femtech and women’s health markets are far from reaching their full potential.
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NIH-funded trials fall flat on diversity goals
Many clinical trials aren’t meeting enrollment inclusion checkpoints — and some aren’t even setting targets, according to a recent OIG report.
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New data showcase promise, growing pains of CAR-T in autoimmune disease
One expert described trial results presented at EULAR last week as “unprecedented.” But reports of relapses in some patients drew questions about the therapies’ ultimate potential.
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Avoiding the pharma ‘junk pile’ with launch readiness, pipeline rigor and ‘quick kills’
Drug launches have underperformed expectations at a high rate, and pharmas need to get better at thinning the pipeline to make room for the real wins, says a life sciences consultant.
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The hunt for the brain’s biomarkers
How Roche is finding better ways to diagnose brain conditions like Alzheimer’s and Parkinson’s disease.
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Pfizer’s Paxlovid flunks long COVID study as researchers uncover the condition’s deep toll
While researchers gain ground understanding long COVID’s impact, viable treatments could still be a long way off.
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Lilly’s adcomm win shows amyloid and tau will likely dominate Alzheimer’s — for now
Lilly is the latest to approach the coveted Alzheimer’s approval, but a slate of drugmakers are lining up clinical trials in amyloid and tau to take a shot at improving patient outcomes.
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Making Moves
Regenxbio CEO to step down after 15 years
Kenneth Mills will become chair of the gene therapy developer's board while Curran Simpson, the current chief operating officer, will take his place as company head.
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Despite adcomm rejection, Lykos CEO sees future for MDMA drug
Although the rebuff makes approval “a bit more challenging,” Lykos is moving forward with the psychedelic-based treatment for PTSD.
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Behind the powerful computations, AI’s role in pharma is still beset by challenges
Small biotechs are saving time and money leveraging AI to develop new drugs, but incomplete data and disease complexity remain hurdles for the space.
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As Big Pharma places bigger bets on ADCs, here’s where the field is headed next
With more drugmakers getting into the antibody-drug conjugate game, emerging innovations signal a bright future for the technology.
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FDA’s platform designation aims to ease R&D pain points
A new program creates approval pathways for multiple drugs developed on the same platform.