The Latest
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Kyverna follows oncology’s CAR-T cell playbook for an ultra-rare autoimmune disorder
The pharma company is tackling the “stiff person syndrome” that afflicts Celine Dion in a phase 2 trial for its lead CAR-T candidate.
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Q&A
Bird flu puts BARDA back in the spotlight
BARDA director Gary Disbrow explains the agency’s focus, how companies can get their “foot in the door” and why platforms are so important for preparedness.
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Q&A
Amylyx’s CEOs on their ALS setback and quest to revamp the pipeline
Co-CEOs Josh Cohen and Justin Klee reflect on what they learned from Relyvrio’s failure and how they’re carrying those lessons forward with other drugs.
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Deep Dive
FDA’s lab developed test rule could be first check on agency’s power post-Chevron
The Supreme Court’s decision to overturn the Chevron doctrine would make it easier to challenge agency regulations, such as the LDT final rule.
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Has pharma emerged from the ‘age of uncertainty’?
An industry reeling from a precarious market is showing signs of stabilizing as the future becomes a little less cloudy, an Evaluate report suggests.
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Biotech Spotlight
Mining clues from a library of brain tissue samples, Cerevance takes a precision approach to CNS disorders
Mid-stage data from the company’s lead candidate in Parkinson’s is expected later this year and could tee up an IPO.
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Is a better CAR-T cell therapy option on the horizon?
In vivo CAR-T cell technology has the potential to solve some major issues in the field and could enter the clinic this year.
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BMS’ long-standing leukemia blockbuster stares down its first generic
Patent disputes in the U.S. and abroad have opened the door to new generics ready for launch as soon as September for BMS’ Sprycel.
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As feds crack down on PBMs for drug costs, Big Pharma could lose some of the heat
Drugmakers pointed the finger at PBMs for being the culprit behind rising drug prices in the U.S. for years — now, an ongoing FTC investigation has their back.
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Pfizer research chief Dolsten to step down, with company at a crossroads
The company has begun searching for a successor to Dolsten, who oversaw more than 35 drug and vaccine approvals alongside notable setbacks during his time as Pfizer’s top scientist.
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As the GLP-1 market booms, other healthcare companies are cashing in
With more Americans taking obesity medications, adjacent businesses are offering supportive services to offset side effects, collect data and foster new health benefits.
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Could pharma’s blockbuster immunotherapies work in dogs?
Vetigenics believes it’s found a way to make pricey antibody-based technologies more accessible for animals.
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FDA approval is just the beginning. Now Lilly’s Kisunla faces the tough Alzheimer’s market.
Recent history suggests an Alzheimer’s approval doesn’t necessarily translate to market triumph. Perhaps for Eli Lilly’s Kisunla, this time could be different.
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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.