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Opinion: Bashing accelerated approval isn’t supported by the data
The Food and Drug Administration’s accelerated approval program aims to speed “approval of drugs that…
Category: drug development
Opinion: An FDA pathway can accelerate innovation for Duchenne muscular dystrophy
In human biology, the protein dystrophin is a shining example of Joni Mitchell’s classic line,…
STAT+: Animal rights group urges SEC to investigate Charles River over monkey purchases
A leading animal rights group has asked securities regulators to investigate Charles River Laboratories for…
Amylyx’s Relvyvrio data was, as promised, disappointing
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STAT+: Intra-Cellular reports positive results in depression study aimed at expanding use of antispsychotic medicine
Intra-Cellular Therapies reported positive results Tuesday from a late-stage clinical trial seeking to expand the…
A two-decade bet on Seagen pays off
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What about the company Vertex didn’t buy?
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STAT+: Pharmalittle: We’re reading about AstraZeneca CEO pay, alternatives to WuXi and more
And so, another working week will soon draw to a close. Not a moment too…
Gas prices are hurting biotech
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AskBio CSO steps down, has new project in stealth mode
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STAT+: Cancer vaccines gain momentum, after years of disappointing results
SAN DIEGO — Cancer vaccines have traveled a potholed road over the last decade. But…
Pfizer’s plot to win the RSV vaccine race
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STAT+: Big biotech names roll out Seaport Therapeutics, as interest in neuropsychiatric drugs swells
The team behind Karuna Therapeutics, which was recently snapped up in a multibillion-dollar deal, on…
Sanofi resolves most Zantac litigation
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How resurrecting extinct species might impact medicine
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Parkinson’s disease may be helped by GLP-1 drug, new study finds
The booming class of GLP-1 drugs that includes Ozempic and Wegovy is not only effective…
STAT+: Early data from rare-disease trial put spotlight on Moderna’s efforts to turn mRNA into medicines
LONDON — Moderna may be best known for its Covid-19 vaccine, but since its start,…
New data on liquid biopsy for colorectal cancer detection still underwhelms
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Lawmakers want to add more Chinese biotechs to defense list
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STAT+: Roivant autoimmune drug succeeds in Phase 2 study in eye condition
A drug being developed by a Roivant subsidiary for a range of autoimmune conditions succeeded…
What’s Congress going to do with WuXi?
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How GLP-1’s moved from research labs to national TV
Today is the inaugural publishing day for Adam’s Biotech Scorecard — a subscriber-only newsletter offering…
Who can sue the FDA? Answering Justice Alito’s question from the mifepristone arguments
WASHINGTON — Supreme Court Justice Samuel Alito had a clear question at Tuesday’s arguments over…
Brazil’s plan for low-cost CAR-Ts
New biotech newsletter launching tomorrow. Don’t miss out. Good morning, everyone. Damian here with the…
STAT+: Roche subsidiary Foundation Medicine opens new headquarters in Boston
Contemporary paintings by artists who have overcome homelessness or disabilities greet visitors in the lobby….
Merck’s next big thing is (probably) on the way
New biotech newsletter launching this Thursday. Don’t miss out. Hello, everyone. Damian here with a look…
STAT+: Vertex Pharmaceuticals is considering relocating its headquarters
When Vertex Pharmaceuticals moved from Cambridge to Boston’s Seaport a decade ago, it signaled that…
How will the Supreme Court’s mifepristone decision impact biopharma?
New biotech newsletter launching this Thursday. Don’t miss out. Hey there. Today, we discuss the…
SCOTUS’ abortion pill mifepristone case is really about the FDA
WASHINGTON — The Supreme Court on Tuesday will hear opening arguments in an abortion medication…
FDA approves new drug to protect immune compromised from Covid-19
The Food and Drug Administration on Friday authorized a new antibody to protect immunocompromised individuals…
STAT+: How biotech investors spot opportunity when stocks are down — and up
Following a blockbuster year of dealmaking and a recent uptick in biotech stocks, top investors…
EU adviser says Illumina merger was not problematic
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STAT+: Drug development was once a marathon. New tools and timelines are turning it into a sprint
Drug development is more of a sprint than a marathon these days, thanks to more…
Top U.S. addiction researcher calls GLP-1 data for addiction ‘very, very exciting’
Early data regarding the use of GLP-1 medications like Ozempic and Wegovy to treat addiction…
BioNTech is having its Pfizer moment
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Novo is building a really big computer
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STAT+: As targeted radiation field heats up, AstraZeneca to pick up Fusion Pharmaceuticals in $2 billion deal
LONDON — AstraZeneca said Tuesday it would acquire Fusion Pharmaceuticals in a deal worth more…
Contineum Therapeutics files for IPO
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What happens when an approved drug doesn’t work?
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Listen: A dilemma in ALS, the first MASH drug, & why gene therapy is hard
What happens when an approved drug doesn’t work? Why don’t patients want gene therapy? And…
Study: Gilead antiviral drug shows promise as a treatment for Ebola Sudan
A new study suggests the antiviral drug obeldesivir may be effective in curing Ebola Sudan…
Is CAR-T safe for early-stage patients?
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Geron’s resurgence might have been short-lived
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After Amylyx ALS trial failure, patients share disappointment and fear — but some hope
The news last week that a Phase 3 trial of Amylyx Pharmaceuticals’ amyotrophic lateral sclerosis…
When did Wall Street sour on Lilly’s Alzheimer’s drug?
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Preventing the weaponization of AI-designed proteins
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STAT+: Amylyx ALS drug failure leaves patients, advocates, and researchers reeling — and wondering what’s next
The latest disappointment in amyotrophic lateral sclerosis research brought crushing news for patients and physicians,…
Eli Lilly’s anti-vanity ad campaign for Oscars
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Opinion: STAT+: It’s time to rethink everything about our approach to psychiatric drug development
In many ways, psychiatry is still flying blind. People experiencing mental health conditions are prescribed…
Banning WuXi is more complicated than it might sound
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