Coronavirus hasn’t developed resistance to Paxlovid. How long can that last?
When the patient came back 10 days later, coughing repeatedly and complaining of headache, Davey…
Category: drug development
National Academies report cites ‘urgent’ need to recruit more diverse participants for clinical trials
The persistent lack of diversity among participants in clinical trials is a critical issue that…
As Congress takes up FDA oversight of dietary supplements, a lobbying showdown looms
You’re reading the web edition of D.C. Diagnosis, STAT’s weekly newsletter about the politics and…
STAT+: Pharmalittle: FDA OKs new type of diabetes drug from Lilly; Early-stage biotechs are juicy targets for M&A surge
Good morning, everyone, and welcome to another working week. We hope the weekend respite was…
STAT+: When biotech acquisitions spike, early-stage startups are prime targets, analysis shows
Experts are predicting a coming surge of mergers and acquisitions in biotech. And if history…
FDA approves Lilly diabetes drug that analysts expect to be a big seller
The Food and Drug Administration said Friday it had approved Mounjaro, a new injection for…
STAT+: Pfizer to buy BioHaven for $11.6 billion, raising hopes for the broader biotech market
Pfizer said Tuesday that it will purchase BioHaven, a maker for migraine drugs, for $11.6…
STAT+: From burst bubble to medical marvel: How lipid nanoparticles became the future of gene therapy
Paddy Doherty leaned back in the narrow hospital bed and watched a bag of clear…
STAT+: Covid shots made Moderna biotech’s biggest star, but what now?
What does a breakout company like Moderna do for an encore? More than a decade…
STAT+: Novartis suspends production of two cancer therapies over potential quality issues
Due to manufacturing issues, Novartis has voluntarily suspended production of two therapies that use nuclear…
Opinion: Exploitation in the name of biomedical innovation cannot be tolerated
Biogen’s announcement on Tuesday that it is “substantially eliminating” its spending on Aduhelm caps a…
STAT+: Illumina, maker of a key tool for drug discovery, to try making new drugs itself
DNA sequencing giant Illumina announced Thursday that it would enter the field of drug discovery,…
STAT+: Congress moves toward reforming FDA accelerated approvals, but with pharma-friendly concessions
WASHINGTON — House lawmakers are moving a little closer toward cracking down on drug makers…
STAT+: Researchers describe the human element in the alchemy behind the Moderna vaccine and other new medicines
Veteran vaccine developer Jacqueline Miller joined Moderna in May 2020, at the height of the…
STAT+: Race is often overlooked in key clinical trial data used to win new drug approvals in Europe
Just two-thirds of the pivotal clinical trials that were used to win prescription drug approvals…
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STAT+: FDA warns Miami University contract testing lab over falsified data, poor quality control
A contract testing laboratory run by Miami University was scolded by the U.S. Food and…
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STAT+: Biogen, fresh off major decisions on CEO and Aduhelm, faces next hurdles
Biogen, a stalwart of the global drug industry for the past four decades, is perilously…
STAT+: FDA suspends early study of Vertex stem-cell therapy for type 1 diabetes
Vertex Pharmaceuticals said Monday that the Food and Drug Administration had suspended an early-stage clinical…
STAT+: Despite biotech slump, veterans of SVB and KKR launch investment firm
Two of the top health care investors at the investment bank SVB Securities and the…
Paxlovid’s failure as a preventative measure raises questions, but doctors still back it as a therapeutic
Pfizer released news late Friday that Paxlovid, the antiviral currently subject to a big push…
STAT+: Pharma R&D payments to European researchers are like ‘dark money’
Due to inadequate disclosure policies, drug company payments to European researchers and institutions for R&D…
STAT+: There’s a new crop of treatments for ADHD in kids. Are they any better?
Parents and doctors now have more tools than ever before to help kids manage symptoms…
Opinion: STAT+: Pharma’s role in value-based care starts with value-based research
Modern medicine has been sculpted by the ever-expanding knowledge of biological processes in conjunction with…
Covid hasn’t given up all its secrets. Here are 6 mysteries experts hope to unravel
For a formidable adversary with plenty of secrets up its sleeve, the coronavirus presented one…
STAT+: Justice Department probes Bausch Health over marketing for dermatology drugs
Bausch Health is being investigated by U.S. authorities in connection with marketing of four medicines…
STAT+: Trying not one, but a three-drug combination to help engineered T cells fight cancer
NEW ORLEANS — For years, Kristin Anderson has been trying to push immunotherapy to work…
Opinion: STAT+: Incentives to spur repurposing of existing generics for novel uses would open a new paradigm in drug R&D
The Drug Price Competition and Patent Term Restoration Act of 1984, better known as the…
Covid vaccines didn’t work for many cancer patients — but researchers are designing a new shot for them
A couple months before the pandemic started, Joseph Ford started experiencing a rash of pinpoint…
STAT+: U.K. readies a Netflix-style subscription payment model for badly needed antibiotics
Amid rising concern over antimicrobial resistance, the U.K. has taken a major step toward becoming…
An mRNA vaccine boost may help CAR T-therapy treat solid cancers
NEW ORLEANS — While CAR T-therapy has cured some people with blood cancers, this form…
Opinion: CMS made the wrong decision on Aduhelm. But there might be a silver lining
The Centers for Medicare and Medicaid Services (CMS) issued on Thursday its hotly debated final…
Medicare finalizes its restrictions on new Alzheimer’s drug, despite pressure from drugmakers
WASHINGTON — Medicare on Thursday finalized its plan to restrict coverage for the controversial, pricey…
STAT+: Advocacy group’s advisory board members defect over Biogen Alzheimer’s drug
The furious debate over Biogen’s Alzheimer’s treatment has now sparked controversy over the Alliance for…
Listen: What’s next for Roche, a debate over second boosters, & Vertex’s recent success
What’s on tap for Roche and its closely followed cancer immunotherapy? Are we all headed…
‘We are not casting a wide enough net’: Rob Perez on how biopharma companies can help out their neighbors
If it wasn’t for a well-placed ad in the paper, Rob Perez might not have…
Opinion: STAT+: Reimagining R&D can cut drug development costs from billions to millions
In the course of our work advising biopharma companies, we are often asked how they…
STAT+: Pharma’s ambitious new antibiotic venture fund makes its first investments
One year after its splashy launch, the AMR Action Fund has made its first investments…
Califf admits the FDA’s Alzheimer’s drug decision impacted experts’ trust in the agency
WASHINGTON — Robert Califf, the new head of the Food and Drug Administration, admitted Thursday…
STAT+: Scientists test tetanus bacteria as a weapon to target pancreatic tumors
Pancreatic cancer has proved one of the most deadly forms of the disease, and the…
STAT+: Aurobindo, major generic drug maker, will close a key U.S. production plant
Aurobindo Pharma, which is based in India and is one of the largest global producers…
STAT+: After a dry spell for cancer immunotherapy, a new target offers a beacon of hope
Oncologists may soon have a new immuno-oncology target in their arsenal. Experts expect the Food…
STAT+: Arrowhead shareholders urged not to approve ‘excessive’ compensation for non-executive directors
In an unusual move, a prominent shareholder advisory firm is urging investors in Arrowhead Pharmaceuticals…
He was creating the building blocks for drug developers worldwide. Then Russia started to bomb Kyiv
It was just last month, with the Covid-19 situation having calmed down in Kyiv, that…
STAT+: Pharmalittle: Insurers balk at opioid payouts to drugmakers and wholesalers; AbbVie settles another Humira biosimilar lawsuit
Good morning, everyone, and how are you today? We are doing just fine, thank you,…
STAT+: FDA effort to improve clinical trial diversity failed to make a difference for Black patients, study finds
Six years ago, the U.S. Food and Drug Administration launched a five-year action plan to…
Opinion: Finding cures faster: Bring the FDA into the 21st century with advanced testing
From every sector, the cry is being raised: “We can’t go back to the way…
Opinion: Inappropriate march-in actions would jeopardize public-private partnerships that make lifesaving medicines possible
For decades, partnerships among government-funded academic institutions and private companies in the United States have…
Opinion: The future of pharma and health care will come in small (molecule) packages
Rightful accolades to Moderna and Pfizer/BioNTech for the Covid-19 vaccines they created and developed in…
STAT+: FDA approves second CAR-T cancer therapy to treat multiple myeloma, opening the door for greater access
The Food and Drug Administration on Monday approved a new CAR-T therapy for multiple myeloma, a…
STAT+: ‘It’s almost negligible’: More top hospitals aren’t offering controversial Alzheimer’s drug Aduhelm
WASHINGTON — Almost no one is prescribing Aduhelm, the controversial new Alzheimer’s treatment that roiled…