FDA’s Woodcock on authorizing emergency use for hydroxychloroquine: ‘We did the best we could’
Over the past few weeks, the Food and Drug Administration has been criticized for some…
Category: drug development
Why was an unknown federal bureaucrat involved in Trump’s emergency hydroxychloroquine authorization?
WASHINGTON — Rick Bright, an otherwise unknown federal bureaucrat, burst onto the political stage this…
FDA approves pill for aggressive breast cancer that’s spread in the body
U.S. regulators on Friday approved a new drug for an aggressive type of breast cancer…
STAT Plus: Dozens of financial firms want pharma to place Covid-19 patients over profits
More than three dozen asset managers, pension funds, and insurers are urging the pharmaceutical industry…
NIH partners with 16 drug companies in hopes of accelerating Covid-19 treatments and vaccines
WASHINGTON — The National Institutes of Health on Friday announced it would launch a sweeping…
STAT Plus: Drug industry conferences are going virtual. Here’s how not to present data on Zoom
The coronavirus pandemic has upended the way the drug industry presents its data. In recent…
European Union urges the World Health Assembly to pursue a voluntary pool for Covid-19 products
In a significant development, the European Union has proposed a draft resolution urging the World…
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STAT Plus: Zai Lab targets blood cancers in deal with Regeneron
Shanghai’s Zai Lab (ZLAB) is adding a blood cancer drug to its pipeline through a…
STAT Plus: Study of AstraZeneca’s top-selling cancer drug stopped early for ‘overwhelming’ benefit
AstraZeneca halted a study of its lung cancer treatment Tagrisso after observing what the company…
Some drugs being tested as Covid-19 treatments could be very cheap to make
Some existing medicines that may be repurposed to fight Covid-19 could also be manufactured profitably…
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STAT Plus: How will the pandemic shape biotech in the months ahead? An industry analyst weighs in
The biopharma industry is racing to respond to the novel coronavirus pandemic. But the industry…
Opinion: Amid the Covid-19 pandemic, it is time for biomedical research investments to pay off
The Covid-19 pandemic is the monumental public health challenge the medical community has been fearing…
Opinion: Searching for an effective Covid-19 treatment: promise and peril
In response to the most serious global health threat in a century, the world’s biomedical…
The coronavirus sneaks into cells through a key receptor. Could targeting it lead to a treatment?
Nearly 20 years ago, when a different coronavirus struck, Michael Farzan and his team figured…
Data for Regeneron arthritis drug in coronavirus could come in weeks
Regeneron could release data within weeks about how well its arthritis drug Kevzara is battling…
Pfizer says coronavirus drug could enter testing by fall
Pfizer said Thursday it now intends to start human tests on a potential drug to…
STAT Plus: Roche partners with Arrakis Therapeutics to develop drugs that target RNA
Last year, Arrakis Therapeutics announced early but important progress toward a drug-development goal long thought…
Former Novartis exec wants to repurpose generic drugs to fight Covid-19
As Covid-19 sweeps the globe, a growing number of efforts are underway to quickly research…
Fact-checking Trump’s claims about hydroxychloroquine, the antimalarial drug he’s touting as a coronavirus treatment
WASHINGTON — President Trump can’t seem to stop talking about hydroxychloroquine. There is currently no…
WHO director-general endorses a voluntary intellectual property pool to develop Covid-19 products
Amid the race to find a salve for Covid-19, the World Health Organization director-general has…
Data for Gilead’s potential coronavirus therapy are coming soon. Here’s what you need to know
This month, the world should get the first results from a clinical trial testing the…
Martin Shkreli is trying to use the coronavirus pandemic to get out of prison
Martin Shkreli, currently serving a seven-year sentence for securities fraud, has a pitch to authorities:…
STAT Plus: Alnylam and Dicerna, onetime rivals, announce a ceasefire
Rival biotechs Alnylam and Dicerna are announcing a ceasefire. The two companies, which are both…
STAT Plus: Immunomedics halts late-stage clinical trial, confirming drug benefit for aggressive type of breast cancer
Immunomedics is stopping a Phase 3 clinical trial due to “compelling evidence of efficacy” demonstrated…
GlaxoSmithKline and Vir aim to take on Covid-19 with antibodies and CRISPR
The drug giant GlaxoSmithKline said Monday it will collaborate with Vir Biotechnology on experimental treatments…
This tiny federal agency was built to respond to a crisis like coronavirus. Now that it’s here, is BARDA ready?
WASHINGTON — It seems like an agency tailor-made for a crisis like the coronavirus pandemic….
STAT Plus: Two companies bet on ‘chemogenetics’ to sidestep challenges with neurological drug development
For years, pharmaceutical companies have cut back on drug development that targeted neurological conditions. After…
Rudy Giuliani wants FDA to fast-track a stem cell therapy for Covid-19; critics see political meddling
Rudy Giuliani, President Trump’s personal attorney, is urging the Food and Drug Administration to fast-track…
STAT Plus: FDA closes review of Novartis data integrity scandal without punishing the drug maker
An embarrassing scandal that Novartis (NVS) endured over data integrity has quietly come to a…
STAT Plus: ‘It’s the disparity in who gets affected’: A sickle cell doctor tracks dollars and drug development
Sickle cell disease and cystic fibrosis are both rare, genetic diseases. While there are three…
STAT Plus: AC Immune bets that its Alzheimer’s trial design could provide a cleaner test of the amyloid hypothesis
The fate of aducanumab, a potential Alzheimer’s treatment from Biogen, is widely seen as the…
What if hydroxychloroquine doesn’t work? What if it does? Right now, we don’t know
An old malaria medicine, hydroxychloroquine, has gone viral on the internet. But is it really…
STAT Plus: Could real-world evidence help shape the future of drug development?
Real-world evidence has been generating a stir in the world of drug development — and…
‘Drug development is a long, long process’: pharma CEO in Italy sounds a note of caution on Covid-19
The CEO of a global pharmaceutical company’s operations in Italy has advice for anyone expecting…
STAT Plus: STAT Plus video chat: Biotech in uncharted territory
Every corner of the biotech industry is being impacted by the coronavirus pandemic. There will…
Under intense criticism, Gilead forsakes monopoly status for its experimental Covid-19 drug
In an unexpected move, Gilead Sciences (GILD) has asked the Food and Drug Administration to…
STAT Plus: Despite investments and advocacy, pharma’s still making its drugs in batches that can take months — rather than continuously. Why?
WASHINGTON — Former FDA Commissioner Scott Gottlieb said so-called continuous manufacturing would prevent drug shortages,…
STAT Plus: Startup Spotlight: Carisma Therapeutics wants to make a cell therapy that will work in solid tumors
When Michael Klichinsky was rotating through University of Pennsylvania hospitals as a pharmacy student more…
As Covid-19 spreads, disruptions to clinical trial and drug development accelerate
The disruption of clinical trials due to the novel coronavirus pandemic is becoming an almost…
Listen: Trump’s coronavirus pivot, life inside the ICU, drug development in a pandemic
Why did the U.S. change its tune on coronavirus? What’s it like to be an…
A drug maker recently doubled the price of chloroquine — but in response to the coronavirus pandemic, it’s cutting it in half
WASHINGTON — A company that makes a medication increasingly touted as a promising coronavirus treatment,…
Drug makers are racing to develop immune therapies for Covid-19. Will they be ready in time?
In the 1995 movie “Outbreak,” doctors whip up a serum from monkey blood in just…
STAT Plus: Sage has a backup plan for its depression drug: Three new studies aiming for 2022 approval
After meeting with the Food and Drug Administration, Sage Therapeutics said Wednesday that it will…
Opinion: Saving lives should be good business. Why doesn’t that apply to finding new antibiotics?
I have spent my career as a biomedical entrepreneur working to develop products that have…
STAT Plus: Merck drug reduces cough frequency but taste alterations could cloud prospects
An experimental pill from Merck significantly reduced the frequency of chronic coughing compared to a…
Regeneron says potential Covid-19 drugs could start human tests by early summer
The biotechnology firm Regeneron said it has now developed hundreds of potential medicines that could…
STAT Plus: To quell unpredictable allergic reactions, an experimental drug takes aim at a genetic cause, not symptoms
The last time Melanie Wardell was thrown into anaphylactic shock, an ad for Macy’s was…
A new paper about a Gilead drug to combat coronavirus has some analysts skittish about success
As anticipation mounts over the prospects for an experimental Gilead Sciences (GILD) drug to combat…
How one company made $208 million on an untested coronavirus vaccine
Inovio Pharmaceuticals (INO), a drug company that has existed for four decades without developing an…
Opinion: Mending the broken social contract for pharmaceutical pricing and innovation
The biopharmaceutical industry is under unprecedented assault by the public and politicians. Hostility over launch…