STAT Plus: Sarepta’s gene therapy for limb-girdle disease shows improved muscle function after one year
Sarepta Therapeutics said Monday that three children born with a rare muscle-wasting disease called limb-girdle…
Category: drug development
Opinion: Covid-19 is changing the game for health care companies and investors
Even as the health care industry has stepped up with an unprecedented response to the…
STAT Plus: In a first for RNA-modifying drugs, AstraZeneca partners with startup Accent Therapeutics
Drug giant AstraZeneca is moving deeper into RNA-based therapies with a new partnership with the…
STAT Plus: Recapping ASCO 2020, talking cancer therapy combinations, and looking to the future
Before it even started, ASCO 2020 was one for the books. Held virtually for the…
Opinion: Create a health impact fund to spur development and equitable use of a Covid-19 vaccine
Calls for rethinking our pharmaceutical innovation system are swirling in the headwinds and tailwinds of…
Opinion: It’s time to bring generic drug manufacturing back to the U.S.
In a hearing Tuesday afternoon on Capitol Hill, policymakers will consider repatriating America’s drug supply…
STAT Plus: Pharmalittle: Stressed Americans cause a shortage of an antidepressant; Dems attack GOP candidates over malaria drug
Rise and shine, another busy day is on the way. And it feels particularly busy….
STAT Plus: Despite protest, industry group backs use of horseshoe crab blood to test for bacteria in drugs
After a lengthy review, the organization that sets manufacturing standards for drug makers will keep…
The WHO launched a voluntary Covid-19 product pool. What happens next?
After weeks of planning, the World Health Organization formally launched a voluntary pool to collect…
STAT Plus: Additional blood cancer responses seen with Allogene’s off-the-shelf CAR-T cells, updated study shows
Allogene on Friday released updated results from the first study of its off-the-shelf CAR-T cell…
STAT Plus: AstraZeneca study results could change treatment for certain early-stage lung cancer patients
In April, AstraZeneca halted a clinical trial of its genetically targeted lung cancer drug Tagrisso…
STAT Plus: Startup Spotlight: Going after immune regulators when they cause disease instead of prevent it
Q32 Bio has two targets in its sights: the two arms of the immune system….
STAT Plus: Experts push for a ‘seal of approval’ to improve the quality of medicines
Should there be a Good Housekeeping ‘seal of approval’ for prescription medicines? In a new…
STAT Plus: A pharma effort to work with European officials to develop new drugs is a “failure”
In a scathing report, a pair of non-governmental organizations accused the European pharmaceutical industry of…
Opinion: Biopharma companies are spreading misinformation — and taking advantage of it
As Covid-19 upends the world, people are putting their faith in the biopharma industry to…
STAT Plus: ‘One thing cancer patients don’t generally have is time’: New cancer research leader brings urgency to Sanofi
Peter Adamson joined Sanofi in late March, as the coronavirus pandemic surged around the world…
STAT Plus: Argenx antibody drug improves symptoms in patients with myasthenia gravis
Argenx, a Belgian drug maker, said Tuesday that its experimental medicine improved the symptoms of…
STAT Plus: Phlow CEO speaks out on criticism of his record, plans for a drug ingredient stockpile, and a huge government contract
Earlier this week, the U.S. government awarded a $354 million contract to a new public…
STAT Plus: Startup Spotlight: Aiming to speed precision cancer therapies to children
For some children with a certain type of brain tumor, treatment can mean surgery followed…
STAT Plus: Kadmon to seek FDA approval of drug targeting graft-versus-host disease following positive study outcome
Kadmon Holdings, the New York-based biotech, said Thursday that its experimental pill for chronic graft-versus-host…
STAT Plus: Moderna carries a big-boy market valuation now, so it shouldn’t act like a biotech penny stock
Some additional thoughts and comments on Moderna, its coronavirus vaccine, the stock’s valuation and Monday…
Opinion: Covid-19 has exposed the limits of the pharmaceutical market model
That so much hope is being pinned on remdesivir, the drug Gilead is testing for…
EMA urged to release full clinical trial data upon authorizing Covid-19 treatments
Amid a worldwide clamor for Covid-19 medicines and vaccines, the European Medicines Agency is being…
WHO embraces plan for Covid-19 intellectual property pool
In response to the global race to combat the Covid-19 pandemic, the World Health Organization…
The Trump administration outlines audacious plan to deliver ‘hundreds of millions’ of Covid-19 vaccine doses by end of 2020
WASHINGTON — The Trump administration on Friday rolled out a hyper-ambitious plan to develop and…
STAT Plus: Many pivotal drug studies don’t include data on race or ethnicity, analysis finds
Amid concerns that clinical trials do not adequately represent patient populations, a new analysis finds…
Opinion: Americans think the government should regulate profits from Covid-19 treatments. Be careful what you wish for
As the death toll from the novel coronavirus climbs toward 90,000, a new national survey…
Opinion: Gilead should ditch remdesivir and focus on its simpler and safer ancestor
In the midst of a pandemic like Covid-19, for which there are no FDA-approved drug…
STAT Plus: Amgen’s KRAS-blocking drug shows small improvement in colon cancer response
Amgen’s experimental KRAS-blocking drug is showing a modest improvement in response rates for patients with…
STAT Plus: Roche’s novel checkpoint inhibitor delivers mixed results in new lung cancer study
Roche on Wednesday said a two-drug combination that includes a novel but still experimental checkpoint-blocking…
STAT Plus: Some blood cancer patients see remission with Allogene’s off-the-shelf CAR-T cells, early data show
Allogene on Wednesday released the first data on tumor responses to its off-the-shelf CAR-T cell…
STAT Plus: ‘Good’ bacteria could help fight a common vaginal infection, new data show
Most companies in the microbiome space have focused on recurrent, deadly C. difficile bacterial infections….
French drug maker Genfit says NASH drug fails late-stage clinical trial
French drug maker Genfit said Monday that its lead drug, elafibranor, failed to improve outcomes…
Opinion: Acknowledging the public role in private drug development: lessons from remdesivir
The quest for vaccines and therapeutic treatments against Covid-19 shouldn’t be complicated or delayed by…
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The U.S. government contributed research to a Gilead remdesivir patent — but didn’t get credit
Two documents dating back to 2015 shed further light on the role the federal government…
STAT Plus: Dyne Therapeutics and three other startups got venture funding a year ago. Will it be enough to get them through Covid-19?
How a venture-backed startup gets its money is suddenly more fraught than it used to…
STAT Plus: Pharmalittle: Gilead looks to widen access to remdesivir; ousted BARDA head files whistleblower complaint
Good morning, everyone, and welcome to the middle of the week. Hard to tell, though,…
STAT Plus: Rebiotix unveils positive — but preliminary — data on its microbiome drug for C. diff infections
Rebiotix, one of a handful of major companies working on microbiome-based drugs, announced Wednesday that…
Gilead signals steps to widen global access to remdesivir for Covid-19 patients
Amid questions about access to remdesivir, its treatment for Covid-19, Gilead Sciences (GILD) says it…
STAT Plus: Akebia’s experimental pill meets anemia, heart-safety goals in two late-stage clinical trials
Akebia Therapeutics said Tuesday that its experimental anemia pill achieved the primary efficacy and heart-safety…
Efforts to beat back the coronavirus are critical. They’re also making clinical trials harder
In March, a team of Chinese scientists studying whether the antiviral remdesivir was effective against…
STAT Plus: Orphan drugs improve health — but aren’t priced cost-effectively, study finds
As regulators approve a growing number of orphan drugs, prices for these medicines, which treat small…
Lawmaker asks HHS to ensure Gilead’s remdesivir is affordable if U.S. taxpayers funded R&D
Now that preliminary trial results indicate an experimental Gilead Sciences (GILD) drug can successfully treat…
Doctors anticipate patient requests for experimental remdesivir before all the evidence comes in
Before Wednesday’s hopeful news about the experimental antiviral remdesivir broke, doctors treating patients hospitalized for…
Gilead’s remdesivir has seen success against the coronavirus. Now the company has to make enough to supply the world
In January, Gilead Sciences wasn’t manufacturing more than a few doses of its experimental antiviral…
STAT Plus: Watchdog scolds HHS for lacking a big-picture plan to incentivize antibiotic development
Amid growing anxiety over a lack of antibiotics, a new report from a Congressional watchdog…
STAT Plus: Biogen’s blockbuster rare disease drug could be in trouble
The success of Biogen’s spinal muscular atrophy treatment Spinraza has been among the few bright…
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STAT Plus: Patients, drug makers grapple with how to continue cancer trials during the coronavirus
The coronavirus pandemic has thrown a wrench into plans for hundreds of clinical trials seeking…
STAT Plus: ‘GI tract outside the body’ tests how well oral drugs are absorbed
When people swallow a pill, they expect the medicine to quickly reach the source of…
STAT Plus: New type of checkpoint inhibitor offers early promise against tumors, but will it last?
A new type of checkpoint inhibitor from an Israeli biotech company called Compugen is showing…