Results from a late-stage clinical trial released late Friday by the drug maker CytoDyn showed its experimental antibody leronlimab failed to improve the survival of patients hospitalized with severe, life-threatening cases of Covid-19.
Instead of acknowledging the negative outcome of the Phase 3 clinical trial, however, CytoDyn issued two statements over the weekend claiming results spun from a small slice of patients were positive and warranted approval as a treatment for Covid-19.
Vaccination, particularly for the most vulnerable Americans, is the surest way for us to overcome the Covid-19 crisis. As physicians, we celebrate the light at the end of the tunnel, in large part due to Operation Warp Speed. But as members of Congress, we are becoming increasingly concerned that federal bureaucracy continues to stand in the way of rapid, widespread administration of Covid-19 vaccines.
The nation has gained a tremendous amount of knowledge about Covid-19 over the past year. Similarly, over the past few weeks, the scientific community has published encouraging analyses about the vaccines that are playing a starring role in leading us out of this crisis. Mountains of real-world evidence are showing that the two mRNA vaccines authorized by the FDA — the first made by Pfizer and BioNTech, the other by Moderna, both of which are supposed to be administered as a two-dose regimen — will provide substantial protection against Covid-19 even after only one dose.
WASHINGTON (AP) — An exhausted Senate narrowly approved a $1.9 trillion Covid-19 relief bill Saturday as President Joe Biden and his Democratic allies notched a victory they called crucial for hoisting the country out of the pandemic and economic doldrums.
After laboring all night on a mountain of amendments — nearly all from Republicans and rejected — bleary-eyed senators approved the sprawling package on a 50-49 party-line vote. That sets up final congressional approval by the House next week so lawmakers can whisk it to Biden for his signature.
The Food and Drug Administration on Friday issued an emergency authorization for a new test to detect Covid-19 infections — one that stands apart from the hundreds already authorized.
Unlike tests that detect bits of SARS-CoV-2 or antibodies to it, the new test, called T-Detect COVID, looks for signals of past infections in the body’s adaptive immune system — in particular, the T cells that help the body remember what its viral enemies look like. Developed by Seattle-based Adaptive Biotechnologies, it is the first test of its kind.
At least four founding members of Time’s Up Healthcare resigned Thursday from the organization following a lawsuit that suggests two other founders did not respond appropriately to reports of sexual harassment and assault in their separate jobs at Oregon Health and Science University.
Both Esther Choo and Laura Stadum are mentioned in a legal complaint filed in February in an Oregon federal court by an anonymous employee of the Veterans Affairs hospital, in which the employee alleges that a resident who is well-known on Twitter and TikTok harassed her, sending her “sexually-charged social media messages” and once pushed his erect penis against her body.
Three congressional lawmakers are examining the extent to which pharmaceutical wholesalers and a leading drug maker may use a provision in the Covid-19 relief bill enacted last year to boost tax breaks for legal costs related to their roles in the opioid crisis.
The inquiry was sparked by Cardinal Health (CAH), which recently disclosed plans to collect a $974 million refund as a net operating loss carryback. This accounting exercise allows a company to claim an immediate refund of taxes previously paid by reducing taxes owed in the past. This break was included in the CARES Act bailout package last year as a way to help companies struggling during the pandemic.
One year after an epidemiologist, a preparedness expert, and an infectious disease journalist presciently warned about the disruptions to come from the then-burgeoning Covid-19 pandemic, the same group cautioned on Friday that, despite recent vaccination successes, the world is not yet through the crisis, and it should prepare now for the twists the coronavirus could throw our way in the coming months.
“What is the end goal here?” said the epidemiologist, Michael Mina of Harvard’s T.H. Chan School of Public Health. “Is it to get to zero? Is it to stop hospitalizations and deaths? To just get them to an OK number? I don’t think society has agreed yet on what the goal is. But the one very clear thing is this isn’t done.”
In its latest bid to ensure competition among drug makers, the European Commission has opened a formal investigation into whether Teva Pharmaceutical (TEVA) illegally prevented rival companies from introducing versions of a top-selling medicine.
The probe is focused on two issues. The first is whether Teva used various patent maneuvers to thwart generic manufacturers from being able to market copycat versions of the Copaxone multiple sclerosis treatment. The EC also wants to determine if the drug maker ran a campaign directed at hospitals and doctors to create “false perceptions” of similar multiple sclerosis medicines.
Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.
And here is our regular feature in which we highlight a different person each week. This time around, we note that Novartis (NVS) anmed Thomas Kendris as interim global head of litigation and U.S. president after Shannon Thyme Klinger resigned to take another job.
STAT+: Pharmalittle: Serum CEO warns of shortage of vaccine components; EU to extend Covid-19 export scheme
And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our modest agenda includes catching up on our reading, promenading with the official mascot, and finding fun food for our hard-working short person. And what about you? This may be a good time to get vaccinated, assuming supplies are available. You could get a jump on spring cleaning. Or bolster the economy by arranging for restaurant takeout. Well, whatever you do, have a grand time. But be safe — wear a mask. Enjoy, and see you soon. …
The head of the Serum Institute of India, the world’s biggest vaccine maker, said manufacturers of Covid-19 shots face a global shortage of the raw materials needed to churn out the inoculations, Bloomberg News reports. Adar Poonawalla told a World Bank panel that a U.S. law blocking the export of certain key items, including bags and filters, will likely cause serious bottlenecks. Soumya Swaminathan from the World Health Organization added that there were shortfalls of vials, glass, plastic, and stoppers required by those companies.
The bubonic plague — also known as the Black Death — killed as many as 200 million people in the mid-14th century, about one-third of the population of Europe. It was the deadliest epidemic in history, yet it gave birth to public health initiatives that survive today, including quarantines and checkpoints to stop the spread of disease.
In the wake of World War II, a wave of international collaboration created the World Health Organization. The HIV/AIDS epidemic spawned a new era of urgency and activism for international health efforts.
The Food and Drug Administration’s recent approval of Johnson & Johnson’s Covid-19 vaccine for emergency use in the United States is wonderful and welcome news. Its addition dramatically increases the likelihood that all adults will have a chance to be vaccinated before this summer — but only if people are willing to accept any of the three available vaccines.
That will happen only if people trust that the different vaccines are being distributed fairly.
Earlier this year, amid the increasingly bruising debate over Biogen’s controversial treatment for Alzheimer’s disease, Eli Lilly issued a six-paragraph press release extolling the promise of an under-the-radar therapy of its own — one that, if effective, would seem to support Biogen’s claims as well. Now the world is about to see detailed data that will illuminate whether Lilly’s work offers reason for hope after years of frustration — or more equivocal evidence in the search for a treatment to slow the mental decline that marks Alzheimer’s.
Lilly will present the results of a small, Phase 2 study on its drug, donanemab, on March 13 at a virtual conference of Alzheimer’s researchers. Lilly said in January that the intravenous drug met its primary goal with a 32% improvement in cognition and function compared to placebo, a statistically significant difference, but researchers are reserving judgement until the company reveals key study details.
STAT+: ‘We’re only going to cure diseases if we understand them’: Whitehead director advocates for basic science
Ruth Lehmann became director of the Whitehead Institute for Biomedical Research in July 2020. That juncture was deep enough into the pandemic for the research hub to be gradually reopening after a March 20 shutdown, but the center affiliated with nearby Massachusetts Institute of Technology is still adapting to life with Covid-19. The institute has improved air circulation, made entrances hands-free, added regular coronavirus testing for employees, and modified the cafeteria for in-house “takeout” meals. About 80% of scientists have returned to their labs to work in socially distanced shifts, administrative staff mostly work from home, and Lehmann spends much of her time in her institute office on Zoom calls.
A noted cell biologist who moved her lab from New York University to Cambridge, Mass., Lehmann promotes basic science as the driving force behind the extraordinary advances leading to rapidly developed Covid-19 vaccines. She also laments the toll the pandemic has taken on women in science. In a conversation with STAT, Lehmann charts the institute’s way forward, explains her own science, and shares two things people might not know about the Whitehead. This interview has been condensed and lightly edited.
Can pharma get along post-pandemic? How will we know when the Covid-19 crisis is over? And is it OK to feel optimistic?
We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we discuss Merck’s decision to help Johnson & Johnson manufacture vaccine doses and whether it’ll be a turning point for the drug industry or a relic of Covid-19 history. Then, as we near the one-year anniversary of the pandemic, STAT’s Andrew Joseph joins us to explain what experts think is in store in the months and years to come. Finally, Ashish Jha, dean of Brown University’s School of Public Health, joins us to explain why he’s optimistic about summer 2021.
STAT+: Physician and patients may prefer brand-name drugs, but they cost Medicare Part D a lot of money
Generic drugs may remain lower-cost alternatives to brand-name medicines, but the Medicare Part D program could have saved roughly $1.7 billion in 2017 if doctors and patients had actively opted for these copycat treatments, a new study finds.
More specifically, the program would have saved $977 million that year if generics had been substituted for all of the brand-name medicines requested by prescribers. And if Medicare patients had sought generics instead of brand-name drugs, Medicare Part D would have saved another $673 million, according to the study published in JAMA Network Open.
Amgen said Thursday it will purchase Five Prime Therapeutics for $1.9 billion to obtain a potential treatment for gastric cancer, a move that will also expand the biotech giant’s focus in Asia.
The deal represents a major victory for Five Prime, which traded as low as $2.17 last March. The company’s stock jumped in November, when key results from a study of its gastric cancer drug, bemarituzumab, were released, and have continued to rise since.
STAT+: Pharmalittle: Novartis to help make CureVac Covid-19 vaccine; U.K. to speed vaccine approvals for Covid-19 variants
Top of the morning to you. Gray skies are hovering over the Pharmalot campus right now, but our spirits remain sunny, nonetheless. Why? We will trot out a bit of insight from the Morning Mayor, who would say, “Every new day should be unwrapped like a precious gift.” To celebrate the notion, we are brewing still more cups of stimulation and invite you to join us. Our choice today, for those tracking this sort of thing, is … mountain blueberry. Meanwhile, here are a few items of interest. We hope your journey progresses nicely today and that you remain safe — remember, wear a mask….
Novartis (NVS) will help manufacture a Covid-19 vaccine that CureVac (CVAC) is developing, the latest drug maker tie-up aimed at accelerating production of shots, The Wall Street Journal notes. The two-dose vaccine is in late-stage testing and results could come as soon as next month. Novartis will upgrade a plant in Kundl, Austria, so it can help make up to 50 million doses of the vaccine this year and up to 200 million doses next year. Production is expected to begin in the second quarter, and delivery of key components in the summer.
Kronos Bio said Thursday that it had reached an agreement with the Food and Drug Administration for a unique, late-stage clinical trial that will accelerate the development — and potentially the approval — of its drug for patients with a genetically defined type of leukemia.
To demonstrate the efficacy of the drug, called entospletinib, Kronos will use highly sensitive sequencing tests to confirm undetectable levels of leukemic cells in patients. Achieving a negative finding for “measurable residual disease” is associated with longer remission and improved survival.
Eli Lilly said Thursday that a study showed its experimental diabetes drug, tirzepatide, reduced patients’ blood sugar and body weight more than a rival medicine, Novo Nordisk’s Ozempic.
Investors had been nervously awaiting the result, which was reported in a press release.