The Food and Drug Administration on Saturday issued an emergency authorization for a Covid-19 vaccine developed by Johnson & Johnson, the third vaccine to be cleared for use in the United States and the first that requires only one dose.
The vaccine, which has not yet been tested in children or adolescents, was cleared for use in adults aged 18 and older.
Like so many other Americans, we were green with envy as we watched football fans swarming the streets of Tampa Bay after the Buccaneers won the Super Bowl, and again when they clogged the parade route during the team’s victory flotilla a few days later.
We, too, wanted to yell and sing and chant and not wear masks and ignore social distancing in the face of a viral pandemic that has killed almost 2.5 million people worldwide and more than 500,000 in the U.S.
Riding a wave of pandemic-fueled momentum for virtual care, Cigna subsidiary Evernorth is acquiring telehealth provider MDLive, the companies announced Friday.
The news marks a significant strategic pivot for MDLive — which had at one point planned to go public at the start of the year — and reflects broader shifts in the virtual care landscape as the public stage for telehealth companies grows increasingly crowded. Cigna, a longtime investor in MDLive, will wrap the telehealth provider into Evernorth’s portfolio of health services, which already includes chronic care and pharmacy capabilities.
WASHINGTON — Biden administration officials on Friday warned of a “very concerning” uptick in Covid-19 cases this week, urging Americans not to let down their guard despite an ongoing vaccination campaign and case rates that are substantially lower than their peak last month.
“We may be done with the virus, but clearly the virus is not done with us,” Rochelle Walensky, the director of the Centers for Disease Control and Prevention, said during a White House press briefing. “I know people are tired and they want to get back to life, to normal, but we’re not there yet.”
In a tense exchange on Thursday during the Senate confirmation hearing of Dr. Rachel Levine, President Biden’s nominee for assistant secretary of health, Sen. Rand Paul exposed his lack of understanding about — or perhaps prejudice against — transgender youth.
After misrepresenting transgender health care as genital mutilation, Paul (R-Ky.), an ophthalmologist, asked Levine, an openly transgender pediatrician, whether minors should be able to request hormone therapy and gender-affirming surgery.
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 Spark Therapeutics, a Roche unit, (RHHBY) hired Cynthia Pussinen as chief technical officer. Previously, she worked at Honeywell International (HON), where she was global vice president and general manager, life sciences and specialty chemicals.
Good morning, one and all. Damian Garde here, filling in for Ed Silverman in the waning hours of a normal workweek made to feel that much longer by the truncated one that preceded it. The weather is slowly tilting toward the pleasant in at least this part of the world, an invitation to spend some time outdoors for the weekend hours not devoted to reloading vaccine appointment webpages. Until then, here as always are some tidbits to get your day started.
Sarepta Therapeutics won FDA approval for its third drug targeting Duchenne muscular dystrophy, STAT reports. The treatment, called Amondys 45, is for the roughly 8% of Duchenne patients whose disease is tied to a specific genetic mutation. Sarepta’s three approved medicines cover about 30% of patients with the disease. Amondys 45, like Sarepta’s other drugs, was based on its ability to produce a tiny amount of the muscle protein dystrophin, even though there is no established proof that more dystrophin improves muscle function or slows the progression of the disease.
Now it’s Johnson & Johnson’s turn.
A panel of outside experts is meeting Friday for a third time to consider whether the Food and Drug Administration ought to give an emergency use authorization for a Covid-19 vaccine, this one from J&J. And for a third time, STAT reporters will live-blog the advisory committee’s deliberations.
The Covid-19 pandemic has shown the damage that an uncontrolled infectious disease can cause society. It’s something experts have been warning about for decades, yet society was unprepared.
Antibiotic-resistant bacteria represent a similar risk. Starting with penicillin, antibiotics transformed the practice of medicine, making diseases like pneumonia curable and more complicated surgeries possible. But now an increasing number of bacteria are resistant to all the drugs available to treat them. Yet drug companies are not that interested in developing new antibiotics — largely because there has been little commercial incentive to do so. Some companies aiming to launch new antibiotics have even gone bankrupt.
For science, 2020 was a year like no other, as labs around the world shifted their focus to understanding and developing treatments and vaccines against Covid-19. Not surprisingly, research on the novel coronavirus dominates the bracket for this year’s STAT Madness, our annual competition in which readers choose the most important biomedical advance or discovery to emerge from U.S. labs in the past year.
Of the 64 entries selected — from nearly 130 submissions from universities and affiliated research institutions — 15 involve research on Covid. They include characterizing the immune response to the coronavirus; repurposing existing drugs as treatments; understanding why patients’ blood clots; devising tests using CRISPR as well as sewer water; and performing the preclinical work that led to the single-dose Johnson & Johnson vaccine, which is expected to be granted emergency authorization in the U.S. in coming days.
Opinion: Primary care practices could be the Biden administration’s secret weapon in the fight against Covid-19
For a small-town physician, being given a supply of the Covid-19 vaccine can make a world of difference.
In Cut Off, La., 30 of primary care physician Gary Birdsall’s patients have died from Covid-19. In his small rural community, they were neighbors and friends. So when a shipment of the Moderna vaccine arrived at his practice, it changed everything. As he described it to a reporter, the vaccine “put some degree of power back in my hands to prevent some of the illness I’m seeing.”
WASHINGTON — The humbling of New York Gov. Andrew Cuomo on pandemic policy has been spectacular and swift. Within a matter of days, one of America’s most trusted voices in the early days of the Covid-19 pandemic became a political pariah.
Outrage over Cuomo’s decisions — first, to require nursing homes to accept Covid-19-positive patients when New York’s hospitals were overflowing, and then, to hide data about deaths of nursing home residents — has engulfed Albany in recent weeks. Court orders, leaks, and investigations revealed that Cuomo dramatically and intentionally understated the pandemic’s toll on nursing home residents in New York.
With time running out for their medical residency decisions, some applicants say they’re taking Tulane off their list of choices after the dismissal of a residency program director who had filed a discrimination lawsuit.
“I’ve already gone through med school as a Black woman, so I know how bad it can get,” said Farrah-Amoy Fullerton, who applied to the pediatrics program at Tulane. “I already made the decision a while ago that I was not going to subject myself to that for the next three years for residency.”
File this under ‘Waste not, want not.’
In response to the cost of medicines, a fierce debate has broken out in recent years over ways to reduce the amount of unused liquids left in vials of infused or injectable cancer treatments and other therapies. One widely cited estimate suggested the U.S. health care system wasted $2.8 billion each year.
Why can’t kids get Covid-19 vaccines? Is there hope for biotech penny stocks? And when are feces medicine?
We discuss all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, pediatric cancer advocate Nancy Goodman joins us to discuss why she believes Covid-19 vaccine trials need to be sped up for teens and children. Then, Wall Street Journal reporter Greg Zuckerman calls in to explain the unlikely story behind Novavax, a former biotech penny stock now on the verge of making history. Finally, we embark on a lightning round, featuring quick takes on the confirmation process for a new health secretary and the future of therapeutic stool.
Sarepta wins new drug approval for patients with Duchenne muscular dystrophy, its third marketed treatment
The Food and Drug Administration on Thursday approved a new medicine from Sarepta Therapeutics that treats certain patients with Duchenne muscular dystrophy.
The new drug, called Amondys 45, is Sarepta’s third marketed treatment for the rare, inherited muscle-wasting disease. It will be used to treat the approximately 8% of patients with a confirmed mutation to the Duchenne gene that is amenable to exon 45 skipping.
Opinion: Discarded drugs: a wasteful and costly problem that requires whole-of-government approaches
Controlling the rising costs of pharmaceuticals, particularly those administered by physicians, has been a top health care priority for policymakers, with recent actions in both Congress and the executive branch. Reducing the waste from discarded drugs is a piece of the broader approach to drug affordability.
Since 2006, physician-administered drugs in Medicare Part B spending has grown each year at an estimated 8.1% per enrollee, twice as rapidly as outpatient drugs in Medicare Part D and nearly three times the spending rate for the nation overall. In addition to the growing costs, a significant volume of infused or injected drugs, largely for complex diseases such as cancer and rheumatoid arthritis, are discarded due to variable dosing and their distribution in single-use vials.
Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET.
Isolation. Job loss. Anxiety about getting sick. For all the disease and death that the pandemic has caused, it is also having a stark impact on people’s mental well-being.
STAT+: Pharmalittle: Moderna proceeds with a vaccine trial to combat Covid-19 variant; who will be the next FDA commish?
Top of the morning to you, and a fine one it is. Once again, clear blue skies and comfortable breezes are enveloping the Pharmalot campus on what is a relatively balmy start to the day. Hard to believe, but it appears that “sprinter” has finally arrived. What is sprinter? You know, that pivotal moment when winter blurs into spring. We hope we are not calling this prematurely, but we feel this deserves another cup of stimulation. Our choice today is coconut. Meanwhile, here are some tidbits. Hope your day goes well, and stay safe — wear a mask. …
Moderna (MRNA) is moving ahead with a modified version of its Covid-19 vaccine meant to protect against an emerging strain of the virus and plans to start a clinical trial as soon as regulators give a green light, STAT writes. Lab tests suggested the Moderna vaccine confers less protection against a variant known as B.1.351 than other strains. Pfizer (PFE) reported similar findings with its shot, and human trials conducted by Johnson & Johnson (JNJ) and Novavax (NVAX) also suggest vaccines designed for the original strain are less effective against B.1.351.
In a decision with broad implications for the pharmaceutical industry, a U.S. appeals court recently restricted wide-ranging patent claims for antibody treatments, a ruling legal experts say may force biologics makers to re-examine patent protections for their products.
In this instance, Amgen (AMGN) and Sanofi (SNY) were battling over the market for injectable cholesterol-lowering medicines called PCSK9 inhibitors. For the past several years, the companies have been locked in patent disputes, but earlier this month the appeals court decided that two Amgen patents for its Repatha cholesterol medication were invalid.