Fibrogen was expecting the Food and Drug Administration to complete a review of its experimental anemia pill and render an approval decision by March 20. But in a surprising — and concerning — move announced Monday evening, the FDA has instead decided to convene a meeting of outside experts to review the drug’s clinical data.
The scheduling of the advisory panel this late in the review process is unusual and will delay the approval of the oral drug, called roxadustat, Fibrogen said Monday.
STAT+: A nascent state effort would tax drug makers for not providing clinical evidence for price hikes
In a bid to control the cost of medicines, lawmakers in two states — Hawaii and Washington — recently introduced bills that would tax drug makers for raising prices without providing clinical evidence to justify the increases.
Although the bills failed to gain traction and would have to be reintroduced, the idea is likely to irk the pharmaceutical industry. As envisioned, drug makers would face penalties worth 80% of the difference between the sales generated by its medicine in each state and the revenue the drug would have been generated if the company had maintained the list price from the previous calendar year, adjusted for inflation.
The New Mexico attorney general has filed a lawsuit against Gilead Sciences (GILD) and two other major drug makers for allegedly conspiring to block competition to several different HIV medicines, which ultimately caused the state to spend millions of dollars for “excessively overpriced” treatments.
Specifically, the lawsuit details a complicated scheme in which Gilead “deliberately and deceitfully” delayed generic competition for its widely used HIV medicines for several years by, among other things, reaching purportedly anticompetitive settlements to patent litigation with Bristol Myers Squibb (BMY) and Teva Pharmaceuticals (TEVA), which is one of the world’s largest purveyors of generic drugs.
Babies born to people evicted during pregnancy are more likely to have lower birth weights and be born earlier or prematurely than those whose parents were evicted at other times, according to new research.
“It’s sort of this intergenerational transmission of disadvantage,” said Gracie Himmelstein, a Princeton researcher and author of the study, published in JAMA Pediatrics. Birth outcomes can serve as predictive measures not just for infant mortality, but for a person’s entire life, according to Himmelstein.
STAT+: Pharmalittle: J&J Covid-19 vaccine supply will be uneven; pandemic ushers in a ‘golden age of vaccinology’
Good morning, everyone, and welcome to another working week. We hope the weekend respite — which was extended, in our case — was somehow relaxing and invigorating, since the usual weekday routine has predictably returned. After all, the world keeps spinning. With this in mind, why not have a cup of stimulation and give it a push? Our choice today is vanilla caramel cream. Please feel free to join us. Meanwhile, here are a few items of interest to help you get going. We hope your day is productive and peaceful. …
Health care providers will begin receiving the first 3.9 million doses of the newly authorized Johnson & Johnson (JNJ) Covid-19 vaccine as early as Tuesday morning, though supply will be uneven in the coming weeks, STAT explains, citing senior Biden administration officials. The first shipments account for the entirety of J&J’s current inventory. Officials expect another 16 million doses to be available by the end of March, though J&J told the federal government that the doses will be delivered mostly toward the second half of the month.
The first round of voting begins Monday, March 1 at 6 a.m. EDT and is open until Sunday, March 7 at 11:59 p.m. EDT.
The Covid-19 pandemic is teaching us many tragic lessons along with some instructive ones, like the importance of adding patients’ diagnoses to their prescriptions. An example from 2020 shows why.
In the spring and summer of 2020, there was a dramatic increase in the number of prescriptions written for hydroxychloroquine, a proven therapy for malaria, lupus, and rheumatoid arthritis that was being hyped as a treatment for Covid-19. But it is difficult to determine the reason for the spike in prescribing because the data shed no light on why the drug was prescribed. That’s because doctors are not required to include this critical information on prescriptions.
STAT+: Janet Woodcock revolutionized the way the FDA reviews cancer drugs, inspiring her supporters and raising concerns for detractors
WASHINGTON — In 2000, the Food and Drug Administration approved just three cancer drugs. Last year, even with the agency laser-focused on the coronavirus pandemic, much of its staff teleworking, the agency still approved a record-breaking 17 different cancer therapies — more than in any other category.
That’s the legacy of FDA drug center chief Janet Woodcock.
WASHINGTON — Health care providers will begin receiving the first 3.9 million doses of Johnson & Johnson’s newly authorized Covid-19 vaccine as early as Tuesday morning, though supply will be uneven in the coming weeks, senior Biden administration officials said.
The first shipments account for the entirety of J&J’s current inventory. Officials expect another 16 million doses to be available by the end of March, though J&J told the federal government that the doses will be delivered mostly toward the second half of the month.
I have long thought that there are three types of physician.
The first is fascinated by the intricacy and complexity of biomedical science. The second finds inspiration in the personal relationship between doctor and patient. The third is committed to the broader context of health, to social justice and to making the world a better place.
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.