The stem cells were no more than a week old when scientists moved them from their slick-walled plastic wells into ones lined with a thin layer of human endometrial tissue. But in that time, the cells had multiplied and transformed, organizing themselves into semi-hollow spheres. Per the instructions of the chemical cocktail in which they’d been steeping, they were trying to turn into embryos.
Video cameras captured what happened next: The balls of cells rotated until they were cavity-side-up, before finally touching down and grabbing onto the endometrial layer, a cellular proxy for a human uterus. Days later, when the scientists dipped paper test strips into the wells, pink lines appeared. Their Petri dishes were pregnant.
STAT+: Pharmalittle: Glaxo and Vir drug appears to work against Omicron; employees sue Bristol Myers over vaccine mandate
Rise and shine, another busy day is on the way. However, this is also shaping up as a beautiful day, given the clear and sunny skies — and delicious breezes — enveloping the Pharmalot campus this morning. This calls for celebration with a cup of stimulation, and we are opening a new package of maple bourbon for the occasion. Winter, after all, is nearly upon us. What is upon us right now, however, is our ever-growing to-do list. Sound familiar? So… here are some items of interest. Have a great day, everyone. …
AstraZeneca (AZN) is dropping plans to test its Covid-19 vaccine as a booster in the U.S., Bloomberg News writes, citing a letter sent to participants in the clinical trial that urged volunteers to seek a third dose elsewhere. After discussions with the U.S. government, it became clear that the drug maker was unlikely to pursue plans to assess a third dose of its vaccine, according to the letter sent by New York’s Montefiore Medical Center to trial participants. AstraZeneca was one of the first vaccine developers out of the gate, but has yet to win clearance to sell the shot in the U.S. after facing questions about its clinical trial results and side effects.
WASHINGTON — President Biden will announce a new plan this afternoon for combating the Omicron variant of the coronavirus. The plan includes a new campaign to increase uptake of booster shots, new policies meant to provide Americans with free at-home coronavirus tests, and more stringent policies on international travel.
Public health officials still don’t know much about the Omicron variant, including whether it causes milder symptoms than other forms of the coronavirus, or whether it is more transmissible than other variants. The first case of the Omicron variant detected in the United States was announced by U.S. health officials on Wednesday Dec. 1.
In mid-November, a federal judicial panel assigned the Cincinnati-based United States Court of Appeals for the Sixth Circuit the immense task of overseeing legal challenges to the workplace vaccination mandate instituted by the federal Occupational Safety and Health Administration, now pending in 12 of the 13 circuits.
Before the Sixth Circuit was randomly chosen for this task, the New Orleans-based Fifth Circuit preemptively put a hold on the mandate, issuing an opinion that bitingly characterized OSHA’s emergency temporary standard as “staggeringly overbroad.”
After his second hospitalization for acute Covid-19, Tony Marks expected to get better. Then pain invaded the 54-year-old software executive’s arms and legs. At first, he felt like he was covered by deep bruises, although nothing was visible on his skin. These days, he told me, he feels like he’s being beaten repeatedly with a baseball bat.
Pain is increasingly being recognized as a key feature of what is commonly called long Covid, in which symptoms persist after the acute phase of the viral infection ends.
STAT+: Artificial intelligence is making a pitch to transform radiology. Will it pay off for hospitals?
For radiologists working today, the specter of artificial intelligence is inescapable.
In the past year, venture capitalists have continued to invest significantly in startups developing AI for medical image analysis and support, with some groups projecting a $20 billion market by 2031. But despite the proliferation of research and investment, AI products are still a hard sell for many radiology practices — even those at academic centers leading clinical research into deep learning. The tools are still in the middle of the hype cycle for any new technology: Inflated expectations are giving way to skepticism and barriers to adoption.
When Covid-19 variants arise, the accepted wisdom is that the constellation of mutations they contain developed in an immunocompromised person who contracted the virus and couldn’t shake the infection. But some scientists have an alternative theory for where the latest variant of concern, Omicron, may have acquired the unusual mutations that stud its spike protein.
They speculate the virus could have evolved in another animal species.
By the time cancer is discovered, it’s often too late to change its course. Close to half of cancers will already have spread, making death — whether within months, five years, or 10 years — a near certainty.
Mammograms, colonoscopies, and other cancer screenings may have caught some. But medicine doesn’t screen for many cancers — though in the future, it’s likely we will be able to with a simple blood draw.
Amid a closely watched legal battle, Amgen (AMGN) has joined the growing ranks of major drug makers curtailing the discounts offered through a federal program for safety-net hospitals and clinics.
As of Jan. 3, 2022, the company will no longer offer discounts to contract pharmacies used by hospitals and clinics that serve low-income populations and purchase medicines under the 340B Drug Discount Program, according to a letter sent by Amgen. The program requires drug makers to offer discounts that are typically estimated to be 25% to 50% — but could be much higher — on all outpatient drugs.
U.S. health officials on Wednesday reported the country’s first case of the Omicron variant of the coronavirus, in a person in California.
The Covid-19 case was identified by the California and San Francisco health departments in a person who had traveled to South Africa and returned on Nov. 22, the Centers for Disease Control and Prevention said in a release. The individual, who was fully vaccinated and had mild symptoms that are improving, has been isolating since testing positive. All close contacts have been contacted and have tested negative, the CDC said.
STAT+: Pharmalittle: Merck Covid pill squeaks past FDA panel; analysis explores whether insurers give ‘fair access’ to drugs
Top of the morning to you, and a fine one it is. A shiny sun and clear skies are enveloping the Pharmalot campus, where the official mascot is contentedly snoozing in a corner and street life is buzzing nearby. As for us, we are engaged in our usual ritual of brewing cups of stimulation, which we need more than ever since we have some upcoming chats with public radio types. Wish us luck. The flavor today, by the way, is glazed doughnut. Yum. Meanwhile, here are some tidbits to get you going. Hope your day is successful and you conquer the world. …
A panel of experts convened by the U.S. Food and Drug Administration voted by a slim margin to recommend the agency authorize the Covid treatment developed by Merck (MRK) and Ridgeback Biotherapeutics, after a vigorous debate about the risks and benefits of the first oral drug to combat the coronavirus, STAT writes. The panel voted 13-10 that the pill, called molnupiravir, should be authorized, although members expressed concerns that, if used in pregnancy it could cause birth defects. Discussions frequently turned to whether or not panelists trusted the effectiveness data on the drug, even when they were talking about other topics.
Do large health insurers in the U.S. provide “fair access” to prescription medicines?
The answer to that question is nettlesome and elusive, at least according to a new analysis.
STAT+: In a medical first, Vertex drug successfully targets the underlying cause of a genetic kidney disease
An experimental pill from Vertex Pharmaceuticals reduced levels of a damaging urine protein by nearly half in a small clinical trial — encouraging evidence that a novel medicine can arrest the underlying genetic cause of a chronic kidney disease that progresses rapidly to kidney failure.
Vertex called the mid-stage study results “unprecedented” and said it was working quickly to advance the drug, called VX-147, into a pivotal clinical trial, pending discussions with regulators.
STAT+: Socially responsible investor coalitions push greater access to medicines in shareholder proposals
Amid controversy over equitable distribution of Covid-19 vaccines, a large coalition of socially minded investor groups has filed shareholder proposals urging large drug makers to take various steps that could ultimately widen access to their medicines in the U.S. and elsewhere.
The effort reflects ongoing frustration with the pharmaceutical industry over business practices that have often made it difficult for patients to obtain treatments, according to Meg Jones-Monteiro, program director for health equity at the Interfaith Center on Corporate Responsibility, a 300-member organization with combined assets of over $4 trillion.
It can be hard to fathom that anyone other than you might own your information. But they do. Everything from what’s in your electronic medical record to the average jogging speed recorded on an app may be someone else’s property.
For a profit, the magic is in the aggregate. Innumerable hospitals, corporations, and apps are tracking their patients and users. But that information is worth more than money. On an individual scale, it’s valuable information that paints a full picture of health for individuals and their health care providers.
Faith was the first child I lost to HIV.
I can still see her, sitting next to her mother on a rusting metal bed in the ward of the hospital in Kenya where I was working as a pediatrician in 2004. Her mother, Rose, is pleased that they were able to reach the referral hospital where I worked. She thinks that if there is anywhere to have hope, it is here.
“I am really sorry to reach out like this, David, but I’m worried about my brother. I think he has AIDS.”
I froze when I heard those words a few weeks ago. One reason was because Cheryl was 11 years old the last time I heard her voice; she’s 40 now. The other was because I know from my training as a physician in New York City in the 1990s that, while HIV has become a manageable disease for some people, many others still die from complications of AIDS.
WASHINGTON — Democrats have made big promises to tackle racial inequities across society, including in health care, since protests for racial justice swept the nation in 2020.
Until recently, it wasn’t clear how either lawmakers or the Biden administration would deliver on those goals — but some of the first concrete steps are now taking shape in the new spending plan Democrats are moving.
The emergence of a new Covid-19 variant with a startlingly large constellation of mutations has countries around the world sounding alarms. While the concerns are understandable, experts in immunology say people need to remember a critical fact: Two years and 8 billion vaccine doses into the pandemic, many immune systems are no longer blank slates when it comes to SARS-CoV-2.
The new SARS-2 variant, known as Omicron, may more easily sidestep some of the immunity of some vaccinated and previously infected people. But there’s good reason to think people who already have some immune protections may avoid the worst of what Covid infections can do to immunologically naïve people.