Biogen is selling its stake in a pharmaceutical joint venture with the South Korean conglomerate Samsung for $2.3 billion, the company said Thursday, bolstering the drugmaker’s balance sheet.
Under the agreement, Samsung Biologics is acquiring Biogen’s ownership in Samsung Bioepis, which manufactures off-patent versions of biologic medicines called biosimilars. Biogen will get $1 billion in cash once the deal closes, followed by $1.25 billion paid out over two years. The joint venture, founded in 2012, has six approved biosimilars and five more in development.
The U.S. International Trade Commission agreed to investigate whether two companies misappropriated trade secrets in connection with plans to eventually market a biosimilar version of Humira, a best-selling biologic medicine sold by AbbVie (ABBV) for treating rheumatoid arthritis and other ailments.
The decision follows a complaint filed last month by AbbVie, which is bracing for a clutch of biosimilar competitors next year and which hopes to thwart Alvotech and its partner, Teva Pharmaceuticals (TEVA), from selling a version of Humira even sooner. Alvotech is awaiting regulatory approval for its drug after pandemic travel restrictions delayed plant inspections by the Food and Drug Administration.
Who gets to be an “expert” on Covid-19? Are Americans entitled to drugs that don’t work? And how does the FDA deal with states’ rights?
We cover all that and more this week on “The Readout LOUD,” STAT’s biotech podcast. First, we discuss the FDA’s decision to halt the use of two Covid-19 antibodies that don’t work against Omicron — and the surprising backlash that ensued. Then, acting FDA commissioner Janet Woodcock joins us to dig into the agency’s move and discuss the steps for regulation of Covid drugs. We also go over the latest news in the life sciences, including some bad news for Gilead Sciences and a rare victory for a small biotech company.
Gov. Ron DeSantis of Florida has refused to say whether he’s received a booster shot. He’s suggested, misleadingly, that Covid-19 vaccines cause infertility. He hired a surgeon general who has questioned the data surrounding vaccines and called those who refuse to be immunized “brave.”
But when it comes to experimental Covid therapeutics, DeSantis and his government are all-in — even when outside researchers, the Food and Drug Administration, and the medicines’ own manufacturers say they don’t work.
STAT+: Pharmalittle: Biden administration used hospital funds to buy Covid vaccines and drugs; a cancer drug may help combat HIV
Good morning, everyone, and how are you today? There is a decidedly wintry feel to the sparkling sun and clear blue skies that are greeting us. The single digit display on our thermostat suggests we should don a sweater to go with that piping hot cup of stimulation that defines our daily ritual. Our choice today is bananas Foster, which is quickly becoming a favorite. As always, feel free to join us. In any event, time to get cracking. After all, there is much to be done. So here are some items of interest. Hope your day is simply smashing, and by all means, drop us a line if you run across something fascinating. We accept intriguing documents …
The Biden administration quietly took nearly $7 billion from a fund meant to help hospitals and clinics affected by the pandemic and used it to buy Covid-19 vaccines and therapeutics, STAT reports. The move is similar to a Trump administration decision to divert $10 billion from the same fund to Operation Warp Speed. Now, the hospital money, known as the Provider Relief Fund, has run dry, and has no new money left to allocate, according to the agency that administers it. Providers have only been able to submit requests for expenses incurred through March 2021 — before both the Delta and Omicron surges battered the health care system.
Opinion: Doctors were complicit in Holocaust atrocities. Current and future health care workers need to know that
The liberation of the concentration camp at Auschwitz on Jan. 27, 1945, revealed many horrors. Among them were the atrocities perpetrated by doctors who took ethics very seriously, albeit with an unusual code of ethics with the State as the “patient.”
When SS physician Fritz Klein was asked by a prisoner-physician how he reconciled his actions in concentration camps with his ethical obligations as a physician, he answered, “Out of respect for human life, I would remove a purulent appendix from a diseased body. The Jews are the purulent appendix in the body of Europe.”
Opinion: STAT+: Med tech companies that approach value-based care contracting wisely can earn first-mover advantage
The frequency and intensity of discussions around the transition from fee-for-service to value-based care continue to increase at the payer and provider level. Little has been said about how medical technology companies should navigate this coming change.
Into that vacuum has crept an abundance of misperceptions. Perhaps the most dangerous one is a belief that simply structuring the terms of contracts as performance and risk-share guarantees will lead to success.
Patchwork system for rationing a Covid drug sends immunocompromised patients on a ‘Hunger Games hunt’
The first thing to know about M. is that for her, there was no pre-Delta surge of optimism. She has multiple sclerosis. Every six months, she gets an infusion to destroy her B-cells-gone-haywire and slow the havoc they’re wreaking on her spinal cord and brain. Those are the same B cells that would normally unleash an army of protective antibodies in response to a vaccine. Without them, her best bet to survive Covid was to avoid it — one long, anxious lockdown, as if nothing had changed since March 2020.
Then, right around Christmas, something did change. There was a new glimmer of possibility — a prophylactic treatment called Evusheld, which might give her six months’ worth of the helpful antibodies her own body couldn’t make. The trouble was getting some. An estimated 7 million Americans with impaired immunity were eligible, but the federal government initially bought enough for only a tenth of them — and then, after an outcry, increased the total order to 1.2 million courses.
STAT+: Out with FaceTime, in with one-stop-shops: Hospitals scrap telehealth stopgaps for more streamlined platforms
In the early weeks of 2020, thousands of Cleveland Clinic doctors were scrambling to see patients on whatever software and devices they already had at home — and at the time, smartphone apps like FaceTime and Google Duo had to cut it.
It was a frenzied, almost overnight transition to virtual care spurred by emergency federal waivers letting doctors use less secure apps designed for consumers to conduct telehealth appointments. But two years into the pandemic, Cleveland Clinic and other large health systems are ditching those stopgap fixes in favor of fewer but more complex, expensive, and customizable tools that can toggle between video visits, lab results and scheduling — and host hundreds of thousands of video and audio visits each year.
STAT+: Michigan attorney general pursues investigation into Lilly’s ‘grossly’ excessive insulin prices
As anger grows over the cost of prescription medicines, the Michigan Attorney General is seeking court approval to launch an investigation into Eli Lilly (LLY) over insulin drug prices that the state says are having “devastating impact” on consumers.
The drug maker was accused of charging “grossly” excessive prices for three different insulin products — Lispro, Humalog and Basaglar – that have forced some patients to ration or forego their insulin, restrict their diets, or buy less-effective alternatives. “These practices have caused serious disability and even death in some patients,” the state wrote in court documents.
Hospitals are denying transplants for patients who aren’t vaccinated against Covid, with backing from ethicists
A Boston hospital’s denial of a heart transplant to a man who is unvaccinated for Covid-19 has generated national attention, but experts say mandating vaccines is in keeping with other long-standing requirements that patients have to meet to receive an organ — including getting other shots.
In this case, Brigham and Women’s Hospital dropped a 31-year-old man named DJ Ferguson from its transplant waitlist, his family said. Ferguson was concerned about side effects and the speed with which the vaccines were developed, his mother told WCVB.
Antiretroviral therapy, the standard treatment for HIV, can remove any trace of the virus from the blood, but a hidden reservoir of HIV persists in patients who are in treatment. That means patients are never truly cured and need to be on HIV drugs for the rest of their lives.
Researchers have yet to discover a way to eliminate the virus in its latent stage, but new, early-stage research suggests a landmark cancer drug — pembrolizumab, also known as Keytruda — may be able to help. In a study published Wednesday in Science Translational Medicine, researchers looked at 32 patients that had both cancer and HIV and found that pembrolizumab, which revives the immune system and encourages it to attack tumors, also has the ability to flush HIV out of its hiding spot in immune cells.
WASHINGTON — The Biden administration quietly took nearly $7 billion from a fund meant to help hospitals and clinics affected by the pandemic and used it to buy Covid-19 vaccines and therapeutics, according to a document obtained by STAT.
The move is similar to the Trump administration’s decision to divert $10 billion from the same fund to Operation Warp Speed, which STAT reported exclusively in March.
File this under ‘How curious.’
After generic versions of a key hepatitis B treatment debuted in 2014, they helped patients save money over the next few years. Yet at the same time, the average out-of-pocket spending on those generics actually rose, even though nearly a dozen copycat versions were available, suggesting competition failed to work sufficiently.
STAT+: Pharmalittle: Gilead faces partial clinical hold on blood cancer drug; Rhode Island agrees to opioid deal with wholesalers
Hello, everyone, and how are you this fine, sunny morning? The middle of the week has arrived, as you may know, so why not celebrate with a delicious cup of stimulation? After all, you made it this far, which is a likely sign of surviving another few days. And of course, no prescription is required, which is a good thing. Our choice today, for those keeping track, is butter pecan. And while you drink up, you can peruse some of the tidbits we have assembled to help you start the day. Hope you conquer the world and, as always, do keep in touch. …
Rhode Island reversed course and will now support a $21 billion nationwide settlement it originally declined to back resolving lawsuits alleging that three large wholesalers — AmerisourceBergen (ABC), McKesson (MCK), and Cardinal Health (CAH) — fueled the deadly U.S. opioid crisis, Reuters writes. This marks the latest instance of a holdout state opting into the settlement with the distributors. How much the companies ultimately must pay and how much outstanding litigation they will face depends on state and local government participation. The number of states that have not agreed to settle with some or all of the four companies has dwindled from nine in September to five.
SPACs aren’t all fun and games, until they are.
Akili Interactive, which makes a video game that treats attention problems in young people, announced plans Wednesday to go public in a merger with Social Capital Suvretta Holdings Corp, a special purpose acquisition company run by venture capitalist and former Facebook executive Chamath Palihapitiya. The deal could value the company up to about $1 billion after investment.
STAT+: Studies of Gilead blood cancer drug interrupted by emerging safety issue, clouding its future
The development of a blood cancer drug acquired by Gilead Sciences — the centerpiece of a $5 billion deal — has been interrupted by a potentially serious safety issue.
On Tuesday, the Food and Drug Administration placed a partial clinical hold on five clinical trials investigating the combination of the Gilead drug, called magrolimab, with another commonly used blood cancer medicine. The agency stepped in because of an “apparent imbalance in investigator-reported suspected unexpected serious adverse reactions” between study arms in one or more of the trials, Gilead said in a statement.
Two years into the pandemic and in the midst of the latest hospital staffing crisis, nurses have finally gotten the country’s attention when it comes to burnout and attrition within the country’s most trusted profession. It’s an important shift, because nursing is in trouble.
This week on the “First Opinion Podcast,” nurse and researcher Jane Muir describes some of the issues that are nudging more and more nurses to trade staff positions for jobs as travel nurses, or to leave nursing entirely, and offers ways to retain staff nurses. She says hospital systems need to put cash toward the nurses who make those systems so profitable, and tie the health and well-being of their nursing staffs’ often-invisible work (at least to administrators) to hospitals’ balance sheets, along with their accreditation status and government reimbursement rates.
As a Black woman with long, poofy hair, I was delighted to see Oregon join California and 11 other states that have passed laws against hair discrimination. In those states, workplaces and educational institutions can no longer legally discriminate against Black people for their hairstyles and hair texture.
A little-discussed aspect of hair discrimination is how it can affect medical care, something I began to seriously contemplate during the first year of my psychiatry residency.