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STAT Plus: Biogen-Eisai partnership may be hitting a rough patch following Alzheimer’s drug blowup

Fri, 03/22/2019 - 13:12

A rift may have opened in the Alzheimer’s disease partnership between Biogen (BIIB) and its Japanese pharma partner Eisai following the high-profile and costly failure of their jointly developed drug aducanumab.

Eisai said Friday that it intends to push ahead with the development of a second Alzheimer’s drug, called BAN2401, also part of the Biogen partnership. A Phase 3 clinical trial of BAN2401 targeting the enrollment of 1,500 patients with early Alzheimer’s disease has been initiated, Eisai said.

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STAT Plus: Kentucky probes pharmacy benefit managers for allegedly overcharging state Medicaid

Fri, 03/22/2019 - 11:23

The Kentucky Attorney General has begun a probe into allegations that pharmacy benefit managers overcharged the state Medicaid program and discriminated against independent pharmacies.

The move follows a recent report showing PBMs appear to have profited from spread pricing, which refers to the fees these companies pay pharmacies and then bill back to state Medicaid programs. Last year, PBMs were paid $858 million, of which they kept $123.5 million, or 13 percent. This was up from 9.4 percent in 2017, according to the report by the Kentucky Cabinet for Health and Family Services.

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STAT Plus: J&J’s new esketamine drug for depression may solve an unmet need, but may not be cost-effective

Fri, 03/22/2019 - 10:06

The first major depression treatment to hit the U.S. market in decades may be a new option for patients who fail to respond to existing therapies, but a preliminary analysis shows the price of the medicine would have to be shaved by 25 percent in order to be cost effective.

Known as esketamine and marketed as Spravato, the nasal spray was developed by Johnson & Johnson (JNJ), which set a list price of $590 to $885 per treatment session, depending on dosing and number of sessions, which can vary by patient. The initial month of therapy can cost from $4,720 to $6,785, while subsequent treatment can cost $2,360 to $3,540. Put another way, the annual tab might run from $33,000 to about $49,200.

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STAT Plus: Up and down the ladder: The latest comings and goings

Fri, 03/22/2019 - 07:16

Hired someone new and exciting? Promoting 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

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STAT Plus: Pharmalittle: NAFTA deal may hinge on patent protections for drugs; House committee goes after Sacklers

Fri, 03/22/2019 - 06:21

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 agenda is exceedingly modest, however. We plan to hang with one of our short people, catch up on some reading, and check in on the Pharmalot ancestors. And what about you? Spring is now — finally — here, so you can start cleaning out your castle, manicuring the grounds, and, hopefully, enjoy some time in the great outdoors. Speaking of which, perhaps you want to check on the extent to which those of you situated near certain bodies of water may be affected by climate change, assuming you believe in that sort of thing. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon. …

President Trump’s ability to get his revised North American Free Trade Agreement through Congress may hinge on a little-noticed provision governing intellectual property protections for new medicines, the New York Times writes. Congressional Democrats have seized on measures in the United States-Mexico-Canada Agreement that establishes protections for drug makers, saying they are a boon to the pharmaceutical industry and could undermine efforts to make American health care more affordable.

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Opinion: Name the much-criticized federal program that has saved the U.S. $2.3 trillion. Hint: it starts with Affordable

Fri, 03/22/2019 - 01:45

Even before the Affordable Care Act became law, about 90 percent of the conversation and criticism of it was about coverage. Little has been said about its ability to control costs.

March 23, the ninth anniversary of the ACA’s passage, presents a good opportunity to examine its legacy on cost control — a legacy that deserves to be in the foreground, not relegated to the background behind the exchanges, Medicaid expansion, and work requirements.

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Opinion: Canada’s legalization of marijuana offers a blueprint for the U.S.

Fri, 03/22/2019 - 01:40

When Canada legalized cannabis last fall, the country began blazing a trail that the U.S. should one day follow. There’s much to emulate about the Canadian government’s approach to legalization, and a few things to avoid, but having marijuana legalized on such a large scale so close to home will no doubt have a profound effect on America’s future treatment of the issue.

Medical or recreational marijuana is now legal in 33 U.S. states, even though its possession or use is illegal under federal law. It’s an untenable situation that individuals engaging in an activity that’s now legal in 60 percent of the country are violating federal law. This is problematic for marijuana users, as well as for the cannabis industry. And even though a market is taking shape to support the use of both medical and recreational marijuana, it’s proving to be a stilted effort at best.

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STAT Plus: Sage’s CEO reflects on progress treating postpartum depression and what Biogen’s big Alzheimer’s failure means

Fri, 03/22/2019 - 01:35

Postpartum depression is the most common complication of childbirth. Yet it’s a condition that often goes untreated because mothers fear being stigmatized if they report symptoms.

On Tuesday the Food and Drug Administration approved brexanolone, the first drug specifically targeted to treat postpartum depression. To be marketed as Zulresso, it’s the first drug developed by and approved from Sage Therapeutics of  Cambridge, Mass. Jeff Jonas, Sage’s CEO, recently chatted with STAT about the drug, its price, and how it’s administered. He also shared some thoughts on Biogen and the failure of its biggest hope for an Alzheimer’s drug.

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Digital health just had a record year. But is a day of reckoning ahead?

Fri, 03/22/2019 - 01:30

On paper, they are health care’s most promising upstarts — companies using data and software to detect the onset of debilitating diseases, deliver medical advice and treatments online, and monitor patients’ steps, sleep, weight, blood sugar, and heart function.

In 2018, digital health firms had a record year, raking in $8.1 billion from investors buying into the industry’s efforts to re-engineer the delivery of medical services, according to the venture capital firm Rock Health. That’s a 42 percent increase over the prior year.

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Alzheimer’s and amyloid: ‘It’s time to do something else’

Thu, 03/21/2019 - 14:46

If there is anything more certain than the failure of experimental Alzheimer’s drugs — nearly 300, at last count — it is the immediate reaction of many diehard supporters of the amyloid hypothesis: They insist that idea, which served as the basis for most of those compounds, is still sound.

Roche pulls the plug on its anti-amyloid antibody crenezumab in January, after it has no chance of showing any benefit? Not enough to kill the amyloid hypothesis. Merck bails on verubecstat, which shut down production of toxic amyloid, in 2017? Still not enough. Eli Lilly announces in 2016 that its anti-amyloid solanezumab failed to show benefit in people with mild Alzheimer’s? Nope, not dead yet.

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Listen: Another big Alzheimer’s failure, postpartum progress, and Long Island shores

Thu, 03/21/2019 - 14:28

Should Alzheimer’s researchers just give up on amyloid plaques? What will a new drug mean for moms with postpartum depression? And which coastal region of Long Island is superior?

We discuss all that and more on the latest episode of “The Readout LOUD,” STAT’s biotech podcast. With Damian Garde on vacation, our STAT colleague Matthew Herper joins us as a special guest co-host. First up, STAT senior science writer Sharon Begley helps us break down the very big and very disappointing news about the failure of Biogen’s closely watched experimental Alzheimer’s treatment, known as aducanumab. Next, Sage Therapeutics CEO Jeff Jonas calls in to talk about his company’s approval this week for a new drug for postpartum depression. Finally, Jeff sticks around for a special lightning round in which we make him weigh in on Theranos villain Elizabeth Holmes and the New England Patriots, among other topics.

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Will Trump’s new free speech order affect research funding?

Thu, 03/21/2019 - 13:06

WASHINGTON — The Trump administration on Thursday announced a plan to force universities that violate free-speech principles to forfeit billions of dollars in biomedical research and other scientific grants.

It is unclear, however, whether any universities might actually be impacted — and whether the requirements, unveiled in an executive order, represent a massive disruption for the country’s research infrastructure or a political statement that will leave scientific work untouched.

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STAT Plus: After the blowup of the biggest hope for Alzheimer’s, what’s next in the pipeline?

Thu, 03/21/2019 - 12:55

The experimental drug known as aducanumab has long been seen as the next big hope on the horizon for Alzheimer’s patients — but that hope came crashing down on Thursday, when developer Biogen announced that it was halting two late-stage studies of the treatment after an interim analysis showed it was unlikely to work.

Other companies, though, are moving forward with experimental drugs of their own. Some target those familiar amyloid plaques and tau tangles, others look to inflammation and synapse regeneration, and still another mines young blood in search of therapeutic effect.

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House Democrats request Purdue opioid documents, focusing on the role of the Sacklers

Thu, 03/21/2019 - 12:13

The House Oversight Committee is asking Purdue Pharma for documents that could shine a light on the billionaire family that owns the company and its alleged role in the opioid crisis.

In a letter to Purdue CEO Craig Landau, Democratic Reps. Elijah Cummings of Maryland, the committee’s chairman, and Mark DeSaulnier of California asked for a list of Sacklers who had served on the board of Purdue or worked as company officers. The lawmakers are also seeking documents prepared for the Sackler family about the company’s marketing strategies for its medications and communications between company employees and family members.

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A monkey born from frozen testicular tissue offers fertility hope to pediatric cancer survivors

Thu, 03/21/2019 - 11:00

Cancer treatments like chemotherapy can wipe out sperm production, so men who want to one day have children sometimes freeze some before they undergo treatment.

Boys who haven’t gone through puberty don’t have that option. An estimated 30 percent of childhood cancer survivors will be infertile.

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STAT Plus: Alzheimer’s drug failure leaves Biogen in a precarious place

Thu, 03/21/2019 - 10:10

Where does Biogen (BIIB) go from here?

The announcement from the Cambridge, Mass.-based biotech company that it is stopping two clinical trials of its Alzheimer’s drug aducanumab is certainly bad for patients, their families, and for anyone worried about developing this terrible, brain-destroying disease. It’s frustrating for researchers who believed medicines like aducanumab had some hope of slowing an affliction that has stymied all attempts at treating it for a decade and a half.

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STAT Plus: FDA panel chair and consumer advocate petition FDA to halt opioid approvals

Thu, 03/21/2019 - 10:00

Arguing that the Food and Drug Administration is “culpable” in creating the opioid crisis, a consumer advocacy group and a leading academic — who also chairs an FDA advisory panel — are calling for the agency to impose a moratorium on approving any new or reformulated opioids.

In a Citizen’s Petition filed with the FDA, Public Citizen and Dr. Raeford Brown, a professor of anesthesiology and pediatrics at the University of Kentucky, maintained the agency has displayed “dangerously deficient oversight” and that none of more than two dozen opioids approved between 2009 and 2015 provided benefits that outweighed the risks. Two drugs — Opana ER and Dsuvia — were singled out as examples.

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STAT Plus: CRISPR is ascending again, after scientists find ‘elegant’ fix for cancer worry

Thu, 03/21/2019 - 08:00

If the genome-editing system CRISPR-Cas9 is biology’s precise, disciplined, Swiss army knife, its march toward the clinic is more like the roller coaster from hell. One moment it’s riding high with the promise of curing devastating genetic diseases, then its prospects plummet after the discovery of previously unsuspected risks, and the next moment it turns out those risks are either overblown or avoidable. Buy another ticket and get back on board.

On Thursday, scientists led by one of the world’s foremost gene therapy experts reported a way around one of the more worrisome obstacles: that CRISPR’d cells might be prone to becoming cancerous, as two 2018 studies suggested.

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STAT Plus: Pharmalittle: Biogen and Eisai halt Alzheimer’s drug trials; FDA allows sale of some blood pressure drugs in shortage

Thu, 03/21/2019 - 05:54

Good morning. Elizabeth Cooney here, tag-teaming with Ed Silverman on a busy day. Let’s get right to the news.

Biogen (BIIB) and its Japanese pharma partner Eisai said Thursday that they were halting two Phase 3 clinical trials of aducanumab, a drug that was designed to slow the worsening of Alzheimer’s by targeting brain-destroying protein fragments known as beta-amyloid, STAT reports. An independent interim analysis concluded that aducanumab was unlikely to benefit Alzheimer’s patients compared to placebo when the trials completed, Biogen and Eisai said.

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Biogen halts studies of closely watched Alzheimer’s drug, a blow to hopes for new treatment

Thu, 03/21/2019 - 04:36

Alzheimer’s disease has beaten back another effort to tame it.

Biogen and its Japanese pharma partner Eisai said Thursday that they were halting two Phase 3 clinical trials of aducanumab, a drug that was designed to slow the worsening of Alzheimer’s by targeting brain-destroying protein fragments known as beta-amyloid.

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