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Wednesday, June 12, 2019

FDA Grants Priority Review To Roche Rituximab In Ped Blood Vessel Disorders

PEPRS STUDY IS FIRST GLOBAL TRIAL OF RITUXAN IN PEDIATRIC PATIENTS WITH GPA OR MPA

* RITUXAN IN COMBINATION WITH GLUCOCORTICOIDS IS ONLY FDA-APPROVED THERAPY FOR ADULTS WITH THESE TWO RARE FORMS OF VASCULITIS
* IF APPROVED, THIS WOULD BE FIRST PEDIATRIC INDICATION FOR RITUXAN

Novartis Cosentyx meets primary, secondary endpoints in psoriatic arthritis

Novartis announced that its Cosentyx (secukinumab) has achieved its primary and key secondary endpoint in the Maximise study of psoriatic arthritis (PsA).
Cosentyx is claimed to be the first and only fully-human biologic, which directly restricts interleukin-17A (IL-17A), a cornerstone cytokine engaged in the inflammation and development of PsA, psoriasis (PsO), and ankylosing spondylitis (AS).
According to the company, the ongoing 52-week phase IIIb trial met both its primary and key secondary endpoint with 63.1% of Cosentyx 300mg and 66.3% of Cosentyx 150mg patients achieving ASAS20 at week 12, respectively.
PsA, which is a complex disease with multiple manifestations driving patient symptoms, is estimated to affect up to 50 million people across the world.
Maximise is a double-blind, randomized and placebo-controlled phase IIIb study to assess the efficacy and safety of an immunosuppressant in the management of axial manifestations of PsA.
The company recruited 498 patients with PsA, linician-diagnosed axial involvements, spinal pain rated as >40/100 on a visual analog scale (VAS) and BASDAI >4 despite trial of at least two non-steroid anti-inflammatory drugs in the study.
Patients have been treated with subcutaneous Cosentyx 300mg or 150mg given weekly for four weeks and every four weeks thereafter.
The proportion of patients achieving an ASAS20 response with Cosentyx 300mg at week 12 was the primary endpoint of the study.

Dassault Systemes targets life sciences with $5.8 billion Medidata deal

France’s Dassault Systemes moved to build up its life sciences presence with a $5.8 billion cash deal to buy Medidata Solutions, a U.S. firm focused on clinical trials.
Dassault Systemes has been doing deals to diversify its technology and software businesses further and its agreed acquisition of Medidata, its largest, follows its purchases of companies including Trace Software and Argosim.
Medidata has a market capitalization of around $5.9 billion, Refinitiv Eikon data shows, while Dassault has a stock market value of around 36 billion euros ($41 billion).
Although the $92.25 per share offered marked a slight discount to Medidata’s closing price of $94.75 on June 11, analysts said that it was at a premium of 6.6% to Medidata’s 50-day average price of $86.50 over the last 50 days.
Medidata’s shares had also risen 5.5% to around $100 in after-hours trading on Tuesday, on growing speculation of a takeover by Dassault Systemes.

The French company added the Medidata takeover, which it said has a $5.8 billion enterprise value, would strengthen its position in life sciences and boost earnings from 2020 onwards.
“Multidiscipline scientific innovation and industrial performance call for a platform approach connecting the dots between people, ideas and data,” said Bernard Charlès, Vice Chairman and CEO of Dassault Systèmes.
Deloitte this year forecast strong growth in the life sciences industry, saying it would benefit from a general rise in spending on healthcare, which in turn would necessitate more spending on technology. (bit.ly/2evoaRZ)
France’s Dassault family has stakes in both Dassault Systèmes and the aerospace-focused Dassault Aviation company, but the two are separate entities.
Dassault Systeme’s finance director, Pascal Daloz, said the French company had also signed a debt financing deal worth around 4 billion euros to fund its purchase of Medidata.

Invest Securities said the size of the deal had taken some investors by surprise, but Roche Brune Asset Management fund manager Gregoire Laverne said it was seen as a positive step.
“Dassault Systemes nevertheless has a big enough balance sheet to able to finance part of the acquisition,” said Laverne, whose firms owns Dassault shares.
Medidata had 2018 revenue of $636 million, and Dassault Systemes expects to close the deal in the fourth quarter.

Nuvectra files U.S. application for expanded label

Nuvectra (NASDAQ:NVTR) has submitted an application to the FDA seeking a full-body MR-conditional approval for its Algovita SCS system. It hopes to gain the regulatory nod by year-end.
Shares are up 7% after hours.

CymaBay +4.8% as Raymond James fades 45% sell-off

Raymond James has upgraded CymaBay Therapeutics (NASDAQ:CBAY) to Strong Buy after today’s harsh market reaction to experimental data released this morning.
The stock is up 4.8% after hours.
Shares closed the day down 45.5% after disappointing data from an experimental therapy for NASH, a fatty liver disease.
That reaction was “overblown,” Raymond James’ Steven Seedhouse says, noting that the drug wasn’t factored into his models, and that he expected the stock to recover when the market considers the probability that other aggregate improvements “could translate into fibrosis/ballooning/inflammation benefit, irrespective of the lack of liver fat signal.”

Tuesday, June 11, 2019

Resetting Circadian Rhythm

Very brief exposure to light flashes while sleeping can help reset the body’s circadian clock and may prove to be an effective strategy for managing phase shift sleeping disorders.
Light flashes at levels of just 50 lux for 10 μsec every 15 sec induced phase shifts reaching 90% of maximum, reported Jamie Zeitzer, PhD, of Stanford University in California, from a study of 56 healthy young men and women.
The effect was not increased when the flash duration was lengthened to as much as 10 sec, Zeitzer said at SLEEP 2019, the annual joint meeting of the American Academy of Sleep Medicine (AASM) and the Sleep Research Society (SRS).
Previously, Zeitzer’s lab had found similar results with flashing light therapy, with a greater magnitude of effect than with continuous light. The current study was aimed at determining how low the flash brightness and duration could go while maintaining the effect.
During the first 14 days of two 16-day parallel studies, participants were asked to maintain a regular sleep/wake cycle — confirmed through actigraphy and sleep logs — to establish circadian phase stabilization.
Then, for the last 2 days, participants slept in specialized time-isolation labs, and circadian pacemaker phase was determined via salivary melatonin onset.
Light exposure occurred the first night in the sleep lab. Participants were forced awake 2 hours after their pre-established regular bedtime and exposed to 1 hour of flashes, delivered at 15-sec intervals.
Flashes of only 8 lux were enough to induce half the maximum phase shift, Zeitzer reported. For context, bright sunlight is about 100,000 lux; outdoor light dips to about 10 lux at twilight. Elevators are typically illuminated at roughly 100 lux.
In an interview with MedPage Today, Zeitzer said the flash light technique has the potential to be an effective therapeutic strategy for any sleep problems related to disruptions in circadian rhythm.
Common phase shift disorders include delayed sleep phase syndrome, characterized by the inability to get to sleep until very late at night; and advanced sleep phase syndrome, characterized by going to sleep very early in the evening and waking earlier than desired.
Current therapeutic strategies for these and other sleep phase disorders are often not terribly effective, Zeitzer said, because they rely on changing patient behavior.
“Anytime you require people to change behaviors there are going to be issues with compliance,” he said. “If we can deliver therapy during sleep, you take behavior out of the equation.”
Zeitzer and colleagues recently completed a preliminary study of the light flash stimulus in teenagers.
He explained that since teens have a biological drive to go to bed later, even a slight phase shift may have a big impact.
The teens in the study received the light flash stimulus nightly, two hours before they were scheduled to wake up. The goal of the stimulus was to reset to teens’ body clocks so that they would naturally feel sleepy about an hour earlier than normal.
“You can get bigger phase shifts, but we didn’t think it was realistic to think that a teen who normally goes to bed at 1 [a.m.] would go to bed at 10:30 [p.m.],” he said.
Funding for this research was provided by the Department of Defense.
Zeitzer reported no relevant relationships with industry related to this study.

AMA Votes Against Neutrality on Medicare for All

Some fear opposition to single-payer could leave association out of healthcare reform talks

The American Medical Association (AMA) House of Delegates on Tuesday reiterated its longstanding opposition to single-payer healthcare systems, including “Medicare for All,” despite warnings that the AMA risks being left out of crucial healthcare reform discussions.
On Tuesday, delegates voted down a proposal to shift the AMA’s official stance on single-payer insurance to neutrality.
“We proposed this amendment because we are concerned about the AMA’s ability to be invited to all healthcare reform conversations,” Daniel Pfeifle, of Sioux Falls, South Dakota, said on behalf of the Medical Student Section. “As long as we maintain our blanket opposition, our AMA cannot ensure we’re part of every conversation.”
“The way humans make decisions is highly influenced by how the options are presented to us,” said Abby Solom of Plymouth, Minnesota, speaking for that state’s delegation. “If we frame the discussion about healthcare delivery options firmly anchored to a position of opposition to one of those options, there is no way we can consider all of the options fairly. It’s disingenuous to believe otherwise. … We should support the medical students’ amendment and study how to best provide healthcare for the people of this country based on AMA principles and without pre-defined conclusions.”
Opponents of the proposal disagreed with the idea that the AMA would be left out of the discussion. “This is our American Medical Association; we’re comfortable that what’s best for patients is also best for the physicians who take care of those patients,” said former AMA president Daniel Johnson, MD. “The question we have to ask is, ‘What is best for [the] patients?'”
Johnson noted that the AMA will still continue to have a seat at the table “because we are the American Medical Association … We’re not conceding anything when we say that we want to continue to be opposed to the solution of single-payer.”
“I think we ought to put a stake in the heart of single-payer,” said former AMA president Donald Palmisano, MD. “We’ve done it before — we ought to do it again.”
The discussion came in regard to a report on the issue of covering the uninsured from the AMA’s Council on Medical Service (CMS), which recommended that the association support efforts included to improve the Affordable Care Act (ACA) and also continue its opposition to single-payer healthcare reform. “The council underscores that the AMA will continue to thoughtfully engage in discussions of health reform proposals, which will vary greatly in their structure and scope,” the report said. “Opposing single-payer proposals does not preclude that engagement, nor mean that the AMA will not evaluate health reform proposals that are introduced. Ultimately, our AMA, guided by policy, will continue forward in its efforts to advocate for coverage of the uninsured.”
In response, the Medical Student Section offered a proposal recommending that the AMA “revise existing policy to remove opposition to single-payer systems while preserving support for pluralism, freedom of choice, freedom of practice, and universal access for patients.”
“We need to get involved at the start — we can’t just be at the final table,” said Joy Lee, a medical student from Washington, D.C., who was speaking for herself. “When we have categorical opposition in our policy we can’t be there from the very beginning. … We are not asking for AMA to support single payer; what we are asking for is for the AMA to be involved in every proposal that comes out so we can shape final policy.”
But before that proposal could be voted on, Jeff White, MD, of Shreveport, Louisiana, who was speaking for himself, offered an opposing amendment, which said the AMA should “recognize that adoption of a single-payor [sic] system, while perhaps providing universal access for patients, is inconsistent with true pluralism, freedom of choice, and freedom of practice.” That amendment was voted down 122-430. The delegates then narrowly voted down the original amendment from the medical students by a vote of 254-292.
Medicare for All was constantly in the air during the first few days of the House of Delegates meeting. On Saturday, Medicare for All advocates — including physicians —rallied outside the meeting hotel and also disrupted the meeting proceedings going on inside, staging a “die-in” on the meeting room floor and unfurling a Medicare for All banner.
On Sunday, outgoing AMA president Barbara McAneny, MD, appeared at a reference committee meeting to discuss the CMS report. “The AMA proposal for reform supports health system reform alternatives that ensure pluralism, freedom of choice, freedom of practice, and universal access for patients,” she said. “While the ACA has made significant progress, more needs to be done in covering the remaining uninsured … The [report] recommendations support individually owned health insurance with tax credits inversely related to income … [It] has potential to cover millions more Americans.”
McAneny reminded the audience that under a previous Medicare reimbursement formula known as the “sustainable growth rate,” doctors would be left each year “wondering if we receive the threatened 20% cuts. Why would we want to expand that to all of healthcare?” she added. “While some may be disappointed that the council did not recommend removing the AMA’s opposition to single-payer proposals, be assured the AMA will be at the table when health reform proposals are introduced and debated.”
On Monday, Seema Verma, administrator of the Centers for Medicare & Medicaid Services, told the AMA delegates that “the impact of Medicare for All on physicians would be particularly detrimental. Now, I know that our system isn’t perfect, but it does afford you some ability to choose which payers you want to do business with, and what payment terms you’re willing to accept. Medicare for All would take away that choice.”
In other news from Tuesday’s meeting session, the delegates elected Lisa Egbert, MD, an ob/gyn from Dayton, Ohio, as the association’s next vice speaker. The person elected to that role usually goes on to become speaker of the House of Delegates and then the organization’s president-elect.