Wednesday, January 16, 2019
Collegium Pharmaceutical price target lowered to $33 from $35 at Needham
Needham analyst Serge Belanger lowered his price target on Collegium Pharmaceutical to $33 after the company’s recent FY19 outlook for Xtampza and Nucynta revenues of $100M and $205M at the midpoint – below the Street consensus of $115M and $219M. The analyst notes that while the guidance led to a 20% decline in the the company’s share value, it served as a “needed expectation reset with realistic and potentially beatable 2019 targets.” Belanger also keeps his Buy rating on Collegium Pharmaceutical, stating that his next focus is on “the near-term growth inflection of Xtampza weekly Rxs” and als
https://thefly.com/landingPageNews.php?id=2849629
Abbott to Acquire Cephea Valve Technologies
Abbott has exercised its option to purchase Cephea Valve Technologies, a privately held medical device company developing a less-invasive heart valve replacement technology for people with mitral valve disease. Financial terms were not disclosed. Abbott provided capital and secured an option to purchase Cephea in 2015. Mitral valve disease is the most common heart valve problem.
https://thefly.com/landingPageNews.php?id=2849637
Aeterna Zentaris receives EMA marketing clearance for macimorelin
https://thefly.com/landingPageNews.php?id=2849657
Tuesday, January 15, 2019
Creating clinical-grade bone
A team of scientists from the New York Stem Cell Foundation (NYSCF) Research Institute reported Friday in Stem Cell Research and Therapy that they have made valuable progress toward creating clinical-grade cells for treatment of bone disease and injury. In their study, the team identified two types of growth media that could support effective expansion of mesenchymal progenitor (MP) cells from stem cells in a clinically compatible, Good Manufacturing Practice (GMP) setting. GMP guidelines require that cells to be used as therapies are created without the use of animal-derived substances.
“NYSCF is committed to bringing effective cellular therapies to patients in need,” says NYSCF CEO Susan L. Solomon. “To establish these therapies, it is essential to produce high-quality cells that meet safety requirements for clinical use, which is a step that this research is helping us achieve.”
MP cells are important because they resemble mesenchymal stem cells (MSCs). MSCs can go on to form a variety of cell types, including bone cells, cartilage cells, muscle cells, and fat cells, and can modulate the behavior of many other types of cell types in the body. They are a frequent target for cell therapies in which healthy cells are introduced into the body to treat diseases or reconstruct tissues and organs. However, MSCs are often scarce and do not expand well enough to provide the amount of cells needed for an effective therapy. MP cells, on the other hand, can be produced in large numbers for each patient when generated from induced pluripotent stem cells (iPSCs), and therefore hold extraordinary promise for the treatment of blood, heart, and immune diseases as well as repair of damaged bone and cartilage.
“MP cells have been derived from iPSCs before, but never in a growth medium that does not contain animal-derived compounds,” says NYSCF — Ralph Lauren Senior Investigator Giuseppe Maria de Peppo, PhD, who led the study. “We are glad to see that MP cells grown in GMP-compliant media showed the same biological and functional properties as those grown in research-grade media that contains animal products. The results will help us plan for movement of these cells out of the lab and into the clinic.”
To test his question, the researchers compared MP cells grown in a medium supplemented with fetal bovine serum, a product derived from cows, to MP cells grown in two different media without animal products (referred to as “xeno-free”) — one supplemented with human platelet lysates and one commercial high-performance GMP medium (AllegroTM Unison Medium). The team found that while MP cells grown in the xeno-free and GMP media showed slightly different cell morphology, expansion potential, gene expression, and cytokine profile than those grown in the medium containing fetal bovine serum, the cells were healthy and functional in these new conditions. Collectively, the results show promise for the eventual application of MP cells in cellular therapies.
Story Source:
Materials provided by New York Stem Cell Foundation. Note: Content may be edited for style and length.
Journal Reference:
- Madison McGrath, Edmund Tam, Martina Sladkova, Athbah AlManaie, Matthew Zimmer, Giuseppe Maria de Peppo. GMP-compatible and xeno-free cultivation of mesenchymal progenitors derived from human-induced pluripotent stem cells. Stem Cell Research & Therapy, 2019; 10 (1) DOI: 10.1186/s13287-018-1119-3
Novel approach to suppressing therapy-induced tumor growth and recurrence
Following up on a groundbreaking 2018 study in which BIDMC’s Dipak Panigrahy, MD, demonstrated that dead and dying cancer cells killed by conventional cancer treatments paradoxically trigger inflammation that promotes tumor growth and metastasis, a new study led by Allison Gartung, PhD, describes a novel approach to suppressing chemotherapy-induced tumor growth in an ovarian cancer model. Gartung and colleagues’ findings were published in published in January in Proceedings of the National Academy of Science (PNAS).
Working in a mouse model of the disease, the team confirmed that chemotherapy-killed ovarian cancer cells induce surrounding immune cells called macrophages to release a surge of chemicals. Together, these chemicals, known as cytokines and lipid mediators, create an environment conducive to tumor growth and survival.
“Conventional cancer therapy is a double-edged sword — the very treatment meant to control cancer is also helping it to survive and grow,” said Gartung, a postdoctoral fellow in BIDMC’s Department of Pathology. “To prevent tumor recurrence after therapy, it is critical to neutralize the inherent tumor-promoting activity of therapy-generated debris.”
Next, the team showed that a newly synthesized anti-inflammatory drug called PTUPB — specifically designed to target the chemical pathways that lead to cytokines and lipid mediators — blocks the debris-stimulated surge of tumor-promoting chemicals by macrophages. In addition, the scientists found that PTUPB prolonged survival in mice bearing ovarian tumors and suppressed debris-stimulated tumor growth.
“The role of these chemotherapy-induced cytokines and lipids is underappreciated and poorly characterized, and ovarian cancer patients may benefit from suppressing their release,” said Panigrahy, Assistant Professor of Pathology and a Scientist at the Cancer Center at BIDMC. “Further research is needed but, our results indicate that PTUPB may complement conventional cancer therapies by acting as a ‘surge protector’ against cell debris-stimulated tumor growth.”
Story Source:
Materials provided by Beth Israel Deaconess Medical Center. Note: Content may be edited for style and length.
Journal Reference:
- Allison Gartung, Jun Yang, Vikas P. Sukhatme, Diane R. Bielenberg, Djanira Fernandes, Jaimie Chang, Birgitta A. Schmidt, Sung Hee Hwang, David Zurakowski, Sui Huang, Mark W. Kieran, Bruce D. Hammock, Dipak Panigrahy. Suppression of chemotherapy-induced cytokine/lipid mediator surge and ovarian cancer by a dual COX-2/sEH inhibitor. Proceedings of the National Academy of Sciences, 2019; 201803999 DOI: 10.1073/pnas.1803999116
Supreme Court justices lean toward hospitals in Medicare DSH case
Two U.S. Supreme Court justices on Tuesday pushed back on the federal government’s sweeping Medicare payment change cutting billions of dollars from hospitals, saying the procedure for the formula change didn’t reflect the magnitude of the policy’s impact.
In oral arguments before eight of the justices, Sonia Sotomayor and Neal Gorsuch both focused on how hospitals would be hit by the CMS’ alterations to its Medicare disproportionate share hospital payment formula in 2014. The change was put into place without a public notice-and-comment period, which several hospitals claim violates federal law.
The case has far-reaching implications for Medicare, the financial foundation for the healthcare system and accountable for about $750 billion.
The CMS and Justice Department contended that the new payment calculation does not fall into the category of so-called “substantive legal standard” and therefore didn’t require a public comment period, including feedback from hospitals.
Sotomayor bluntly told Justice Department attorney Edwin Kneedler she had a problem with the government’s position that the payment change didn’t amount to substantive policy given that the entire hospital industry is affected.
“I have a problem with that,” she said of the government’s argument. “And I know you say that, but I don’t know how you take this outside of being a policy, meaning it’s applying to every single provider uniformly.”
She was also skeptical that hospitals seeking to dispute the payment change—which garners a savings for the government at a net loss for industry—would be able to get real recourse from the agency’s adjudication board. Although HHS said hospitals should go to the board to dispute the payment change, Sotomayor said the board isn’t likely to overrule the agency.
“And what would happen” at the agency’s adjudication board, she asked. “The board would look at it and say we’re not going to listen, even though we’re required to listen, to the agency’s position; we’re going to tell them they’re wrong?”
Under the change, HHS factors Medicare Advantage enrollees in with traditional Medicare (or Part A) enrollees when calculating a hospital’s DSH payment.
Gorsuch doubled down on Sotomayor’s line of questioning, as Kneedler argued that a hospital win in this case would broadly impair Medicare’s ability to administer the program by forcing it to go through additional procedural hurdles when it makes regulations.
“I don’t doubt it’s more convenient for the government to proceed through adjudication of an individual case and announce a new rule that applies to the whole of society without inviting comment and providing notice to everyone affected,” Gorsuch said. “I get that that’s easier and preferable, certainly more efficient.”
However, he said, the government should also consider the scale of the impact of its payment change.
“Couldn’t Congress make rationally an alternative decision that informal rulemaking, not even formal rulemaking, that’s gone by the boards, but just informal notice and comment to affected parties in something as significant as changing the formula for Medicare for all Medicare providers nationwide, that maybe they should have 60 days to at least throw in their comments,” Gorsuch said.
Both Sotomayor and Gorsuch appeared to support the reasoning of newest Supreme Court Justice Brett Kavanaugh in his decision in the case for the U.S. Court of Appeals for the District of Columbia Circuit.
Kavanaugh wrote in his 2017 decision that the HHS decision to include Medicare Advantage in its payment calculation gave the change enormous significance for the hospitals affected. On Tuesday, he recused himself from the Supreme Court arguments because of his prior involvement with the case.
Of all the justices on the bench, Justice Stephen Breyer pushed hardest for the government’s argument to prevent additional administrative hurdles.
“You may be happy with this case, but not in others when policies take 19 years to take effect,” Breyer said.
Justice Ruth Bader Ginsberg did not participate in arguments as she is recovering from a cancer operation, but she will participate in the decision after reviewing briefs and the oral argument transcript.
The conflict over the Medicare DSH formula has a 15-year history starting in 2003 when HHS proposed through rulemaking to leave the Medicare Advantage population out in its calculation. After a public comment period, the agency finalized the rule in 2004 but reversed itself from the proposal by including the Medicare Advantage enrollees after all.
The regulation was struck down in courts and in 2013 HHS issued a new rule for future years. This left the payments between 2004 and 2013 in question, and if the government loses it estimates it will be on the hook for $3 billion to $4 billion in DSH payments.
Social Support Called Key to Good Mental Health After Stroke
Two-thirds of stroke survivors who live at home have good mental health, and social support plays an important role, researchers say.
The new study included 300 stroke survivors, aged 50 and older, in Canada. Survivors living in long-term care facilities, who tend to have the most serious disabilities, were not included.
Stroke survivors were said to be in good mental health if they “were happy and/or satisfied with their life on an almost daily basis and … were free of suicidal thoughts, substance dependence, depression and anxiety disorder for the past year,” said study lead author Esme Fuller-Thomson. She’s director of the Institute for Life Course and Aging at the University of Toronto in Ontario, Canada.
Stroke survivors who had at least one confidant were four times more likely to achieve good mental health after stroke than those who were socially isolated, the investigators found.
According to study co-author Lisa Jensen, “This suggests targeted interventions for socially isolated and lonely patients may be particularly helpful in optimizing well-being after a stroke.” Jensen recently graduated with a master’s degree in social work.
On the flip side, stroke survivors with chronic and disabling pain had much lower odds of complete mental health, she added. And other research has suggested that post-stroke pain is often underdiagnosed and undertreated.
“These findings highlight the importance of health professionals vigilantly assessing and treating stroke survivors for chronic pain,” Jensen said in a university news release.
Another key finding: Patients with a history of abuse in childhood or lifelong mental illness were less likely to achieve good mental health after a stroke, Fuller-Thomson said.
“It appears that childhood adversities cast a very long shadow over many, many decades. In this sample of Canadians aged 50 and older, stroke survivors who had a history of childhood physical abuse, sexual abuse or chronic parental domestic violence were only half as likely to be in complete mental health in comparison to those without these childhood traumas,” Fuller-Thomson explained.
“We hope that these findings of incredible resiliency in stroke survivors are encouraging to stroke patients, their families and the health profession,” Fuller-Thomson said. “There is a light at the end of the tunnel.”
The study was published online Jan. 9 in the Journal of Aging and Health.
More information
The National Stroke Association has more on life after a stroke.
SOURCE: University of Toronto, news release, Jan. 9, 2019
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