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Thursday, January 31, 2019

Medical cannabis relieves symptoms in children with autism

In a new study of patients with autism who are 18 years old and under, researchers from Ben-Gurion University of the Negev (BGU) and Soroka University Medical Center report that cannabis as a treatment for autism spectrum disorders appears to be a well-tolerated, safe and effective option to relieve symptoms including seizures, tics, depression, restlessness, and rage attacks.
In the study published in Scientific Reports, “Overall, more than 80 percent of the parents reported significant or moderate improvement in their child,” according to Lihi Bar-Lev Schleider, of the BGU-Soroka Clinical Cannabis Research Institute.
Autistic Spectrum Disorder (ASD) is an extensive developmental disorder that is expressed in almost all dimensions of the child’s development. It is now common to refer to this disorder as a wide range of Pervasive Developmental Disorders (PDD) in which there are various manifestations and symptoms.
According to BGU’s Dr. Gal Meiri of the Negev Autism Center, “We analyzed the data prospectively collected as part of the program of 188 ASD patients treated with between 2015 and 2017. The treatment in majority of the patients was based on cannabis oil containing 30 percent cannabidiol oil (CBD) and 1.5 percent tetrahydrocannabinol (THC). Symptoms, patient global assessment and side effects at six months were primary outcomes of interest and were assessed by structured questionnaires.”
Overall, after six months of treatment, 30 percent of patients reported a significant improvement, 53.7 percent reported moderate improvement, and only 15 percent had slight or no change.
Quality of life, mood and ability to perform activities of daily living were assessed prior to treatment and at six months. Good quality of life was reported by 31.3 percent of patients prior to treatment initiation. At six months, good quality of life more than doubled to 66.8 percent. Positive mood was reported as 42 percent before treatment and 63.5 after six months.
The ability to dress and shower independently improved significantly from cannabis treatment. Only a quarter (26.4 percent) reported no difficulty prior to the treatment while 42.9 percent improved their ability to dress and shower independently at six months.
Cannabis oil medication also significantly improved sleep and concentration. Good sleep and concentration were reported by 3.3 percent and zero percent respectively at the outset vs. 24.7 percent and 14 percent during an active treatment.
“While this study suggest that cannabis treatment is safe and can improve ASD symptoms and improve ASD patients’ , we believe that -controlled trials are crucial for a better understanding of the cannabis effect on ASD ,” says Dr. Victor Novack, of the BGU-Soroka Clinical Cannabis Research Institute.
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More die after surgery than from HIV, TB, and malaria combined

Around the world 4.2 million people die every year within 30 days after surgery—with half of these deaths occurring in low- and middle-income countries (LMICs), a new study reveals.
There is also a significant unmet need for surgery in LMICs and researchers believe that if operations were provided for all patients who need them the number of global post-operative deaths would increase to 6.1 million.
Researchers at the University of Birmingham published their analysis on the numbers of people dying within 30 days of surgery in a research letter to The Lancet. They estimate that more people die each year within 30 days after surgery than from HIV, tuberculosis, and malaria combined (2.97 million).
The Lancet Commission on Global Surgery identified that 313 million surgical procedures are performed each year, but little is known about the quality of surgery globally, as robust postoperative death rates are available for only 29 countries.
Researchers at the University’s NIHR Global Health Research Unit on Global Surgery analysed available information to estimate how many people around the world die after operations—based on surgical volume, case-mix and post-operative death rates adjusted for country income.
Dr. Dmitri Nepogodiev, Research Fellow at the University of Birmingham, commented: “Surgery has been the ‘neglected stepchild’ of global health and has received a fraction of the investment put in to treating infectious diseases such as malaria.
“Although not all postoperative deaths are avoidable, many can be prevented by increasing investment in research, staff training, equipment, and better hospital facilities. To avoid millions more people dying after surgery, planned expansion of access to surgery must be complemented by investment in to improving the quality of surgery around the world.”
Professor Dion Morton, Barling Chair of Surgery at the University of Birmingham and Director of Clinical Research at the Royal College of Surgeons of England, commented: “Surgery saves lives and can transform patients’ quality of life, but this study shows that a large number of patients die in the immediate postoperative period. As efforts continue to increase access to surgery around the world, there is also an urgent need for research to improve the quality and safety of surgery.”
The researchers project that expanding surgical services to address unmet need would add another 1.9 million post-operative deaths in LMICs each year. Based on 4.2 million deaths, 7.7% of all deaths globally occur within 30 days of surgery. This figure is greater than that attributed to any other cause of  globally except ischaemic heart disease and stroke .
At present, around 4.8 billion people worldwide lack timely access to safe and affordable  and it is estimated that there is an annual unmet need for 143 million procedures in LMICs.
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United Therapeutics data in Orenitram study met primary endpoints

United Therapeutics announced that key data from the FREEDOM-EV study of Orenitram extended-release tablets were shared during an oral presentation at the Pulmonary Vascular Research Institute Annual World Congress on Pulmonary Vascular Disease in Barcelona, Spain. The presentation was given by R. James White, M.D., Ph.D., Professor of Medicine, Pharmacology & Physiology in the Division of Pulmonary & Critical Care Medicine at the University of Rochester Medical Center and steering committee member for the FREEDOM-EV study. The primary endpoint of this pivotal, double-blind, placebo-controlled, event-driven trial in patients with pulmonary arterial hypertension was met. Orenitram decreased the risk of adjudicated clinical worsening events by 26% compared to placebo. These results were largely driven by delay in disease progression; Orenitram decreased the risk of disease progression by 61% compared with placebo. Mortality was similar between Orenitram and placebo groups at the end of randomized treatment. However, in participants for which data are available, Orenitram was associated with a 37% decreased risk of mortality compared with placebo. United Therapeutics has submitted the FREEDOM-EV study results to the U.S. Food and Drug Administration in support of a potential label amendment for Orenitram and is evaluating whether the results could support marketing applications outside the United States.
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Nuvectra can weather management change, says Piper Jaffray

Piper Jaffray analyst Matt O’Brien kept his Overweight rating and $25 price target on Nuvectra after the company announced an immediate departure of its CEO earlier today. The analyst says the company has a “suitable replacement in Dr. Parks”, adding that while the abrupt resignation was surprising, he sees Nuvectra management as “capable of weathering the transition”.
https://thefly.com/landingPageNews.php?id=2857373
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Titan Pharmaceuticals reports ‘positive’ initial results of Probuphine relaunch

Titan Pharmaceuticals, Inc. provided an update on the U.S. commercial relaunch of Probuphine implant, its unique six-month treatment for Opioid Use Disorder. Titan has successfully completed the program’s planned transition from Braeburn Pharmaceuticals. Important commercialization accomplishments include the recruitment and onboarding of highly qualified commercial and medical affairs personnel for all targeted geographies; the engagement of a leading public relations agency for the re-branding of Probuphine; and the retention of a well-known government relations firm to plan and execute a new lobbying strategy for the product. Titan also reengaged with health care providers who had previously treated patients with Probuphine, providing retraining and medical liaison assistance where needed and creating an integrated sales strategy to support them and their office staff. These accomplishments and other activities have contributed to a double-digit increase in total product shipments in the period following Titan’s assumption of responsibility for Probuphine sales in mid-June 2018. Based on preliminary information, total shipments of Probuphine during the rest of the year increased sequentially by over 20%. Titan expects to provide more details in its fourth quarter and full-year 2018 financial results, which it expects to release in late March 2019.
https://thefly.com/landingPageNews.php?id=2857365
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Trump administration to eliminate safe harbors for drug rebates to PBMs

The Trump administration wants to eliminate safe harbor protections for drug rebates negotiated by pharmacy benefit managers and instead, offer those protections to discounts passed directly to consumers.
The long-awaited rule (PDF), released Thursday evening, was under review at the Office of Management and Budget dating back to the summer.
Department of Health and Human Services Secretary Alex Azar said in a statement that eliminating the safe harbors would increase transparency in the black box of the pharmacy supply chain.
“Every day, Americans—particularly our seniors—pay more than they need to for their prescription drugs because of a hidden system of kickbacks to middlemen,” Azar said. “President Trump is proposing to end this era of backdoor deals in the drug industry, bring real transparency to drug markets and deliver savings to patients directly when they walk into the pharmacy.”
PBMs have shouldered a significant amount of blame in the public discourse over rising drug prices. Azar has been both a critic and defender of PBMs and the rebate system they operate in, saying that pharmacy benefit managers will be key partners in reforming the drug supply chain, but also that they’re an impediment to change.
Drug rebates negotiated by PBMs are, at present, protected from Stark Law and anti-kickback statute challenges. HHS is calling instead to offer those protections for discounts that are passed on to patients, saying it could especially benefit Medicare Part D patients with high out-of-pocket costs.
PBMs take the savings from negotiated rebates and typically apply it broadly across premiums instead of directly passing each discount on to their members at the counter.
In a statement, the Pharmaceutical Care Management Association CEO JC Scott said that eliminating the safe harbor protections could lead to concerns about access to some drugs. Scott highlighted several studies that indicate PBMs are not to blame for rising drug costs.
“Any proposals to eliminate PBM-negotiated rebates must consider the impact it will have on Medicare beneficiaries’ access to affordable prescription drugs and costs to taxpayers,” Scott said.
In addition to allowing safe harbors for savings directly to consumers, HHS is proposing protections for fixed fee agreements between pharmaceutical companies and PBMs. In this protection, service fees drug companies pay to PBMs for services applicable only to the manufacturer—not a payer—would be covered if they meet certain criteria.
On a call with reporters, a senior official at HHS said that the goal of the rule is to “correct the perverse incentives” in the drug supply chain that can lead to exclusive formularies and higher costs for patients. The official said the rule may be “the single most significant reform ever implemented” in addressing the way drugs are priced and paid for.
“We know that the incentives in the current system lead to higher list prices,” the official said. “Everyone in the supply chain benefits—except for the patient—when list prices go up.”
A senior official at the HHS Office of Inspector General said on the call that while the rule mainly impacts PBM rebates paid to members of federal payers, but the rulemaking could have ripple effects in the commercial sector.
The OIG official said the agency is seeking feedback on the potential impacts of the change.
The HHS official said the agency is targeting Jan. 1, 2020 to end the existing safe harbors and to launch the new ones within 60 days of the rule’s finalization. That said, PBMs and drug companies can begin these negotiations “now,” the official said, to bring down prices.
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California sees 24% dive in new ObamaCare plan enrollments

  • New enrollments in California’s Affordable Care Act marketplace dropped 23.7% for 2019, down to 295,980 from 388,344 last year. Officials are pinning the blame on loss of the federal tax penalty for people without health insurance. The plunge came despite a statewide bus tour to promote getting coverage ahead of the Jan. 15 deadline for 2019 open enrollment in the state, one of about a dozen states to run its own exchange.
  • CMS Administrator Seema Verma, however, pushed back again the explanation given by the state-run exchange, known as Covered California. On Twitter, she noted the state’s $100 million advertising spend didn’t seem to help its numbers and pointed to slow enrollment in New Jersey, which has enacted its own mandate. “Mandates aren’t the answer, and advertising isn’t the answer,” she wrote. “Americans need more choices and more affordable healthcare options.”
  • Overall enrollment was on par with 2018, with 1.5 million plan selections, according to an early analysis released Wednesday. The steady enrollment was driven largely by renewals, which increased 7.5% year over year to 1,217,903 for 2019, officials said.

The decline in new sign-ups was worse than anticipated and greater than the average 15.8% drop in the 39 states served by the federal marketplace, Healthcare.gov. Covered California officials attributed the difference to steady declines in enrollment in those states over the past four years.
The number of new enrollees in the federal marketplace plunged 49% from 4 million in 2016 to 2.1 million in 2019, in part because of the Trump Administration’s decision to drastically scale back public awareness campaigns ahead of the open enrollment season.
In addition to the penalty’s impact, the analysis found fewer new enrollees who selected bronze plans, the lowest premium option in Covered California. The number of new bronze plans fell 30.5% from 143,000 to 100,000. Among unsubsidized enrollees, the drop was even steeper — down 38.1%.
Enrollment in populations where English is not the preferred spoken language also declined, particularly among Mandarin speakers (28%), Spanish speakers (29%) and Korean speakers (46%).
Other demographics did not seem to affect coverage.
“With the reduction being evenly spread across demographics, the primary driver of the loss of new enrollees appears to be removal of the individual mandate penalty,” Peter Lee, executive director of Covered California, said in a statement.
Lee added that the decline in new enrollments “affirms the leadership Gov. Gavin Newsom has taken to propose an individual mandate and enhanced subsidies aimed at making coverage more affordable for Californians.”
The results reflect several actions last year likely to undermine enrollment in the ACA exchanges. First and foremost was Congress’ elimination of the individual mandate penalty. The other is the administration’s promotion of short-term and association health plans.
Still, the ACA exchanges are showing signs of stabilizing this year, with more payers in the exchanges and light premium increases, according to an Urban Institute report funded by the Robert Wood Johnson Foundation. The smaller premium increases are likely due to payers scaling back after over-adjusting for uncertainty in the 2018 plan year, according to the report.
Meanwhile, insurers continue to look for ways to limit risk, such as HMOs and narrow provider networks, which limit patient choice but give payers more control of costs.
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CMS proposes more nontraditional benefits for Medicare Advantage plans

  • Medicare Advantage plans will be able to offer more nonmedical supplemental benefits to patients with chronic illness under guidance CMS released Wednesday. The MA and Medicare Part D advance notice (Part II) and draft letter also put forward proposals aimed at combating the nation’s opioid epidemic, such as encouraging cost-sharing reductions for patients with chronic pain or those receiving addiction treatment.
  • The proposed policies build on a rule in effect this month allowing MA plans to include benefits like transportation to medical appointments and home meal delivery. “We’ve really opened it up now as part of this proposal to any benefit that improves or maintains healthcare,” CMS Principal Deputy Administrator for Medicare Demetrios Kouzoukas told reporters.
  • The expected average change in revenue for 2020 MA plans as a result of the policy changes would be an increase of 1.59%, the agency said, down markedly from the 3.4% increase for 2019.
Medicare Advantage enrollment is a growth area for payers aimed at seniors who want more benefits beyond traditional Medicare. The number of seniors in an MA plan rose 8% from 2016 to 2017, according to the Medicare Payment Advisory Commission. CMS has previously said 270 plans were offering the new, more flexible benefits for 2019.
Additional benefit options will be good news for companies looking to capitalize on growing awareness of the effects socioeconomic factors have on health outcomes. Uber and Lyft both have dedicated healthcare platforms, for example.
Also on the tech front, Apple is reportedly in talks with multiple MA plans, looking for partnerships involving the Apple Watch, which can help wearers track their activity levels, flag changes in heart rate and detect major falls.
CMS has been active lately in its proposals for the MA program. Earlier this month, the agency announced two new voluntary payment models, including one expanding access to telehealth and providing mechanisms to reward beneficiaries for healthy behaviors.
Part I of the advance notice, released in late December, proposed a change to the methodology for calculating risk adjustment payments for MA plans to include more encounter data. Comments on both parts are due by March 1, and CMS expects to release the final rate announcement and call letter by April 1.
In the proposals released Wednesday, CMS also suggested changes to its Part C and D star ratings methodology, including removing three measures starting in 2022 for “low statistical reliability.” The measures are adult BMI assessment (Part C), appeals auto-forward (Part D) and appeal upheld (Part D).
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New VA rules reignite privatization debate

  • The Department of Veterans Affairs proposed new standards to make it easier for veterans to seek care outside the VA. The changes, due to take effect in June, include dropping the wait time requirement from 30 days to 20 days for primary and mental care and 28 days for specialties.
  • Changes also include shifting one requirement from driving distance (40 miles) to driving time (30 minutes). For specialty care, the VA is proposing a 60-minute average drive time standard.
  • The proposals come several years after the agency got a black eye in a scandal showing officials falsified data on patient wait times and amid fears the Trump administration wants to privatize the agency.

The measures are part of the agency’s implementation of last year’s MISSION Act, which critics say marked another step toward privatizing the VA. The right leaning Koch brothers helped fund these efforts, but most veterans’ groups oppose them. That’s in large part because, in many cases, VA care is exceptionally good — if exceptionally slow.
Veterans who rely most on VA care tend to be younger, poorer and live in rural areas, a 2016 RAND report found, while only 25% of veterans live within an hour of a VA medical facility.
Veterans’ groups held their fire for now while they study the new rules. Still, Rory Riley, a consultant for veterans organizations such as the National Organization of Veterans’ Advocates, called the new access standards a “step in the right direction.”
Changing the driving distance standard to drive time, for example, makes the standards better align with TRICARE. In all, Riley told Healthcare Dive, the VA proposed standards are similar to TRICARE’s existing standards for TRICARE Prime, which many veterans are already familiar with.
“TRICARE hasn’t been ‘privatized’ despite using very similar access standards and utilizing a mix of DoD and community providers. A good policy choice, as opposed to a political one, is integrating the best of both government and community care,” Riley said. “I’m the first one to criticize VA when I think they’ve done something that is misguided, but I actually think these standards are a good faith effort to implement the MISSION Act, which the VA is legally required to comply with.”
Other changes include the ability to access urgent care, as long as the provider is in the VA’s community care network — though they may be charged a copayment.
Leadership at the VA has been in turmoil in recent years, with the fired VA Secretary David Shulkin, warning in a New York Times op-ed days after his ousting that the private sector is “ill-prepared” to handle veterans, “particularly when it involves the mental health needs of people scarred by the horrors of war.”
Current VA Secretary Robert Wilkie tried to get an edge on critics who may lambast the access standards for enabling privatization.
“Although these new standards represent an important win for America’s Veterans, they will not be without controversy,” the secretary said. “Some will claim falsely and predictably that they represent a first step toward privatizing the department.”
He cited recent studies from Rand, Dartmouth and JAMA that show the VA is outperforming the private sector in quality and customer service.
A 2014 Congressional Budget Office report showed 70% of veterans enrolled in the VA’s system already receive most of their care in the private sector.
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Inspire Medical announces positive coverage policy by BCBSNC

Inspire Medical Systems announced that Blue Cross Blue Shield of North Carolina, or BCBSNC, has issued a positive coverage policy of Inspire therapy. This is the third coverage policy issued by a Blue Cross Blue Shield Association healthcare plan following BCBSA Evidence Street’s January 7 report, which stated that there is sufficient evidence to determine that Inspire therapy results in a meaningful improvement in net health outcomes for patients meeting specified criteria. BCBSNC, an independent licensee of BCBSA, is the state of North Carolina’s largest insurer and covers approximately 3.9M members.
https://thefly.com/landingPageNews.php?id=2857263
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Brookfield Business Partners to acquire Healthscope for approximately $4.1B

Brookfield Business Partners, together with institutional partners, is pleased to announce that it has reached an agreement to acquire up to 100% of Healthscope Limited for approximately $4.1B. Healthscope is the second largest private hospital operator in Australia and the largest pathology services provider in New Zealand. The transaction will be funded with up to $1B of equity, $1.4B of long-term financing and $1.7B from the sale and long-term leaseback of 22 wholly-owned freehold hospital properties. Brookfield Business Partners expects to fund approximately one third of the equity, with the balance being funded by institutional partners. Prior to or following closing, a portion of Brookfield Business Partners’ commitment may be syndicated to other institutional investors. Closing of the transaction remains subject to necessary shareholder and court approvals, as well as customary closing conditions including, among others, regulatory approvals. Closing is expected to occur in the second quarter of 2019.
https://thefly.com/landingPageNews.php?id=2857353
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Dynamic aspirin: Molecular vibrations drive electrons over large distances

Aspirin is not only an important drug but also an interesting physics model system in which molecular vibrations and electrons are coupled in a particular way. For the first time, x-ray experiments in the ultrashort time domain make electron motions visible in real time. They demonstrate that very small atomic displacements shift electrons over much larger distances within the aspirin molecules.
Aspirin pills consist of many small crystallites in which molecules of acetylsalicylic acid form a regular spatial arrangement. The molecules couple to each other via comparably weak interactions and generate electric fields which exert a force on the electrons of every molecule. Upon excitation of molecular vibrations, the distribution of electrons in space and, thus, the chemical properties should change. While this scenario has been a subject of theoretical work, there has been no experimental demonstration and understanding of the molecular dynamics so far.
Scientists of the Max Born Institute in Berlin, Germany, have now gained the first and direct insight in electrons motions during a coupled vibration of the aspirin molecules. In a recent issue of the journal Structural Dynamics [6,014503 (2019)], they report results of an x-ray experiment in the ultrashort time domain. An ultrashort optical pump pulse induces vibrations of the aspirin molecules with a vibrational period of approximately 1 picosecond (ps, a millionth of a millionth of a second). An ultrashort hard x-ray pulse, which is delayed relative to the pump pulse, is diffracted from the excited powder of crystallites to map the momentary spatial arrangement of electrons via an x-ray diffraction pattern.
The rotational motion of the methyl (CH3) group of an aspirin molecule arises upon vibrational excitation. In the animation, the atomic displacements are artificially enlarged to make them visible. The methyl rotation is connected with a spatial shift of electrons over the entire aspirin molecule (yellow clouds, so-called isosurface of constant electron density). The periodic electron motions occur in time with the vibrational motions of the atoms and the distances traveled by the electrons are typically 10000 times larger than the atom displacements in the methyl rotation. This behavior demonstrates the hybrid character of the methyl rotation which is comprised of both atomic and electron motions on totally different length scales. The hybrid character originates from the electric interaction between the aspirin molecules and the dynamic minimization of electrostatic energy in the crystallite.
These new results underline the central role of hybrid modes for the stabilization of the crystal structure, in agreement with theoretical calculations. In the case of aspirin, this property favors the so-called form 1 of the crystal structure compared to other molecular arrangements. The strong modulation of the electron distribution by vibrations is relevant for numerous crystal structures in which electric interactions prevail. Vibrational excitations of ferroelectric materials should allow for an ultrafast switching of the macroscopic electric polarization and, thus, lead to new electronic devices for extremely high frequencies.
Story Source:
Materials provided by Forschungsverbund Berlin. Note: Content may be edited for style and length.
Journal Reference:
  1. Christoph Hauf, Antonio-Andres Hernandez Salvador, Marcel Holtz, Michael Woerner, Thomas Elsaesser. Phonon driven charge dynamics in polycrystalline acetylsalicylic acid mapped by ultrafast x-ray diffraction. Structural Dynamics, 2019; 6 (1): 014503 DOI: 10.1063/1.5079229
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Incyte 1st Patient Treated in Phase 3 Graft-Versus-Host Disease Trial

Incyte Corporation(Nasdaq:INCY) announced that the first patient has been treated in GRAVITAS-309, a pivotal Phase 3 trial for the first-line treatment of patients with chronic graft-versus-host disease (GVHD). The trial will evaluate the efficacy and safety of itacitinib, Incyte’s novel and selective JAK1 inhibitor, in combination with corticosteroids compared to corticosteroids alone as a first-line treatment for moderate or severe chronic GVHD (see also Incyte Corporation).
“Given the severity of chronic GVHD, we are pleased to announce the initiation of treatment for the first patient in the GRAVITAS-309 trial, as it represents a critical next step in our comprehensive development program aiming to bring important treatment options to market that address the significant unmet needs of GVHD patients across the spectrum of the disease,” said Steven Stein, M.D., Chief Medical Officer, Incyte.
GVHD is a condition that can occur after an allogeneic stem cell transplant (the transfer of stem cells from a donor), where the donated cells initiate an immune response and attack the transplant recipients organs, leading to significant morbidity and mortality. There are two forms of GVHD, acute and chronic, which can affect multiple organ systems including the skin, gastrointestinal (digestive) tract and liver.
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Oxycodone Market Seen Up on Chronic Disease, Trauma Condition Growth

Expanding at a rather modest annual growth rate of 4.6 percent, the global market for oxycodone is projected to reach a revenue of US$ 4 Billion in 2028—showcasing an absolute dollar opportunity of US$ 181.3 Mn, through 2018-2019. Future Market Insights, in its recent analysis of the global oxycodone market, elaborates on the key market dynamics, opportunity assessment, and regional and competitive landscape analysis, for a period spanning 2018 to 2028.
With nearly 10-fold increase in the use of opioids since its inception, the oxycodone contributes to one of the largest revenue generator in the overall pharmaceutical landscape. Intensifying sales of oxycodone can be attributed to:
Increasing patent expirations for branded products and much lesser new product launches, translating into increased consumption of generics—that contribute to the maximum revenue of the global oxycodone market, thereby, fueling the net sales.
Growing number of cancer treatments, which in turn, increases the demand for supportive care medications for pain management. Increased prescriptions of oxycodone and Hydrocodone for treating cancer pain, will remain the largest contributor to the sales growth of the aforementioned medication.
“In terms of demand, high efficiency of synthetic and semi-synthetic opioids increase its use. In addition, Opioids prescription is highly regulated by a set of clinical practice guidelines, while ensuring safe access and proper dosage. Opioids are covered under such stringent regulations translates into increased consumption. Rising awareness about palliative care in terminal disease conditions combined with favorable reimbursement policies are some additional demand-side factors, augmenting the consumption of opioids”, projects a senior analyst at FMI
Elaborating further, the analyst explains that palliative care programs in US—which includes palliative care consultation teams and dedicated in-patient palliative care units—are delivered in accordance with the government and commercial reimbursement policies, further boosting the oxycodone market in the region. In addition to palliative programs, increased prescription in de-addiction programs, is well contributing to the demand of de-addiction opiates.
Innovative Drug Formulations Pushing Oxycodone Global Sales
In the in-depth analysis of the oxycodone market, FMI underlines the introduction of innovative opiate drugs, currently occupying a lion’s share. Innovations in formulations—not necessarily targeted at drug efficacy— is a critical supply-side driver in the global oxycodone market. Abuse-deterrent formulations in Oxycontin, by Purdue Pharma is one such example. Moreover, Purdue has been granted exclusive selling rights for Oxycontin till 2030, after it made formulations changes to the drug’s chemical structure, thereby marketing it as an ‘abuse-proof’, slow-releasing pill. In addition, FDA’s nod to new generation drugs, making them ‘less-addictive’, will gain prominence through 2028. Drug advancements in extended-release medications for pain control, would supplement to the sales of oxycodone, globally. This scenario is expected to create favorable adoption opportunities for long-standing oxycodone, notes FMI in its report titled “Oxycodone Market Global Industry Analysis 2013-2017 and Opportunity Assessment 2018-2028”.
Opportunity Analysis of Oxycodone Market Reveals Lucrative Growth Prospects
  • In terms of business expansion opportunities, strategic investments, licensing agreements, and acquisitions hold significant potential.
  • Apart from the above mentioned, investments in research and development activities would present potential growth opportunities for oxycodone manufacturers.
  • Increasing strategic collaborations between manufacturers and generic drugs distributors operating in the pain management business, will prove critical to forward expansion plans.
  • As demand for oxycodone remains uniform across patients of all age groups, opioids are expected to offer effective drug formulations and enhanced solubility of API, further prompting manufactures to capitalize on the emerging latent opportunity.
  • Rising prevalence of chronic diseases in humans and increasing demand for parenteral formulations around the world, particularly in North American countries, will supplement to the growth of oxycodone market in the region.
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Corcept sees Q4 revenue below consensus

On a preliminary basis, Corcept Therapeutics (NASDAQ:CORT) expects a 25% jump in Q4 revenue to $66.8M, below consensus of $70.4M.
2018 revenue will be up 58% to $251.2M, also shy of consensus of $254.8M.
2019 guidance: Revenue: $285M – 315M.
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New approach to peripheral nerve injury?

In animal models of a totally crushed peripheral nerve, the damaged axons are broken down, allowing healthy ones to regrow. But humans rarely suffer complete axonal damage. Instead, axons tend to be partially damaged, causing neuropathic pain — a difficult-to-treat, chronic pain associated with nerve trauma, chemotherapy and diabetes. A new study in Cell, led by Michael Costigan, PhD, at Boston Children’s Hospital, explore the role of immune cells in breaking down damaged nerves. The findings may change our understanding of neuropathic pain and how to treat it.
The study was published online on January 31.
Targeted destruction
Early in their work, Costigan’s collaborators in Seoul, South Korea, noticed that immune cells called natural killer (NK) cells would strip away the axons of neurons in a petri dish. NK cells are part of our body’s rapid, innate immune response to threats such as viruses and cancer.
The team then started growing sensory neurons in a petri dish. They noticed these dissociated neurons began expressing large amounts of RAE1, a protein that invites NK cells to attack. When these neurons were co-cultured with activated NK cells, the NK cells began breaking down the injured nerves.
“We found that the natural killer cells would eat away at the axons of the neurons, but wouldn’t destroy their cell bodies,” says Costigan, co-senior author on the Cell paper with Seog Bae Oh, PhD, of Seoul National University. “This which was exciting as it allowed for the possibility that new, healthy axons could grow from them.”
Watching immune cells and neurons interact in live mice
The team then looked to see whether these results held up in a living animal. They increased the function of NK cells in mice and then partially crushed their sciatic nerve, the main nerve that runs down the back of the leg. Then they waited and watched.
“It was as if the neurons knew what happened,” says Costigan. “They started to express the receptors that leave them susceptible to a natural killer cell attack. And the natural killer cells were responding, coming into the nerve and clearing those damaged axons.”
Within days after the nerve crush, tests indicated that the immune-stimulated mice had significantly reduced sensation in the affected paw. But once the damaged axons were cleared, healthy ones began to grow back in their place. At around two weeks after the crush, the mice’s paws regained sensation.
Other mice, whose NK function wasn’t enhanced, had a similar recovery timeline. But because their partially damaged axons hadn’t been cleared away as efficiently, tests continued to show high levels of touch-induced pain 30 days or more after the injury. This scenario is analogous to human neuropathic pain, in which damaged nerves that aren’t fully broken down may continue sending pain signals to the brain, causing chronic pain and hypersensitivity.
Looking to the future
Interfering with the immune system always carries risk, but the team’s work suggests that finding a way to modulate NK cell function could perhaps clear out damaged axons, allowing healthy axonal regrowth and potentially decreasing chronic neuropathic pain. Ultimately, understanding more about the role of NK cells in selective axonal degeneration will lead to a greater understanding of the mechanisms behind neuropathic pain. And with greater understanding, better treatments will follow.
Story Source:
Materials provided by Boston Children’s Hospital. Note: Content may be edited for style and length.
Journal Reference:
  1. Alexander J. Davies, Hyoung Woo Kim, Rafael Gonzalez-Cano, Sophie Ugolini, Michael Costigan, Seog Bae Oh. Natural Killer Cells Degenerate Intact Sensory Afferents following Nerve Injury. Cell, 2019 DOI: 10.1016/j.cell.2018.12.022
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Fasting ramps up human metabolism

A study by the G0 Cell Unit and Kyoto University researchers suggests that fasting, which puts the body in ‘starvation mode,’ leads to fuel substitution, antioxidation, increased mitochondrial activation and altered signal transduction.
Credit: OIST
Fasting may help people lose weight, but new research suggests going without food may also boost human metabolic activity, generate antioxidants, and help reverse some effects of aging. Scientists at the Okinawa Institute of Science and Technology Graduate University (OIST) and Kyoto University identified 30 previously-unreported substances whose quantity increases during fasting and indicate a variety of health benefits.
“We have been researching aging and metabolism for many years and decided to search for unknown health effects in human fasting,” said Dr. Takayuki Teruya, first author of the paper and a technician in the OIST G0 Cell Unit, led by Prof. Mitsuhiro Yanagida. “Contrary to the original expectation, it turned out that fasting induced metabolic activation rather actively.”
The study, published January 29, 2019 in Scientific Reports, presents an analysis of whole human blood, plasma, and red blood cells drawn from four fasting individuals. The researchers monitored changing levels of metabolites — substances formed during the chemical processes that grant organisms energy and allow them to grow. The results revealed 44 metabolites, including 30 that were previously unrecognized, that increased universally among subjects between 1.5- to 60-fold within just 58 hours of fasting.
In previous research, the G0 Cell Unit identified various metabolites whose quantities decline with age, including three known as leucine, isoleucine, and ophthalmic acid. In fasting individuals, these metabolites increase in level, suggesting a mechanism by which fasting could help increase longevity.
“These are very important metabolites for maintenance of muscle and antioxidant activity, respectively,” said Teruya. “This result suggests the possibility of a rejuvenating effect by fasting, which was not known until now.”
Metabolites Give Clues to Mechanism and Health Effects
The human body tends to utilize carbohydrates for quick energy — when they’re available. When starved of carbs, the body begins looting its alternate energy stores. The act of “energy substitution” leaves a trail of evidence, namely metabolites known as butyrates, carnitines, and branched-chain amino acids. These well-known markers of energy substitution have been shown to accumulate during fasting.
But fasting appears to elicit effects far beyond energy substitution. In their comprehensive analysis of human blood, the researchers noted both established fasting markers and many more. For example, they found a global increase in substances produced by the citric acid cycle, a process by which organisms release energy stored in the chemical bonds of carbohydrates, proteins and lipids. The marked increase suggests that, during fasting, the tiny powerhouses running every cell are thrown into overdrive.
Fasting also appeared to enhance the metabolism of purine and pyrimidine, chemical substances which play key roles in gene expression and protein synthesis. The finding suggests fasting may reprogram which proteins cells build at what time, thus altering their function. The change may promote homeostasis in cells, or serve to edit their gene expression in response to environmental influences.
When metabolized, purine and pyrimidine also boost the body’s production of antioxidants. Several antioxidants, such as ergothioneine and carnosine, were found to increase significantly over the 58-hour study period. Antioxidants serve to protect cells from free radicals produced during metabolism. Products of a metabolic pathway called the “pentose phosphate pathway” also stay the harmful effects of oxidation, and were similarly seen to increase during fasting, but only in plasma.
Newfound Health Benefits of Fasting?
The authors suggest that these antioxidative effects may stand as the body’s principal response to fasting, as starvation can foster a dangerously oxidative internal environment. Their exploratory study provides the first evidence of antioxidants as a fasting marker. In addition, the study introduces the novel notion that fasting might boost production of several age-related metabolites, abundant in young people, but depleted in old.
“Recent aging studies have shown that caloric restriction and fasting have a prolonging effect on lifespan in model animals…but the detailed mechanism has remained a mystery,” said Teruya. “It might be possible to verify the anti-aging effect from various viewpoints by developing exercise programs or drugs capable of causing the metabolic reaction similar to fasting.”
The findings expand on established ideas of what fasting could do for human health. The next step would be to replicate these results in a larger study, or investigate how the metabolic changes might be triggered by other means.
“People are interested in whether human beings can enjoy the effects of prevention of metabolic diseases and prolonging life span by fasting or caloric restriction, as with model animals,” said Teruya. “Understanding the metabolic changes caused by fasting is expected to give us wisdom for maintaining health.”
Story Source:
Materials provided by Okinawa Institute of Science and Technology (OIST) Graduate University. Note: Content may be edited for style and length.
Journal Reference:
  1. Takayuki Teruya, Romanas Chaleckis, Junko Takada, Mitsuhiro Yanagida, Hiroshi Kondoh. Diverse metabolic reactions activated during 58-hr fasting are revealed by non-targeted metabolomic analysis of human blood. Scientific Reports, 2019; 9 (1) DOI: 10.1038/s41598-018-36674-9
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Edwards Lifesciences sees Q1 adjusted EPS $1.15-$1.25, consensus $1.30

Sees Q1 revenue $950M-$1.01B, consensus $997.57M.
https://thefly.com/landingPageNews.php?id=2857251
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LHC Group, UNity Health announce joint venture in Arkansas

LHC Group and Unity Health announced finalization of an equity partnership agreement to purchase and share ownership of two home health providers in Arkansas: Unity Health – White County Medical Center Home Health in Searcy and Unity Health – Harris Medical Center Home Health in Newport. The agencies serve patients and families in their respective communities and the Northeast Arkansas region with in-home healthcare. With the closing of the joint venture agreement, LHC Group will oversee the day-to-day operations of both agencies which will continue service from their current locations under a new name: Unity Health HomeCare. LHC Group expects annualized revenue from this joint venture of approximately $4M and that it will not materially affect its 2019 diluted earnings per share.
https://thefly.com/landingPageNews.php?id=2857259
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Corcept Therapeutics reports Q4 revenue $66.8M, consensus $70.42M

https://thefly.com/landingPageNews.php?id=2857204
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Onconova to present at key opinion leaders meet

Onconova Therapeutics, Inc. (Nasdaq: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), today announced it will host a KOL breakfast for security analysts and institutional investors on Thursday, February 7, 2019, in New York City.
The event will include presentations by Lewis Silverman, MD, Associate Professor of Medicine and Director of the Translational Research Center for the Myelodysplastic Syndrome in the Division of Hematology/Oncology/Tisch Cancer Institute and Rajwanth Veluswamy, MD, MSCR, Assistant Professor of Medicine, Thoracic Oncology, Tisch Cancer Institute, Institute for Translational Epidemiology, Icahn School of Medicine, Mount Sinai Health System. In addition, Steven Fruchtman, MD, President and Chief Executive Officer of Onconova, will present a Company overview and detailed information from the Company’s Phase 2 rigosertib trial and the Company’s clinical strategy and near-term milestones.
Presentations will begin at 8:00 a.m. Eastern Standard Time. A live and archived audio and slide webcast of the event will be available on Onconova’s Corporate Events and Presentations page. Following the presentations, all speakers will be available for questions. This on-site event is open to analysts and institutional investors only.  Kindly RSVP in advance if you would like to attend in person, as space is limited. To request a spot, please send an email to ir@onconova.us.
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Novus gains on advancement of lead med

Thinly traded nano cap Novus Therapeutics (NVUS +14.9%) is up on average volume following its updates on clinical trials supporting lead drug OP0201.
Phase 1 trials: first dose cohort completed in adult safety and tolerability study (C-002). Screening for second higher dose cohort underway. Initial screening underway in single-dose safety and pharmacodynamics study (C-001). Data from both trials should be available in Q2. Enrollment completed in single-dose safety and preliminary efficacy study (C-004) in adults with acute otitis media (ear infection) with data expected later this quarter.
A Phase 2a study, C-006, in infants and children with acute otitis media has been added. Enrollment will commence in the coming weeks with topline results expected in H2.
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Small Rise in Hemoglobin A1c in Switch to Human Insulin in Type 2 Diabetes

Switching from analogue to human insulin is associated with a small increase in hemoglobin A1c (HbA1c) levels, according to a study published in the Jan. 29 issue of the Journal of the American Medical Association.
Jing Luo, M.D., M.P.H., from Brigham and Women’s Hospital in Boston, and colleagues examined the correlation between glycemic control and implementation of a health plan-based intervention of switching older adults with type 2 diabetes from analogue to human insulin. Data were included for 14,635 members who filled 221,866 insulin prescriptions over three years.
The researchers found that the start of the intervention correlated with a 0.14 percent overall HbA1c-level increase and a 0.02 percent slope change. No significant differences were noted in changes in the level or slope of mean HbA1c after completion of the intervention versus the intervention period. For serious hypoglycemic events, no significant correlation was found between the start of the intervention and the level or slope of change; no significant differences were seen in the level and slope for the postintervention versus the intervention period. No significant correlation was seen between the start of the intervention and a level or slope change for the rate of serious hyperglycemic events.
“Our study provides real-world evidence from clinical practice that should reassure patients, providers, and payors that it may be possible to switch to an older less expensive insulin to bring down costs while preserving quality of care,” Luos said in a statement.
Several authors disclosed financial ties to the pharmaceutical and medical device industries.
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