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Sunday, December 1, 2019

Portable photoacoustic breast imaging system shows promise in initial lab tests

A new, portable breast imaging system under development in Buffalo has the potential to better identify breast cancer in women with dense breast tissue.
That is among the findings of a study published in the journal IEEE Transactions on Biomedical Engineering in August.
The study was led by University at Buffalo researchers in collaboration with Roswell Park Comprehensive Cancer Center and Windsong Radiology.
“We’re developing a new imaging system—it’s called a Dual Scan Mammoscope—that combines light and ultrasound technology. We believe it has the potential to help detect  earlier, thereby increasing ,” says UB researcher and the study’s lead author, Jun Xia.
Xia, Ph.D., is an assistant professor in the Department of Biomedical Engineering, a joint program of the School of Engineering and Applied Sciences and the Jacobs School of Medicine and Biomedical Sciences at UB.
Regular mammograms are the best tests doctors have to find  cancer early, according to the Centers for Disease Control and Prevention. However, they are less effective for women with dense breast tissue.
There are alternatives methods in such cases, including MRI. But MRI tests are costly, they require intravenous contrast agents that can cause , and they’re not easily portable.
The Dual Scan Mammoscope, or DSM, is similar to a mammogram, in that patients stand upright to have their breast compressed for imaging. Unlike mammograms, however, the DSM requires only mild compression of the breast, likely reducing the severity of pain that women can experience pain during the procedure.
Unlike a mammogram, the DSM is a radiation free-test. It uses a laser to illuminate breast tissue. In turn, this generates acoustic waves that are measured by ultrasound technology. The combination of lasers and ultrasound is an  called photoacoustic tomography.
While MRI requires a contrast agent, the DSM test uses hemoglobin, a protein in red blood cells that carries oxygen throughout the body. The technology Xia and his colleagues are developing features two simultaneous scans, one working from the bottom of the breast while the other works from the top.
The design, Xia says, ensures optimal light delivery and acoustic detection, enabling imaging deep into breast tissue. It’s also portable; for example, it could easily fit into mobile mammogram units.
In initial laboratory tests, the research team imaged breast sizes B, D and DD. The study highlights the D breast test, which shows imaging through 7 centimeters—the first time a photoacoustic system produced imaging that deep, the research team believes.
Xia says the DSM method shows promise in detecting tumors in the sub-millimeter range, provided they exhibit sufficiently developed blood vessels.
The team plans additional studies, including the imaging of more patients with different breast sizes and tumor characteristics, to ensure the DSM machine’s effectiveness.

Explore further

More information: Nikhila Nyayapathi et al. Dual Scan Mammoscope (DSM)—A New Portable Photoacoustic Breast Imaging System with Scanning in Craniocaudal Plane, IEEE Transactions on Biomedical Engineering (2019). DOI: 10.1109/TBME.2019.2936088

Kid challenges Trump to go vegan for $1M donation to veterans

This 9-year-old wants to make a deal with Donald Trump: Go vegan for the month of January, and he’ll donate $1 million dollars to veterans.
The brazen fourth-grader from Melbourne, Fla., made the bold offer Sunday morning in a series of advertisements planted on billboards, television spots and print media.
“He’s the president of our country, and pretty much everyone wants a healthy president,” Evan, a self-proclaimed vegan and animal-rights activist, told The Post. (His last name is being withheld because of his age.)
And if President Trump doesn’t accept Evan’s offer? That’s a $1 million donation down the drain for veterans. Evan is confident Trump will be able to put his love for fast-food burgers aside for the cause.
“I think that Trump really cares about our veterans [because] they’re the ones who fought and continue to fight for our country,” he said.
The precocious grade-schooler says he chose Trump since he has the power to inspire others.
“If people saw him do this, then everyone would hear about it and say, ‘If President Trump did it, maybe I can do it?’ ” Evan said.
The cash, of course, won’t be put up by Evan himself, but by the nonprofit he’s representing called Million Dollar Vegan, which seeks to fight “climate change with diet change.”
The vegan advocacy group — which was behind a similar stunt earlier this year that challenged Pope Francis to try a plant-based diet for Lent — said they’ll be ready to cash out within one hour if the president agrees on Twitter.
“The donations for this cause are now in escrow,” a press release states. The organization has support from celebs such as Paul McCartney, Moby and Woody Harrelson, and the charitable arm of environmental investment firm Blue Horizon Corporation.
Evan’s ad features the defiant fourth-grader crossing his arms next to a letter he penned to the president.
“Now, I know what you’re thinking,” the letter reads. “Why would I do that? Well, we want to Make America Healthy Again, and a plant-based diet can prevent, treat and even reverse many serious diseases …”
The letter goes on to list illnesses, including heart disease, type 2 diabetes and obesity, which some studies have shown could be mitigated by a plant-based diet.
“It’s really good for your body,” Evan said of the eating lifestyle. “It helps you every day, and you can wake up and feel amazing.”
Despite not being able to eat ice cream, cake or pizza, Evan says he absolutely “loves everything about” being vegan.
“I like that you can eat a meal … and animals don’t have to be hurt and the planet doesn’t have to be hurt,” he said, adding that cashew-cheese quesadillas are his favorite food.
Evan went vegan when he was only 5 years old, and has since amassed more than 15,000 followers on his Instagram account, which is run by his mom. He also sells his own vegan-inspired merch, including “powered by plants” and “animal defender” baseball caps on his website.
Veterans, doctors and Olympic women’s track cycling silver medalist Dotsie Bausch all agreed to back Evan’s plea, according to a statement released by Million Dollar Vegan.
“The president is under significant daily stress and would benefit from this diet change,” cardiologist Joel Kahn says in the release.
And if giving up well-done steaks is any worry for Trump, he should rest assured, Evan says.
“As a token of our gratitude, we would be delighted to provide delicious plant-based versions of all your favorite foods for you personally at the White House,” he says.

Private-Equity Cash Piles Up as Takeover Targets Get Pricier

U.S. private-equity firms, armed with a record amount of cash, are struggling to find ways to spend it.
A year ago, fears of an economic slowdown and worries about trade tensions with China sent a tremor through markets and put some leveraged buyouts on hold. But while stocks rebounded in the new year, buyout activity never fully recovered.
The aggregate value of U.S. buyouts fell 25% year to date through October, compared with the same period a year earlier, according to data provider Preqin. Deals totaled $155.2 billion during the first 10 months of the year — the lowest since 2014.
Private-equity firms traditionally seek to buy up companies they see as undervalued, cut costs or spruce them up to spur growth and sell them or take them public a few years later. With U.S. equity markets surging, already expensive takeover candidates have gotten even pricier, making many of them too rich for even the most optimistic private-equity buyer. Meanwhile, would-be corporate acquirers whose stock prices have run up this year can use their shares as a deal currency, giving them an edge over financial buyers in most auction processes.
The restraint buyout firms are showing suggests a level of discipline that wasn’t present during the last market peak in 2007, when they struck $365.9 billion worth of deals in the U.S. Many of the companies they bought then struggled during the ensuing global financial crisis, and a number have filed for bankruptcy protection.
The drop in deal activity comes as private-equity firms’ unspent cash dedicated to North American buyouts reaches a record $771.5 billion, up nearly 24% since the end of last year and more than double where it stood at the end of 2014, Preqin data show.
A potential buyout of Walgreens Boots Alliance Inc. that KKR & Co. had considered in recent months shows some of the challenges facing private-equity firms. Financing such a deal would always have been tough given Walgreens’ market value of more than $50 billion, but the math has become even more difficult as loan buyers have begun pushing back on what terms they are willing to accept. The parties haven’t been in the same ballpark on valuation, and no deal appears imminent, people familiar with the matter said.
Investors such as pension funds, sovereign-wealth funds and insurance companies have poured money into private markets in hopes of achieving higher returns than those offered by traditional stocks and bonds in an era of low interest rates. Private-equity firms will need to invest that money to satisfy their investors and to begin earning lucrative management fees on it.
U.S. buyout volume may not bounce back next year either, even if the stock market cools off. With an election looming, private-equity investors say uncertainty around monetary, fiscal and regulatory policy — as well as already heightened scrutiny of their industry from Democratic presidential candidates — will cause them to tread carefully.
Some firms have found unique ways to navigate high prices. Blackstone Group Inc. has focused its deal making around investment themes where it is particularly bullish. These include the growth of e-commerce, which has driven its massive purchases of warehouse portfolios, and the ongoing value of live entertainment as more activities move online, motivating its deal for theme-park operator Great Wolf Resorts Inc. Apollo Global Management Inc. has been buying public companies it thinks the market has undervalued by favoring those with faster growth.
Not all areas of the buyout market have slowed. Globally, deal volume is pacing roughly where it was last year. And certain pockets of the U.S. market remain robust. Firms that invest in business software, for example, have kept up their deal-making pace, thanks in part to the proliferation of targets.
“In our space, given that many companies lack profitability, they can be highly volatile,” Orlando Bravo, founder and managing partner of software-focused firm Thoma Bravo LLC said in an interview. “So when their revenue growth slows or they miss numbers, that can provide opportunities.”
The buyout malaise has spread to banks, whose revenue from leveraged finance fell nearly 19% year over year in the first three quarters of the year, according to Dealogic. New issuance of leveraged loans — commonly used to finance buyouts — have tumbled. High-yield bond issuance, another source of deal financing, has climbed, but bankers say much of that has been driven by less remunerative refinancing activity.
Making things more difficult for private-equity firms, the financing market has tightened in recent months. As interest rates have fallen, there have been big outflows from mutual funds that purchase buyout loans that banks carve up and sell. That has made deal financing more dependent on collateralized loan obligations, or CLOs — complex vehicles that buy bundles of below-investment-grade corporate loans.
CLOs, which have historically constituted about 60% to 65% of the market for buyout loans, now represent 72% of the allocations for newly issued leveraged loans, according to a recent report by analysts at Goldman Sachs Group Inc. Creation of new CLOs is also trailing 2018 by 9.5%, the analysts wrote.
That becomes an issue because CLOs, which are typically issued by the credit arms of private-equity firms and banks, have limits on the number of low-rated loans they can own. After years of steadily filling up their tanks with buyout loans, they are now pushing back on the loose credit agreements and borrower friendly terms they once accepted amid worries about rising loan downgrades.
In some cases, that has left banks holding the bag and has raised borrowing costs for private-equity firms, forcing them to lower their return expectations for deals.
Banks in October struggled to sell about $2 billion in debt to fund Apollo’s purchase of online-photo service Shutterfly Inc. and ended up agreeing to buy up to $280 million themselves, The Wall Street Journal reported.

How Big-Box Retailers Can Revitalize Rural Health Care

There’s a surefire, and perhaps unlikely, way to bolster access to health care for underserved Americans—at the shopping mall.
Millions of Americans struggle to get affordable, timely medical care. Roughly one-quarter of rural Americans haven’t been able to get needed care at some point in recent years, according to a May 2019 poll conducted by NPR, the Robert Wood Johnson Foundation, and the Harvard T.H. Chan School of Public Health.
Retailers can help overcome these barriers. In many rural communities, the local Walmart or CVS is not just an economic anchor but a civic institution. It’s a gathering place for far-flung residents. And it may be the most convenient place for historically underserved populations to seek health care.
Adding telehealth capabilities to our existing retail infrastructure could significantly expand access to top-notch care—and reduce costs for patients and the healthcare system.

Retail health clinics—low-cost health providers capable of treating minor ailments like fevers, colds, rashes, strep throat, and the like—have proliferated across the country. From 2006 to 2017, the number of clinics jumped from just 350 to 2,800.
It’s easy to see why. For one, they’re less expensive than conventional healthcare facilities. A retail clinic visit is about 30% to 40% cheaper than a trip to the doctor, according to research conducted by a professor at Harvard. It’s 80% less expensive than going to the emergency room.
Consider those savings in real dollars. In Massachusetts, an average visit to a retail health clinic costs just $69—about $830 less than the average ER visit.
What’s more, retail clinics typically publish their prices upfront. So patients can shop around. And they won’t be hit with surprise medical bills.
Retail clinics are convenient, too. They tend to be near where people conduct routine errands. They certainly offer longer hours than the typical doctor’s office. Most don’t require appointments. Indeed, about half of people cited “hours were more convenient,” “no need to make appointment,” and “location was more convenient” as major reasons they chose a retail health clinic in a recent survey from the Robert Wood Johnson Foundation.
There’s still a tremendous potential market for retail clinics. Consider the sheer number of potential locations. Kroger has more than 4,000 stores nationwide. Walmart has nearly 5,000. CVS Health has about 10,000.
Yet Walmart currently runs clinics in just three states. CVS’s MinuteClinic brand operates in about 1,100 locations.
If even a fraction of these stores added health clinics, millions of Americans would be able to access care more easily. After all, 90% of the country lives within a 15 minute drive of a Walmart.
The need for more healthcare infrastructure is certainly acute. Nearly 80 million people live in federally designated Health Professional Shortage Areas. Many of those areas are rural.
Adding telehealth capabilities to a more robust network of retail clinics would maximize their impact. Previously isolated patients could head to their local big-box retailer to connect with top-flight specialists miles away via videoconference. Clinics could even outfit patients with devices to monitor vital signs remotely—and then transmit the data back to their distant specialists.
Fortunately, retail clinics are starting to incorporate telehealth in their offerings. Rite Aid, for example, is installing kiosks in its clinics that connect patients with remote care. With the help of a medical assistant, the kiosk records patients’ vital signs and answers to a medical survey. Then, the patient is connected to a remote physician, who develops a treatment strategy.
CVS is enabling patients to get treatment for minor illnesses, injuries, or skin conditions from their homes. Using the CVS Pharmacy app, patients can connect to a provider in their state via video at any time of the day.
Deploying the latest telehealth technology across our existing retail infrastructure could cost-effectively address the healthcare gaps that afflict rural and other underserved communities.

Biotech week ahead, Dec. 2

Biotech stocks advanced in the holiday-shortened week, with upside driven mainly by the broader market strength. Reflecting the extreme volatility in the space, a few stocks gyrated wildly in reaction to catalytic events.
ChemoCentryx Inc CCXI 1.92% nearly tripled in a single session in reaction to positive Phase 3 data for drug to treat rare inflammatory disease.
Invest in IPO shares before the stock hits the market with ClickIPO. Check it out here
The Medicines Company MDCO 0.18% was another standout gainer, adding about 22% Monday, on a deal to be bought by Novartis AG NVS 0.29%.
Here are the key catalysts for the unfolding week.

Conferences

  • International Alliance of Amyotrophic Lateral Sclerosis/Motor Neurone Disease, or ALS/MND, Annual Meeting – Dec. 1-2 in Perth, Australia
  • 34th World Cardiology Conference – Dec. 2-3 in Barcelona, Spain
  • Annual Congress on Antibiotics and Antimicrobial Resistance – Dec. 2-3 in Paris, France
  • 6th Annual Conference on Stroke and Neurological Disorders – Dec. 2-3 in Rome, Italy
  • 10th International Conference on Immunology & Immunogenetics – Dec. 2-3 in London
  • 12th Clinical Trials On Alzheimer’s Disease, or CTAD – Dec. 4-7 in San Diego, California
  • Piper Jaffray 31st Annual Healthcare Conference – Dec. 3-5 in New York City
  • Evercore ISI HealthCONx Conference – Dec. 3-5 in Boston, Massachusetts
  • 2nd Global Conference on Cardiovascular Research and Clinical Cardiology – Dec. 6-7 in Montreal, Canada
  • American Epilepsy Society, or AES, 2019 Annual Meeting – Dec. 6-10 in Baltimore, Maryland
  • 61st American Society of Hematology, or ASH, Annual Meeting – Dec. 7-10 in Orlando, Florida

PDUFA Dates

The FDA is scheduled to give its verdict on Roche Holdings AG Basel ADR’s RHHBY 0.05% Tecentriq in combination with Bristol-Myers Squibb Co’s BMY 1.16% chemo medications Carboplatin and Abraxane in patients with metastatic non-squamous NSCLC, who do not have EGFR or ALK genomic tumor aberrations. The PDUFA action date is fixed for Monday.

Clinical Readouts

CTAD Presentations

ACADIA Pharmaceuticals Inc. ACAD 3.64% – detailed Phase 3 data for pimavanserin in dementia-related psychosis (Wednesday)
Biogen Inc BIIB 1.17% – Detailed data from the Phase 3 EMERGE study of aducanumab in Alzheimer’s disease (Thursday)
Cassava Sciences Inc SAVA 2.78% – Phase 2a data for PTI-125 in Alzheimer’s disease (Thursday)
Alector Inc ALEC 1.48% – Phase 1 data for AL002, a monoclonal antibody, in Alzheimer’s disease (Friday)

International Alliance of ALS/MND Annual Meeting Presentations

Cytokinetics, Inc. CYTK 1.04% – Responder and subgroup analyses of data from the Phase 2 study of Reldesemtiv in ALS (Thursday)

AES Annual Meeting Presentations

GW Pharmaceuticals PLC- ADR GWPH 1.67% – Phase 3 data for Epidiolex in tuberous sclerosis leukemia (Saturday)

ASH Presentations

(Scheduled for Saturday)
Magenta Therapeutics Inc MGTA 0.53% – initial Phase 1 data for MGTA-145 in healthy volunteers
Bristol-Myers Squibb – Phase 1 data for liso-cel, or JCAR017, in relapsed/refractory B cell non-Hodgkin lymphoma
Fortress Biotech FBIO 4.57% and Mustang Bio Inc MBIO 9.69% – Phase 1/2 data for MB-107 in X-linked severe combined immunodeficiency
Sierra Oncology Inc (NASDAQ: SRRA – Phase 3 data for momelotinib in myelofibrosis
Actinium Pharmaceuticals Inc ATNM 17.9% – Phase 3 data for lomab-B in acute myeloid luekemia
bluebird bio Inc BLUE 0.86% – Phase 1/2 data for LentiGlobin in sickle cell disease
Morphosys Ag MOR 0.2% – Phase 2 data for MOR208 and Gilead Sciences, Inc. GILD 0.18%‘s Zydelig in chronic lymphocytic leukemia Unum Therapeutics Inc UMRX 0.75% – Phase 1 data for ACTR707 with Roche’s Rituxan in CD20 positive non-Hodgkin lymphoma and Phase 1 data for ACTR087 plus Rituxan, also in non-Hodgkin lymphoma
Verastem Inc VSTM 3.79% – Phase 2 data for duvelisib in peripheral T-cell lymphoma
Autolus Therapeutics Ltd – ADR AUTL 4.97% – interim Phase 1 data for AUTO3 in relapsed/refractory diffuse large B-cell lymphoma and updated Phase 1 data for AUT01 in acute lymphoblastic leukemia
TrovaGene Inc TROV 1.42% – Phase 1/2 data for ovansertib in acute myeloid leukemia
Cyclacel Pharmaceuticals Inc CYCC 3.77% – initial Phase 1 data for CYC065 plus AbbVie Inc ABBV 0.66%‘s venetoclax in chronic lymphocytic leukemia
Oncternal Therapeutics Inc ONCT 6.67% – Phase 1/2 data for cirmtuzumab plus AbbVie’s ibrutinib in chronic lymphocytic leukemia and mantle cell lymphona
Sangamo Therapeutics Inc SGMO 0.37% – Phase 1/2 data for SB-525 in hemophilia A
Acceleron Pharma Inc XLRN 1.05% and Bristol-Myers Squibb – Phase 2 data for luspatercept in hemophilia A

IPO Quiet Period Expirations

Centogene N.V./EQ CNTG 2.82%
Galera Therapeutics Inc GRTX 0.32%
TELA Bio Inc TELA 15.19%
CNS Pharmaceuticals Inc CNSP 1.2%
89bio Inc ETNB 3.82%

Cost-saving NHS plan will ‘ration’ tests and treatments for millions

The NHS is planning to “ration” dozens of common tests and treatments which will impact millions of people in England.
The health organisation has prepared a list of 34 tests and treatments which patients in England will only be granted access to in rare circumstances if plans go ahead, the Guardian reported .
Millions of patients will no longer be permitted to have X-rays on their sore backs, hernia repair surgeries pr scans of their knees to detect arthritis under the new controversial NHS plans which will see doctors ration “unnecessary” treatment.
Future patients in England will only be allowed access to these tests in exceptional circumstances.
If the plan is implemented, it will represent an unprecedented restriction of patient’s access to procedures.
The NHS scheme would also see patients advised to use physiotherapy or painkillers to dull the pain of an arthritic knee rather than undergo an exploratory operation called an arthroscopy.
Other types of surgery including some CT and MRI scans and some blood tests are also on the list.
Millions of patients could be impacted by the clampdown on 34 diagnostic tests (Image: Getty Images)
An NHS spokesman told the Guardian the plan had not been approved or implement, adding there was “strong support from senior doctors in the Academy of Medical Royal Colleges for action to eliminate wasteful interventions that don’t benefit patients”.
Rachel Power of the Patients Association said the plan, if implemented, could lead to patients having to suffer the pain of their condition or pay for private health remedies.
She said a range of NHS treatments had been cut back in recent years.

Ms Power said: “Often there are good reasons for not using these ‘low-value’ treatments as a first choice, but they are appropriate for some patients.
“We are unhappy at any new barriers being erected between patients and the treatments they need.”
Some blood tests could be rationed as part of new NHS cost-cutting plans (Image: Getty Images)
    The 50-page NHS plan is the result of months of detailed secret discussion but has now been revealed.
    Many medical professionals believe these interventions should be scrapped or used sparingly, because they can put patients in danger or make them anxious.
    The four medical bodies were reportedly prepared to publish proposals this month but were forced to delay in accordance with purdah rules.

    UPS employees busted in massive drug scheme

    A group of UPS (NYSE:UPS) employees allegedly helped to import and traffic massive amounts of drugs and counterfeit vaping oils from Mexico during the past decade, the Washington Post reports.
    The scheme exploited a vulnerability in the company’s distribution system, according to police, and at times involved moving thousands of pounds of marijuana and narcotics each week.
    Standard cardboard boxes were carefully routed through UPS’s trucking and delivery systems, and obscured the origin and destination of drug shipments.