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Sunday, January 6, 2019

Ind. group aims to distribute nearly double naloxone doses in 2019


Local supplies of the opioid-overdose reversal drug naloxone increased and became more accessible to the public in 2018.
The Indiana Recovery Alliance reports it distributed more than 26,500 doses of naloxone last year and aspires to dispense 50,000 doses this year.
Of the 30,000 doses the IRA ordered in 2018 from drug-giant Pfizer, preliminary totals indicate the syringe-services program distributed 26,646. Most, but not all, of those doses were handed out in Monroe County, according to IRA director Chris Abert.
The IRA uses two different tracking sheets to count what they distribute, Abert explained.
There’s a daily tracking log for naloxone distributed from the IRA’s office, van and at training sessions. They use another log if the Bloomington harm-reduction program travels out of county for naloxone training sessions. The hand-tabulated logs get transferred to a digital spreadsheet; distribution totals are double-checked through invoices and inventory counts.
Orders for the antidote are placed every few weeks, so the IRA’s supply features several different expiration dates.
“Our goal is 50,000 in 2019, and we have secured the funding from private donations,” Abert said. “It’s helped us build the capacity to provide naloxone.”
Donations of all denominations have contributed to the IRA’s increased naloxone supply. In recent years, $10 donations have been made on the organization’s website, work groups have raised $10,000 gifts and an anonymous benefactor donated $100,000.
“We don’t spend a dime of taxpayer money on this program,” Abert said.
Local government does fund some naloxone distribution, however, through state and federal grants.
The Monroe County Health Department distributes naloxone to organizations, such as law enforcement agencies and Centerstone, that are registered with the Indiana Department of Health as naloxone providers. Partnerships are currently in the works with the Monroe County probation department and the IU Health Bloomington Hospitalemergency room.
Though it’s difficult to keep track of ultimately how much is passed out and used through the original supply at the Monroe County Health Department, administrator Penny Caudill said doses passed out are increasing. A new shipment recently arrived at the health department to replace a shipment of 500 from August. It’s been distributed.
Naloxone training is provided at the health department, 119 W. Seventh St., where anyone can ask to learn how to administer the drug, and take some with them.
“No one is required to take naloxone after they train. Someone could participate and say, ‘I’m not comfortable to do it quite yet,’ or hopefully they say, ‘Yes, I will take some in case I come across someone who might be overdosing,'” Caudill said.
Training is mandatory if naloxone is taken from the health department, and an appointment is required.
For 2019, the IRA has a goal of offering two naloxone training sessions in all 92 counties in the state, and the alliance will focus efforts on vulnerable populations.
“It’s important that we get the naloxone into the hands of the people who do drugs and their families,” he said.
Other organizations have partnered with IRA recently provide naloxone training.
In its first of four opioid-related events, the Greater Bloomington Chamber of Commerceinvited IRA to give training and pass out naloxone. Jim Inman, Chamber director of marketing communications, said about 25 kits were passed out at that event.
The opioid-overdose reversal drug comes in a variety of forms and prices.
Most expensive by far are the Evzio auto injectors, two dose kits complete with recorded audio instructions, by drug-maker Kaleo. FDA-approved in 2014, Kaleo has increased its price from $575 to more than $4,000 a kit.
Last March, Adapt Pharma offered its Narcan nasal spray at a cost of $37.50 a dose for police and fire departments, harm-reduction groups, schools and community centers. The drug maker’s website claimed the public interest price was at a 40 percent discount.
Naloxone the IRA purchases is among the least expensive because it is administered by way of intramuscular injection — tiny medicine vial, needle and syringe.
Abert said he was contractually obligated not to discuss the discounted pricing rates the IRA has worked out with Pfizer, which purchased naloxone manufacturer Hospira in 2015.
“When I do a price comparison about how much naloxone we can get out there, compared to the state and other organizations, it’s astounding,” he said.
The IRA started its syringe services program on Valentine’s Day 2016 after the Monroe County Health Department deemed increased rates of hepatitis C infections and heroin overdoses a public health emergency in August 2015. Long before that, volunteers with the harm-reduction program offered naloxone, sterile medical supplies and personal hygiene products.
The IRA’s naloxone inventory on Thursday consisted of about 3,000 intramuscular injection doses, 150 auto injector kits and a small supply of the nose spray.

DaVita started by Deutsche Bank


Deutsche Bank initiated coverage on shares of Davita (NYSE:DVA) in a report released on Thursday morning, MarketBeat Ratings reports. The firm issued a buy rating and a $60.00 target price

Physical therapy also can help prevent sports injuries


Physical therapy helps people recover from sports injuries, but it also can help prevent them.
This approach, called proactive physical therapy, can help correct imbalances in amateur and professional athletes that can increase the risk of injury, according to Dean Plafcan, a physical therapist with Penn State Health.
“Consider enlisting a physical therapist or athletic trainer to look for weaknesses or imbalances in one part of the body that might be impacting other areas,” Plafcan said in a university news release.
“The result of identifying problem areas and doing targeted therapy and training can be better athletic performance with less risk of pain and injury,” he added.
Plafcan noted that many amateur golfers complain about back pain, and the likely reason is their desk job. Spending a lot of time sitting leads to shortened hip flexors, the muscles on the front of the hip. This forces the lower back to do more of the work during a golf swing, resulting in pain.
“Proactive physical therapy can diagnose this imbalance and improve hip mobility,” Plafcan said. “The result is less risk of back pain, plus a more powerful downswing and greater yardage on the golf course.”
He also said that one-sided body use in many sports leads to physical imbalance.
“A baseball player, tennis player or golfer constantly works one side of the body more than the other, depending on whether the athlete is right-handed or left-handed,” Plafcan said.
“Yes, these athletes need great strength on their dominant sides to excel in their sport, but weakness on the other side of the body can lead to overcompensation and injury,” he explained. “By targeting exercise to increase symmetry in strength and flexibility, the athlete can improve overall performance.”
More information
The American Academy of Orthopaedic Surgeons offers sports injury prevention tips.
SOURCE: Penn State Health, news release, November 2018

NanoString Sees FY18 Revenue $83.5M, Exceeding High End of Guidanc


NanoString Technologies, Inc. (NASDAQ:NSTG), a provider of life science tools for translational research and molecular diagnostic products, today provided preliminary operational and financial results for the fourth quarter and fiscal year ended December 31, 2018.
“With 16% growth in our product and service revenue, 2018 was a year of renewed commercial momentum and strong execution as the investments we’ve made in our people and commercial processes began to pay off,” said NanoString president and chief executive officer, Brad Gray. “Customer demand for our GeoMx Digital Spatial Profiler (DSP) is exceeding internal expectations, resulting in a strong pipeline of pre-orders ahead of the planned launch. 2019 promises to be an exciting year, with the GeoMx DSP launch expected to accelerate our top-line growth in the second half of the year.”
Financial Highlights:
For the fourth quarter of 2018, product and service revenue is expected to be approximately $23.5 million, exceeding the upper end of the company’s guidance range of $22 to $23 million.
Product and service revenue for fiscal year 2018 is expected to be approximately $83.5 million, exceeding the upper end of the company’s guidance range of $82 to $83 million.
Total revenue for the fourth quarter of 2018 is expected to be approximately $30 million, including approximately $6 million of collaboration revenue, versus prior guidance of $28 to $29 million. Total revenue for fiscal year 2018 is expected to be in the range of $106 to $107 million, including approximately $23 million of collaboration revenue, versus prior guidance of $104 to $106 million.
Cash, cash equivalents and short-term investments totaled more than $90 million as of December 31, 2018.
Operational Highlights:
  • Approximately 135 nCounter® Analysis Systems were sold in 2018.
  • Installed base of approximately 730 nCounter Analysis Systems at December 31, 2018, an increase of approximately 20% since year-end 2017.
  • Shipped first beta GeoMx Digital Spatial Profilers during the fourth quarter.
  • Announced that the GeoMx Priority Site program was over-subscribed, yielding pre-orders for more than 30 instruments.
Brad Gray will give a corporate update at the JP Morgan Healthcare conference at 3:30 p.m. PST on Wednesday January 9th, 2019. A live webcast of the presentation will be available online from the investor relations page of the company’s corporate website at www.nanostring.com. After the live webcast, the presentation will remain available on the website for approximately 30 days.
These preliminary results are based on management’s initial analysis of operations for the quarter and year ended December 31, 2018 and are subject to further internal review and audit by the company’s external auditors.

CES 2019: Chinese tech firms lay lower amid trade tensions


The CES 2019 gadget show, which kicks off Sunday, will showcase the expanding influence and sway of China’s rapidly growing technology sector. But some of its firms are stepping back from the spotlight amid rising U.S. national-security concerns over Chinese tech and a trans-Pacific trade war launched by President Donald Trump.
Last year, a top executive of the Chinese telecom firm Huawei delivered a CES keynote address critical of AT&T’s abrupt cancellation of plans to sell a Huawei phone following espionage concerns raised by the U.S. government. This year, Huawei’s chief financial officer was arrested in Canada at the behest of the U.S.; Meng Wanzhou, daughter of Huawei’s founder, now awaits U.S. extradition . No Chinese technology executives will deliver CES keynotes in Las Vegas this week.
There are fewer Chinese entrepreneurs buying up booth space to show off their latest technology—more than 20 percent fewer exhibitors than last year, according to registration numbers tracked by the South China Morning Post. Chinese firms still account for more than a quarter of the conference’s 4,500 exhibitors, second only to the U.S. in sheer numbers. But some of the biggest names are taking a more subdued approach.
Internet company Baidu last year hosted a flashy event touting its self-driving software, but this year is sticking to a more conventional booth. E-commerce giant Alibaba is eschewing the big outdoor tent it helped erect last year in favor of quieter meetings marketing its voice assistant to business partners. The phone maker Xiaomi is simply skipping this year’s event altogether.
None of them are citing rising U.S.-China tensions, but it’s hard to ignore the geopolitical backdrop—even with a 90-day “cease-fire” on tariffs set to expire in March.
The U.S. and China have imposed import taxes on hundreds of billions of dollars of each other’s goods—and Trump has threatened more to come, including tariffs that could make devices like iPhones more expensive. The U.S. is also exploring new export restrictions that would target industries where China is hoping to get ahead, such as artificial intelligence and robotics. And the Justice Department brought charges last month against two Chinese citizens it accused of stealing American trade secrets and other sensitive information on behalf of Beijing’s main intelligence agency.
Of course, plenty of Chinese entrepreneurs are still eager to show off their innovations. Hosts of the 52-year-old trade event have sought to downplay the tensions, noting that they’ve weathered previous trade tensions, such as those that roiled U.S.-Japan relations in the 1980s.
CES 2019: Chinese tech firms lay lower amid trade tensions
In this Jan. 9, 2018, file photo the Huawei Mate10 Pro phone is displayed at the Huawei booth during CES International in Las Vegas. The CES 2019 gadget show, which kicks off Sunday, will showcase the expanding influence and sway of China’s …more
“The Japanese presence used to be very big and it was similar in that the U.S. was in a panic about it,” said Gary Shapiro, CEO of the Consumer Technology Association, which organizes CES. That ended when the Japanese “bubble” economy burst in 1991 and its tech industry began a long, slow decline.
“Japanese innovation from those companies shrunk and those companies consolidated,” Shapiro said. “These things are impermanent. So I don’t lose that much sleep over it.”
Shapiro said the trade dispute with China and the Meng arrest in Canada aren’t impacting attendance. CES organizers on Sunday wouldn’t confirm numbers showing a sharp drop in Chinese exhibitors, but said a decline in small Chinese companies on the show floor was made up by expanded booth presence from bigger firms.
Chinese tech firms are increasingly joining their American, South Korean and Japanese counterparts in using CES to build enthusiasm for up-and-coming electronics products, while also connecting with potential new international partners and suppliers. That’s especially true for electronics firms like Hisense and TCL, which have increasingly sought to sell their TVs in North America, and Lenovo, which is already a big player in the U.S. laptop market but is pushing to sell other internet-connected devices.
Hisense is making a splashier presentation this year as it invests in boosting its U.S. brand awareness, said Jim Ninesling, head of marketing for Hisense USA. Previously, the company, which has a large market share in China, mostly kept on the U.S. sidelines, branding some of its products under the name of the better-known Japanese firm Sharp.
Chinese electric carmaker Byton, a startup backed by internet giant Tencent, on Sunday is promising to unveil what it calls the “world’s most intuitive automotive interface,” which, according to a tease on Twitter , involves a touchscreen mounted on the steering wheel. AI firm iFlytek—sometimes described as China’s Siri or Alexa—is planning to showcase its latest advances in voice recognition and real-time translation services.
And a startup expo co-hosted by the Chinese government features a bevy of gee-whiz innovations, from indoor delivery robots and portable karaoke headsets to “smart” suitcases aided by computer vision.
CES 2019: Chinese tech firms lay lower amid trade tensions
In this Jan. 9, 2018, file photo a woman wears Huawei VR2 goggles at the Huawei booth during CES International in Las Vegas. The CES 2019 gadget show, which kicks off Sunday, will showcase the expanding influence and sway of China’s rapidly …more
In an ideal world, the tech industries in the two countries would be seen as complementary, said venture capitalist Kai-Fu Lee, who led Google’s subsidiary in China before the company withdrew over censorship and other concerns.
“The U.S. strength is deep technologists, universities, academics, people with superior experience,” he said. “China’s superiority is a larger market, more data, and very tenacious and hardworking entrepreneurs.”
Lee said his optimism for a more collaborative approach is now “merely a dream” because of the worsening trade dispute. But he said there could still be partnerships between U.S. firms and Chinese companies that, for now, mostly cater to Chinese consumers.
“Google feels much, much more threat from Amazon than any Chinese company,” he said. “That makes Tencent and Alibaba potential allies, especially when customer needs cross international boundaries.”

Neurocrine expects Q4 net product sales of $130M


Neurocrine Biosciences (NBIX) provided an update on its business performance, including preliminary net product sales results for 2018, and key clinical development programs for 2019. Kevin Gorman, Chief Executive Officer of Neurocrine, will discuss these updates as part of a webcast presentation at the 37th Annual JPMorgan Healthcare Conference in San Francisco on Monday. Based on preliminary unaudited financial information, the Company expects net product sales for the three months and full-year ended December 31, 2018 to be approximately $130M and $409M, respectively, compared to $64.5M and $116.6M for the same periods in 2017. Regarding 2019 milestones, the company expects “Talk About TD” disease state awareness campaign; execution of post-marketing clinical studies, including RE-KINECT; presentations at key scientific annual meetings; elagolix in collaboration with AbbVie (ABBV); continued launch of ORILISSA to treat endometriosis by AbbVie; Elagolix for uterine fibroids: planned 2019 New Drug Application submission Opicapone for Parkinson’s Disease; preparation for 2020 opicapone commercial launch; Phase IIa data for CAH – adults – in Q1 2019; Phase IIa initiation for CAH – pediatric – in Q2/Q3 2019; Pivotal study initiation for CAH – adults – in 2H 2019, pending Food and Drug Administration discussion in Q2; Investigational New Drug submission and initiation of a Phase I trial for a new, internally discovered program.

Exact Sciences expects FY18 revenue of $454M-$455M, consensus $438.39M


Exact Sciences expects to report Q4 revenue between $142.5M-$143.5M, an increase of 64% percent from the same quarter of 2017. Consensus at $126.98M. The company completed approximately 292,000 Cologuard tests during the fourth quarter of 2018, which represents 66% growth from the same period of 2017. For full-year 2018, the company anticipates reporting total revenue between $454M-$455M, a year-over-year increase of 71%. Consensus at $438.39M. Completed Cologuard test volume during 2018 was approximately 934,000 tests, a 64% increase from 2017. Nearly 15,000 health care providers ordered Cologuard for the first time during the fourth quarter of 2018. The number of providers who have ordered Cologuard since its launch increased to nearly 147,000 during 2018. Exact Sciences has not completed preparation of its financial statements for Q4 or FY18. The company plans to report 2018 financial results and provide guidance during its February 2019 earnings call.
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