Friday, December 28, 2018
Mayor de Blasio says Con Ed evaluating outages after fire in Queens, NY
NYC Mayor Bill de Blasio said via Twitter: “Light was caused by electrical surge at a substation. No current fire, no injuries. MTA has power, but there are delays on the 7 train. Power coming back on at LGA, but expect delays. Con Ed evaluating outages now.”
https://thefly.com/landingPageNews.php?id=2841739
Vertex: Positive Phase 2 Data in Third Proof-of-Concept with VX-150
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced positive results of a Phase 2 study of the investigational NaV1.8 inhibitor VX-150 in patients with pain caused by small fiber neuropathy. The study met its primary endpoint and showed that treatment with VX-150 demonstrated statistically significant and clinically meaningful pain reduction, as measured by the within-group change from baseline in the weekly average of daily pain intensity on the 11-point numeric rating scale (NRS) at Week 6. VX-150 was generally well tolerated in this study (see also Vertex Pharmaceuticals Incorporated).
This Phase 2 study in patients with small fiber neuropathy is the third positive proof-of-concept study for VX-150 and provides further validation of the potential role of NaV1.8 inhibition in the treatment of multiple pain conditions. A Phase 2b dose-ranging study of VX-150 following bunionectomy surgery is currently ongoing to support potential pivotal development. Additionally, the company is advancing multiple pain molecules through late-stage preclinical development and anticipates initiating clinical development with the first of these molecules in 2019.
“We are excited to now have three positive proof-of-concept studies that validate the potential role for NaV1.8 inhibitors to treat a variety of pain conditions,” said Jeffrey Leiden, M.D., Ph.D., Chairman, President and Chief Executive Officer of Vertex. “These results show a potential path for the treatment of pain at a time when there is great clinical and societal need for new medicines. We continue to progress VX-150 toward pivotal development and also plan to advance additional NaV1.8 pain medicines into clinical development beginning in 2019.” About the Phase 2 Study in Patients with Small Fiber Neuropathy The data announced were from a Phase 2, randomized, double-blind, placebo-controlled, 6-week study that evaluated treatment with VX-150 (n = 46) or placebo (n = 43) in patients with chronic pain caused by small fiber neuropathy. In this study, 1250mg of VX-150 was dosed orally every 24 hours. Efficacy Results The study met its primary endpoint, showing a statistically significant mean within-group change from baseline of -2.02 points for those treated with VX-150 in the weekly average of daily pain intensity on the 11-point NRS, as reported in the daily diary, at Week 6 (p<0.0001). The mean within-group change from baseline for those treated with placebo was -0.93.
A second pre-specified analysis compared those patients randomized to VX-150 or placebo. This analysis demonstrated a treatment difference in the mean change from baseline of -1.09 (95% CI: -1.88 to -0.29) in the weekly average of daily pain intensity on the 11-point NRS, as reported in the daily diary, at Week 6. This treatment difference was observed as early as Week 1, and was sustained through the six-week treatment period.
Thursday, December 27, 2018
Amazon gets into health insurance — and more 2019 health-tech predictions
The health-technology industry is wrapping up a marquee year.
Start-ups in the space got record levels of funding from venture capitalists, and the second half of the year featured some notable acquisitions, including ResMed’s $225 million purchase of Propeller Health this month.
Large technology companies such as Apple and Amazon explored opportunities to get their products into the medical sector, and they made some important hires along those lines. In response, traditional health-care companies, including pharmaceutical makers and health plans, forged their own partnerships with tech developers to help them modernize their offerings and improve the consumer experience.
That’s all in the rearview mirror now. What’s likely to happen in the year ahead?
CNBC asked a dozen experts from across the health-care industry for their predictions. Here are their top picks:
Wearables will track blood pressure
In 2018, the Apple Watch introduced an electrocardiogram to monitor a user’s heart rhythm and look for potential irregularities, including a type of arrhythmia known as atrial fibrillation. The company got clearance from regulators for the new ECG feature.
What’s next?
These recent additions to the Apple Watch “will start a serious health feature arms race for all the makers of wearables,” said David Albert, a cardiologist and the co-founder of AliveCor, a wearables company that specializes in heart health. In other words, companies such as Samsung and Alphabet will likely have to step up with breakthroughs of their own.
And all that might lead to some major innovation in 2019 that would impact millions of people. One might be for a company to figure out a way to track blood pressure, or a proxy for it, without a cuff, suggests Walter De Brouwer, CEO of a health software start-up called Doc.Ai. De Brouwer previously worked on biomedical sensor technology. Many companies have failed to get a product like this to market, but De Brouwer said that “now is the ideal time.” A variety of factors will make it possible in 2019, he said, including the increasing openness of regulators to new ideas, coupled with some recent improvements in sensors and algorithm-based technology.
If a company such as Apple does that, he says, they’ll come into the following year “owning the new vital signs of the twenty-first century.”
A lot of new tech hits Medicare Advantage
Most people don’t associate health plans with innovation. But the executives behind a growing crop of “Medicare Advantage” plans are hoping to change that.
As baby boomers age into Medicare, many are opting to receive benefits through private plans approved by the government, known as Medicare Advantage. These plans have been among the fastest to adopt new technologies, in part because of the way they get paid. They typically make money by taking on the risk of caring for a population, and the most successful among them will invest in keeping their members as healthy as possible.
Sachin H. Jain, CEO of Anthem-owned health system CareMore Health, said 2019 will be a big year for partnerships between technology companies and MA plans. For instance, CareMore was among the first plans to start working with Lyft this past year, meaning it agreed to cover Lyft rides for seniors who needed help getting to the doctor’s office. Next year, he said, he plans to meet with more technology companies that can keep his population healthier while lowering costs.
“I think tech has gotten more sophisticated with wearables and the proliferation of new devices, as well as the enhanced sophistication of cell phones,” he said. “We can do a lot to remotely monitor people now.”
The one caveat? Jain said that technologists will need to refine their pitch to help insurers reach the right population. Not everyone will benefit from a wearable that tracks potential heart problems, he said, but some would.
“My biggest concern is how do we make sure we are getting to just the right patients who would benefit the most,” he said.
Amazon gets into health insurance
Understanding Amazon’s overarching strategy for health care, assuming it has one, is a process that requires putting a lot of puzzle pieces together. In 2018, those closely following Amazon’s moves got a few big hints that might indicate a larger and more ambitious plan. To recap, Amazon bought an internet pharmacy called PillPack; it formed an employer health coalition with J.P. Morgan and Berkshire Hathaway, and it offered a big discount on Prime to low-income Medicaid recipients.
What does all this mean?
Well, according to at least one industry expert, it suggests that Amazon will make a very bold play like getting into health insurance in 2019.
“In my opinion, the puzzle is far from complete,” said Stephen Buck, co-founder of Courage Health, a health transparency company. “2019 could be the year that Amazon adds a few more big pieces to reveal much larger ambitions in health care by becoming an insurer, pharmacy benefits manager, or both,” he said.
Buck said this might be a necessity for Amazon, especially with pharmacy benefits managers — the middlemen that manage prescription drug benefits — integrating with insurers in 2018, such as CVS and Aetna, or Cigna and Express Scripts. That might force Amazon to offer its own integrated system, which it could test with its own employees first before it approached other large employers.
Pharma companies flex their buying muscle
Pharmaceutical companies will be on the hunt for innovators to add to their portfolio, whether it’s biotech upstarts, artificial intelligence start-ups or digital health companies, said Daphne Zohar, CEO of a biopharma company called PureTech Health.
Zohar, who teams up with pharma companies through her work at PureTech, said the hot new role in pharma is the chief digital officer. And many of these newly hired execs will work closely in 2019 with technologists and entrepreneurs. Many drugmakers are also looking at innovators to bring in-house through acquisitions so they can fuel “big science areas that they feel they are missing out on,” she said, as well as tap into the potential of new technologies that can track how their drugs are faring once they hit the market.
It’s also a good time for acquisitions, she said.
“With the recent market correction, we may have reached a sweet spot for M&A activity and this could be the year for multiple big transactions,” Zohar said.
Funding will flow into tech for mental health
Mental health got a lot of attention in 2018, particularly with the high-profile suicides of Kate Spade and Anthony Bourdain. What became clear this year is that a lot of people struggle with mental health challenges, but there aren’t ample resources and services to care for them.
Can technology fill the gap?
In 2019, one mental health expert said, there will be new research on how technologies that are widely used by consumers can track conditions such as depression and anxiety. For instance, a Silicon Valley start-up called Mindstrong Health is attempting to use the smartphone keyboard to pinpoint behaviors that might be indicative of depression. For that reason, “the breakout companies will look less like mental health tech, and more like tech that creates efficiencies in the background,” said Sarah Seegal, co-founder of Affect Mental Health, an incubator for mental health start-ups.
But Seegal said that 2019 will also raise some important questions related to privacy and consent, especially as consumers start to realize that the technology services they use on a regular basis are collecting knowledge about their health. “If Target knows that you’re pregnant, it sure as heck knows if you’re bipolar, as patterns of spending money is one of the things used in professional diagnosis.”
Opko Health: Phillip Frost settles civil stock-fraud charges with SEC
Phillip Frost, the billionaire Miami philanthropist and chair and CEO of pharma group OPKO Health, Inc., said Thursday he had reached an agreement with the Securities and Exchange Commission to settle a civil complaint of stock fraud.
“We have reached agreement with the SEC that will end a potentially expensive, contentious and time-consuming litigation and I am happy that we can focus on an exciting and productive 2019 for OPKO Health,” Frost said in a statement.
Frost, the namesake of Miami’s new science museum, and OPKO were charged in September with participating in a scheme that involved artificially inflating the price of penny stocks. This was allegedly done through maneuvers including paying bloggers to tout the companies without disclosing those payments.
Without admitting or denying the SEC’s allegations, Frost, 82, agreed to pay a $5.5 million penalty and a ban, with certain exceptions, on trading in penny stocks. OPKO agreed to pay a $100,000 penalty. The settlement must still be approved by a court. Frost’s Gamma Investments Trust, an investment vehicle controlled by Frost and named as a defendant in the SEC’s complaint, also settled, agreeing to a bar on trading in penny stocks.
Frost will continue to serve as OPKO’s CEO and Chairman. In September, Frost stepped down as chairman of financial group Ladenburg Thalmann, a position he had held for more than a decade. This week, Ladenburg purchased stock and options from Frost, the company’s largest shareholder, for $130.25 million. He now owns less than 5 percent of its outstanding shares.
Of the 10 individuals named in the SEC’s initial complaint, only Frost and John H. Ford, one of the alleged penny stock promoters, have settled. The other individuals, including Barry Honig, a South Florida-based investor whom the SEC named in its complaint as the pump-and-dump scheme’s “primary strategist,” have until Feb. 8, 2019, to enter a formal plea.
Roivant, Daiichi Sankyo in Broad Pipeline Partnership
Roivant Sciences announced that it has entered into a collaboration with Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) to facilitate the out-licensing of investigational medicines. Under the terms of the agreement, Roivant will have the option to obtain exclusive licenses for certain development programs from Daiichi Sankyo on prespecified terms contingent on phase of development (see also Roivant Sciences).
Daiichi Sankyo has a wide range of compounds in development. Medicines that Roivant opts to license will be developed by new subsidiary companies within the Roivant family.
“It has been an honor and a pleasure for us to work with the entire Daiichi Sankyo team in the course of creating this partnership. I hope this can be a model for platform collaborations between Roivant and other innovative biopharmaceutical companies in the future,” said Dr. Mayukh Sukhatme, President of Roivant Pharma. “We look forward to accelerating the development of promising medicines from the impressive R&D engine at Daiichi Sankyo in the months and years ahead.”
Sony increases production of 3D cameras amid rising demand
Sony (SNE) is boosting the output of its next-gen 3D sensors that power front- and rear-facing 3D cameras of smartphones and other devices, Bloomberg reports, citing the head of Sony’s sensor division. The report states that Sony’s customers include Apple (AAPL), though the company did not disclose the increased sales numbers or updated production targets.
Blue Light Floods NYC Sky as Transformer Explodes in Queens
A transformer explosion in Queens sent an eerie blue light flooding the nighttime sky over New York City Thursday night, startling residents.
Con Edison says a brief electrical fire caused a couple of transformers to offline at the substation at 20th Avenue and 32nd Street. Firefighters responded along with the utility crews.
The explosion lit the sky so brightly that it briefly appeared to be daytime in neighborhoods like Astoria and Woodside, residents reported. Smoke arose from the source of the blue light, visible from as far as Manhattan.
People in Queens reported the electricity briefly flickering off in their homes, and LaGuardia Airport saw a total blackout at one point. A News 4 staffer picking up his daughter in Terminal A said the lights started to flicker, then turned off completely while the emergency lighting stayed on.
The FAA has instituted a ground stop at LaGuardia until 10:30 a.m. Friday. The FAA won’t lift the ground stop until power is restored.
The NYPD is asking people to avoid the area of 20th Avenue and 31st Street in Astoria while they investigated.
Firefighters were initially called for a transformer fire there, radio transmissions on Broadcastify show.
“There’s a high-voltage emergency going on the ConEd plant, heading that way now,” one firefighter says. “Can we have a representative from Con Ed meet us out on 20th Avenue? It just seems like whatever it was just shut down. We’ll meet them at the main gate.”
“Yeah, whatever was arcing the skyline, it turned off, it seems like,” he continued. “Just advise Battalion 49, we have a visible fire in the ConEd plant. We’re going to enter off of 31st Street.”
FDNY radio transmissions revealed some of the respons
No one was injured. Mayor de Blasio tweeted that Con Edison was evaluating outages.
Zair Montes@zairmontes
Izzy Chester@IzzyChester1
Rich Villodas@richvillodasMassive blue light over Queens. Crazy!!! What in the world?!?!?!?! @NYCMayor
Jacob Trevino@JTrevinoNanoWhat is going on on out towards Queens? Strange very bright light show. #nyc
NYCFireWire@NYCFireWireExplosion at the ConEd plant in Astoria. TL-117 confirming a fire at the facility
George Martinez@gmartinez100
239 people are talking about this
NYCFireWire@NYCFireWireExplosion at the ConEd plant in Astoria. TL-117 confirming a fire at the facility
kjones4215@kjones4215
Bagagem@Bagagem72
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