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Wednesday, May 16, 2018

Amgen receives EC approval for Repatha to prevent heart attack, stroke

Amgen announced that the European Commission has approved a new indication in the Repatha label for adults with established atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering low-density lipoprotein cholesterol levels. With the expanded label now in place, Amgen is working with payers in Europe to remove prescribing barriers and expand access in order to reach patients with established cardiovascular disease who are at risk of another event.

Weight Watchers CEO on Relevance in Era Of Apps And Wearables

Weight Watchers International, Inc. WTW was founded decades before fitness apps and wearables, which gave the company by default an advantage over new-age technologies that promote losing weight. But how can the company continue to remain relevant against companies like Fitbit Inc FIT whose fitness tracking products makes it easier for people to get in better shape?
There’s plenty of room to co-exist, Weight Watchers CEO Mindy Grossman told CNBC Tuesday morning. Specifically, Weight Watchers boasts 1.3 million unique users who sync the Weight Watchers app with their fitness device. This creates a scenario where Weight Watchers offers a “complete holistic concept of wellness” for people.

‘Everyday App’

Weight Watchers’ biggest competition isn’t a tech giant or hardware maker, Grossman said. The biggest competition is from people who think they can get healthy themselves as only 5 percent of people looking to become healthy use some sort of commercial weight loss program.
“We are focused on being the partner for the 95 percent to really help them to be empowered to get healthy,” Grossman said. “And that’s what people want today. They don’t want to be dictated to — they want to define what healthy means to them.”
With that said, Weight Watchers wants to position itself as being an “everyday app” for people looking to lose weight, which implies it has minimal desire to enter the hardware space directly with a fitness tracking device, Grossman said. In other words, why fix what isn’t broken? Weight Watchers’ digital community called Connect ended the first quarter with a record 4.6 million users and the highest retention rate in the platform’s history.

Millennials

The millennial demographic group is at the forefront of wanting to “describe what is healthy” and “what beauty means to them,” Grossman said. At the same time, millennials also want community engagement and connect with others.
The Weight Watchers platform also appeals to millennials since it never dictates what people need to eat and need to avoid eating, she said. The program “fits in to their life, not the other day around.”

FibroGen Upgraded By Mizuho On Continued R&D Progress

A combination of slightly better-than-expected first-quarter earnings and potential regulatory approval on the horizon have solidified one analysts faith in FibroGen Inc FGEN moving towards the end of the year.

The Analyst

Mizuho’s Difei Yang upgraded shares of FibroGen from Neutral to Buy with a $61 price target.

The Thesis

The company recently reported Q1 earnings. Earnings came in at a loss of 50 cents per share, roughly in line with the consensus estimate, while sales of $31.925 million beat the $27.15 million estimate.
More notably, FibroGen has continued to make progress on its research and development pipelines. In particular, the company’s Roxadustat stood out the Yang. Top-line Phase III data is expected in Q4 this year, and the drug has received priority review from the China FDA, with potential approval arriving by the year’s end.
“We believe the company is likely to gain the first approval in new generation anemia drugs,” Yang said in a note.
The analyst is also looking forward to an update on Pamrevlumab by mid-year 2018, and expects significant upside if it can reproduce its Phase II results in the planned Phase III trial.

Gottlieb: FDA to start plans to increase competition in drug markets this week

The Food and Drug Administration will launch one of its first programs following the release of the Trump administration’s new drug price plan this week.
The agency will launch on Thursday a website that offers more details on the branded drugs generic drugmakers have trouble getting their hands on, said FDA Commissioner Scott Gottlieb, M.D. The website will retroactively include information on about 150 inquiries made about 50 brand-name medications and will be updated on ongoing basis in the future, he said.
Some drugs had several inquiries from generic drug manufacturers, while others may only have had one, he said.
The FDA head gave a look into the agency’s plans as part of the Trump administration’s overall strategy to lower drug prices at a briefing with reporters on Tuesday morning.
“Branded companies are on notice,” Gottlieb said.
It will also indicate which drugs require a Risk Evaluation and Mitigation Strategy (REMS) and which could make it harder for generic drug companies to acquire samples for development. The FDA will note if it sent an official letter to the brand-name drug company in the case, Gottlieb said.
Generic drug companies have long complained of impeded generic drug development by brand-name drug manufacturers who hinder access to samples. Increasing competition in the markets by encouraging generic drug and biosimilar development is a key element of the White House’s plan to lower drug prices, which was unveiled last Friday.
In addition to the website’s launch this week, FDA is planning to release guidance at the end of the month that would allow generic drug companies to apply for waivers to create their own REMS if they can show that the negotiations to acquire samples are dragging on, Gottlieb said.
Just taking steps to suggest that these waivers could be offered would likely be a deterrent to the abuse the Trump administration decried in its pricing plan, he said.
Gottlieb also noted the role that pharmacy benefit managers can play in preventing generic drugmakers from accessing samples. Brand-name drug companies will bring contract provisions to them, he said, but the FDA hasn’t seen any PBMs “say they’ll stop” withholding the samples thus far.
In addition, the FDA will unveil an overhaul to its approval process in early June, Gottlieb said, which should help bring more drugs to market and increase competition.
Scott Gottlieb, M.D.
✔@SGottliebFDA
 will unveil in June a major updating of the structure and function of its new drug review process to make it more modern, rigorous, to better integrate cross disciplinary science as part of collaborative teams, develop more focused review divisions https://www.biocentury.com/biocentury/politics-policy-law/2018-05-11/fda-reorganizing-office-new-drugs-stay-ahead-drug- 
FDA is reorganizing the Office of New Drugs to stay...

FDA is reorganizing the Office of New Drugs to stay…

FDA is reorganizing the Office of New Drugs in its Center for Drug Evaluation and Research, seeking to make review…
biocentury.com
Another step the FDA is taking, Gottlieb said, is examining how it could push drug companies to boost transparency by including drug prices in advertising. He said he doesn’t “want to get to too far ahead of the process,” but that there are legal hurdles to be addressed before a program could truly be launched, as there’s a risk that requiring price transparency would be unconstitutional “compelled speech.”
The FDA has convened a working group to dive further into this issue, he said. One of the key issues that group will have to iron out if they can push pharma companies to include prices in ads is determining which price is most effective. Most patients don’t pay the list price, for example, he said, so there may be “better proxies” to use.
Gottlieb also sounded off on elements of the plan that touch on coverage for drugs and proposed changes to Medicare that the administration is backing. The administration’s plan calls for payers and PBMs to move from the current rebate-centric model to a straight discount model for drug pricing, so that patients more directly see the savings. That’s a change that Medicare can drive, Gottlieb said.
Medicare’s drug coverage needs to catch up to the current times, he said. The administration is taking another look at Part B because “we’re in a much different situation today” than when the program was established.
Drugs in certain Part B categories—such as cancer medications—aren’t as novel as they were at one time, so re-evaluating payment to keep up with the proliferation of these medications is key, he said.
“I don’t think anyone anticipated how competitive these categories would become,” Gottlieb said.

Novartis top lawyer exits in wake of Trump attorney deal

Novartis (NOVN.S) General Counsel Felix Ehrat will leave the Swiss drugmaker over his role in a $1.2 million contract it struck with the personal lawyer for U.S. President Donald Trump, saying on Wednesday the pact was legal but an error.
The $100,000-per-month contract with Trump attorney Michael Cohen’s Essential Consultants, the same firm used to pay porn star Stormy Daniels $130,000 to hush up an alleged affair with Trump, has distracted Novartis’s efforts to improve its image after a series of bribery scandals.
Trump has denied the affair. Novartis ended the contract this year.
The contract was approved in early 2017 under the former Novartis chief executive Joe Jimenez and was part of its efforts to learn more about how the new Trump administration might approach certain U.S. healthcare policy matters.
U.S. lawmakers have demanded Novartis as well as AT&T (T.N), which also made payments to Cohen’s firm, provide details about their contracts. Ron Wyden, the top Democrat on the Senate Finance Committee, has called the transactions part of a “pay-to-play scheme” and initiated an investigation.
In a company statement ahead of an investor day on Wednesday, Ehrat acknowledged that he signed the contract along with Joe Jimenez, who stepped down on Feb. 1 and was replaced by Vas Narasimhan.
“Although the contract was legally in order, it was an error,” Ehrat said. “As a co-signatory with our former CEO, I take personal responsibility to bring the public debate on this matter to an end.”
Novartis has sought to distance Narasimhan from the contract, saying he had nothing to do with it. It said on Wednesday that the board was not aware of the contract with Cohen.
“We also have made mistakes recently and the world rightly expects more from a leading healthcare company,” Narasimhan said. “Our new executive team and I have a deep commitment to ensure we always operate with the highest integrity and sound judgment and will work hard to rebuild lasting trust with society.”
Since 2015, Novartis has paid out hundreds of millions in settlements and fines as a result of kickback allegations in South Korea, the United States and China and faces an investigation of alleged bribery in Greece. A trial for another bribery case has been scheduled for 2019 in the United States.
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Novartis shareholders have urged Narasimhan and other executives to exert more “moral influence” over perceived ethical shortcomings that Jimenez in 2016 blamed on a “results-oriented” sales culture and some bad actors. [reut.rs/2Ipdn83]
Ehrat will be replaced by Shannon Klinger, who is currently chief ethics officer. Narasimhan elevated Klinger to the executive committee this year as he made cultural change a priority.
At the meeting with investors, Narasimhan highlighted an extensive pipeline of new medicines that it believes have $1-billion-plus annual sales potential, placing it on track to grow sales and expand profit margins through 2022.
At the same time, the company will consider pruning non-core operations, including its U.S. generic pills business, while weighing further bolt-on acquisitions to strengthen its drug portfolio in key areas.
Priority areas for additional deals include cancer medicine, cell and gene therapies, and digital and data science.
Last month Narasimhan placed a big bet on gene therapy with an $8.7 billion deal to acquire AveXis (AVXS.O).

Tuesday, May 15, 2018

Lie-detecting computer kiosks with AI look like the future of border security

  • A virtual border agent kiosk was developed to interview travelers at airports and border crossings and it can detect deception to flag human security agents.
  • The U.S., Canada and European Union have tested the technology, and one researcher says it has a deception detection success rate of up to 80 percent — better than human agents.
  • The technology relies on sensors and biometrics, and its lie-detection capabilities are based on eye movements or changes in voice, posture and facial gestures.
Aaron Elkins, a professor at the San Diego State University, is working on a kiosk system that can ask travelers questions at an airport or border crossings and capture behaviors to detect if someone is lying.
Source: San Diego State University
Aaron Elkins, a professor at the San Diego State University, is working on a kiosk system that can ask travelers questions at an airport or border crossings and capture behaviors to detect if someone is lying.
International travelers could find themselves in the near future talking to a lie-detecting kiosk when they’re going through customs at an airport or border crossing.
The same technology could be used to provide initial screening of refugees and asylum seekers at busy border crossings.
The U.S. Department of Homeland Security funded research of the virtual border agent technology known as the Automated Virtual Agent for Truth Assessments in Real-Time, or AVATAR, about six years ago and allowed it to be tested it at the U.S.-Mexico border on travelers who volunteered to participate. Since then, Canada and the European Uniontested the robot-like kiosk that uses a virtual agent to ask travelers a series of questions.
Last month, a caravan of migrants from Central America made it to the U.S.-Mexico border, where they sought asylum but were delayed several days because the port of entry near San Diego had reached full capacity. It’s possible that a system such as AVATAR could provide initial screening of asylum seekers and others to help U.S. agents at busy border crossings such as San Diego’s San Ysidro.
“The technology has much broader applications potentially,” despite most of the funding for the original work coming primarily from the Defense or Homeland Security departments a decade ago, according to Aaron Elkins, one of the developers of the system and an assistant professor at the San Diego State University director of its Artificial Intelligence Lab. He added that AVATAR is not a commercial product yet but could be also used in human resources for screening.
The U.S.-Mexico border trials with the advanced kiosk took place in Nogales, Arizona, and focused on low-risk travelers. The research team behind the system issued a report after the 2011-12 trials that stated the AVATAR technology had potential uses for processing applications for citizenship, asylum and refugee status and to reduce backlogs.

High levels of accuracy

President Donald Trump‘s fiscal 2019 budget request for Homeland Security includes $223 million for “high-priority infrastructure, border security technology improvements,” as well as another $210.5 million for hiring new border agents. Last year, federal workers interviewed or screened more than 46,000 refugee applicants and processed nearly 80,000 “credible fear cases.”
The AVATAR combines artificial intelligence with various sensors and biometrics that seeks to flag individuals who are untruthful or a potential risk based on eye movements or changes in voice, posture and facial gestures.
“We’re always consistently above human accuracy,” said Elkins, who worked on the technology with a team of researchers that included the University of Arizona.
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According to Elkins, the AVATAR as a deception-detection judge has a success rate of 60 to 75 percent and sometimes up to 80 percent.
“Generally, the accuracy of humans as judges is about 54 to 60 percent at the most,” he said. “And that’s at our best days. We’re not consistent.”

The human element

Regardless, Homeland Security appears to be sticking with human agents for the moment and not embracing virtual technology that the EU and Canadian border agencies are still researching. Another advanced border technology, known as iBorderCtrl, is a EU-funded project that aims to increase speed but also reduce “the workload and subjective errors caused by human agents.”
A Homeland Security official, who declined to be named, told CNBC the concept for the AVATAR system “was envisioned by researchers to assist human screeners by flagging people exhibiting suspicious or anomalous behavior.”
“As the research effort matured, the system was evaluated and tested by the DHS Science and Technology Directorate and DHS operational components in 2012,” the official added. “Although the concept was appealing at the time, the research did not mature enough for further consideration or further development.”
Another DHS official familiar with the technology didn’t work at a high enough rate of speed to be practical. “We have to screen people within seconds, and we can’t take minutes to do it,” said the official.
Elkins, meanwhile, said the funding for the AVATAR system hasn’t come from Homeland Security in recent years “because they sort of felt that this is in a different category now and needs to transition.”
The technology, which relies on advanced statistics and machine learning, was tested a year and a half ago with the Canadian Border Services Agency, or CBSA, to help agents determine whether a traveler has ulterior motives entering the country and should be questioned further or denied entry.
A report from the CBSA on the AVATAR technology is said to be imminent, but it’s unclear whether the agency will proceed the technology beyond the testing phase.
“The CBSA has been following developments in AVATAR technology since 2011 and is continuing to monitor developments in this field,” said Barre Campbell, a senior spokesman for the Canadian agency. He said the work carried out in March 2016 was “an internal-only experiment of AVATAR” and that “analysis for this technology is ongoing.”
Prior to that, the EU border agency known as Frontex helped coordinate and sponsor a field test of the AVATAR system in 2014 at the international arrivals section of an airport in Bucharest, Romania.

People and machines working together

Once the system detects deception, it alerts the human agents to do follow-up interviews.
AVATAR doesn’t use your standard polygraph instrument. Instead, people face a kiosk screen and talk to a virtual agent or kiosk fitted with various sensors and biometrics that seeks to flag individuals who are untruthful or signal a potential risk based on eye movements or changes in voice, posture and facial gestures.
“Artificial intelligence has allowed us to use sensors that are noncontact that we can then process the signal in really advanced ways,” Elkins said. “We’re able to teach computers to learn from some data and actually act intelligently. The science is very mature over the last five or six years.”
But the researcher insists the AVATAR technology wasn’t developed as a replacement for people.
“We wanted to let people focus on what they do best,” he said. “Let the systems do what they do best and kind of try to merge them into the process.”
Still, future advancement in artificial intelligence systems may allow the technology to someday supplant various human jobs because the robot-like machines may be seen as more productive and cost effective particularly in screening people.
Elkins believes the AVATAR could potentially get used one day at security checkpoints at airports “to make the screening process faster but also to improve the accuracy.”
“It’s just a matter of finding the right implementation of where it will be and how it will be used,” he said. “There’s also a process that would need to occur because you can’t just drop the AVATAR into an airport as it exists now because all that would be using an extra step.”

WATCH: Researchers say they’ve created an automated test that can tell if you’re lying by tracking your eyes

Researchers say they’ve created a test that can tell if you’re lying by tracking your eyes

California assisted death law overturned in court

A judge in Riverside County on Tuesday overturned California’s controversial assisted death law nearly two years after it took effect, ruling that the Legislature improperly passed the measure during a special session on health care funding.
The court is holding its judgment for five days, according to representatives for supporters and opponents of the law, to give the state time to file an emergency appeal.
“We’re very satisfied with the court’s decision today,” said Stephen G. Larson, lead counsel for a group of doctors who sued in 2016 to stop the law. “The act itself was rushed through the special session of the Legislature and it does not have any of the safeguards one would expect to see in a law like this.”
The state plans to seek expedited review in an appellate court, according to Attorney General Xavier Becerra, who said in a statement that he strongly disagreed with the ruling.
Assemblywoman Susan Talamantes Eggman, the Stockton Democrat who carried the bill, said Californians who are in the process of obtaining life-ending drugs through the law have had “the carpet ripped out from under their feet.”
“It’s a reminder for all of us that there are those out there who would like to take our rights away,” she said. “When we move forward, there are those who would like to drag us back.”
Signed by Gov. Jerry Brown in 2015, the assisted death law allows doctors to prescribe lethal drugs to patients with six months or less to live. Hundreds of Californians have already taken advantage of that option, including 111 individuals who died from taking the drugs in the first seven months of their availability.
Proponents say it provides dignity to terminally ill patients by affording them more control over the end of their lives.
But the legislative push originally fell short amid opposition from oncologists, Catholic hospitals, clergy and disability rights groups, who argued that the policy was immoral and could have a detrimental impact on health care for the state’s most vulnerable patients.
After failing in regular session, lawmakers successfully revived the assisted death proposal in a special session called that summer by Brown to find a source of funding for public health programs.
Larson said his clients are most concerned about a lack of protections in the law, including an inadequate definition of terminal illness and a provision exempting doctors who prescribe the lethal drugs from liability. But he said they also challenged the manner in which the law was passed, an argument the judge sided with on Tuesday.
“That special session was called to address funding shortages caused by Medi-Cal,” Larson said. “It was not called to address the issue of assisted suicide.”
Supporters noted that the ruling was not about the legality of assisted death and that public polls have indicated the law has widespread approval in California. Advocacy group Death With Dignity National Center sent out a fundraising email Tuesday afternoon decrying “shadowy, religious-right groups attempting to derail the law any way they can” for “disrespecting the will of the people.”
Eggman said Brown would have known “what he intended with the breadth of the special session,” which also included objectives to “improve the efficiency and the efficacy of the health care system,” and he signed the law.
Compassion & Choices, the organization that led the effort to legalize assisted death in California, also objected to the judge’s interpretation.
“He’s not acknowledging it’s a health care issue, even though we believe it is,” spokesman Sean Crowley said. “It deals with medication.”