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Friday, May 25, 2018

Google and Facebook accused of breaking GDPR laws


Complaints have been filed against Facebook, Google, Instagram and WhatsApp within hours of the new GDPR data protection law taking effect.
The companies are accused of forcing users to consent to targeted advertising to use the services.
Privacy group noyb.eu led by activist Max Schrems said people were not being given a “free choice”.
If the complaints are upheld, the websites may be forced to change how they operate, and they could be fined.

What’s the issue?

The General Data Protection Regulation (GDPR) is a new EU law that changes how personal data can be collected and used. Even companies based outside the EU must follow the new rules if offering their services in the EU.
In its four complaints, noyb.eu argues that the named companies are in breach of GDPR because they have adopted a “take it or leave it approach”.
The activist group says customers must agree to having their data collected, shared and used for targeted advertising, or delete their accounts.
This, the organisation suggests, falls foul of the new rules because forcing people to accept wide-ranging data collection in exchange for using a service is prohibited under GDPR.
“The GDPR explicitly allows any data processing that is strictly necessary for the service – but using the data additionally for advertisement or to sell it on needs the users’ free opt-in consent,” said noyb.eu in a statement.
“GDPR is very pragmatic on this point: whatever is really necessary for an app is legal without consent, the rest needs a free ‘yes’ or ‘no’ option.”
Privacy advocate Max Schrems said: “Many users do not know yet that this annoying way of pushing people to consent is actually forbidden under GDPR in most cases.”
Max SchremsImage copyrightREUTERS
Image captionLawyer Max Schrems is a privacy advocate
The complaints were filed by four EU citizens with local regulators in Austria, Belgium, France and Germany.
Analysts and regulators had expected complaints to be filed shortly after the introduction of the law, as organisations and privacy advocates argue over how the law should be interpreted.

‘Huge fines’

Some companies based outside the EU have temporarily blocked their services across Europe to avoid falling foul of the new legislation.
However, others such as Twitter have introduced granular controls that let people opt out of targeted advertising.
Companies that fall foul of GDPR can be – in extreme cases – fined more than £17m.
Facebook said in a statement that it had spent 18 months preparing to make sure it met the requirements of GDPR.
Google told the BBC: “We build privacy and security into our products from the very earliest stages and are committed to complying with the EU General Data Protection Regulation.”

FBI says foreign hackers have compromised home router devices


The FBI warned on Friday that foreign cyber criminals had compromised “hundreds of thousands” of home and small office router devices around the world which direct traffic on the internet by forwarding data packets between computer networks.
In a public service announcement, the FBI it has discovered that the foreign cyber criminals used a VPNFilter malware that can collect peoples’ information, exploit their devices and also block network traffic.
The announcement did not provide any details about where the criminals might be based, or what their motivations could be.
“The size and scope of the infrastructure by VPNFilter malware is significant,” the FBI said, adding that it is capable of rendering peoples’ routers “inoperable.”
It said the malware is hard to detect, due to encryption and other tactics.
The FBI urged people to reboot their devices to temporarily disrupt the malware and help identify infected devices.
People should also consider disabling remote management settings, changing passwords to replace them with more secure ones and upgrading to the latest firmware.

Non-Industrial Robots Seen at Over 75% of Total Revenue by the End of 2018


The robotics market continues to experience a profound and significant restructuring as the traditional industrial robotics sector continues to shrink as an overall percentage of the total robotics market. According to a new report from Tractica, non-industrial robots represented 70% of the $39.3 billion robotics market globally in 2017, growing from a 64% share in 2016. By the end of 2018, the market intelligence firm expects that non-industrial robots will rise to 76% of the total market, which will have grown to $52.7 billion by that time.
Tractica’s analysis finds that most robotics industry growth is being driven by segments like consumer, enterprise, healthcare, military, unmanned aerial vehicles (UAVs), and autonomous vehicles.
According to research director Aditya Kaul, “Consequences of this shift are already beginning to play out, evidenced by recent acquisitions of industrial robotics companies by players in other sectors including consumer electronics companies.”
Moreover, Kaul adds that the epicenter of robotics continues to shift from the traditional centers of Japan and Europe toward the emerging artificial intelligence (AI) hotbeds of Silicon Valley and China. Says Kaul, “AI technologies like deep learning, computer vision, and natural language processing (NLP) are revolutionizing autonomy and UI/UX capabilities in robots.”
Tractica’s report, “Robotics Market Forecasts”, covers the global market for robotics, including consumer robots, enterprise robots, industrial robots, healthcare robots, military robots, UAVs, and autonomous vehicles. These categories are further segmented into 23 robot application markets. Market data within the report includes robot shipments and revenue segmented by world region, application market, and enabling technology. The technologies included in the attach rate analysis are machine vision, voice/speech recognition, gesture recognition, and tactile sensors. The forecast period for this report extends from 2017 through 2025. An Executive Summary of the report is available for free download on the firm’s website.

LabCorp to Become a Preferred National Laboratory for Aetna

 Aetna(NYSE: AET) and LabCorp® (NYSE: LH) today extended and expanded their existing agreement, making LabCorp a preferred national laboratory for substantially all of Aetna’s members beginning January 1, 2019. The expanded agreement will provide more than 20 million eligible members with in-network access to LabCorp’s full range of laboratory services. LabCorp is already an in-network laboratory for several million members of Aetna and Aetna-affiliated health plans in certain markets across the U.S.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180525005107/en/
“This expanded agreement is the culmination of our years-long effort to return to a full collaborative relationship with Aetna,” said David P. King, chairman and chief executive officer of LabCorp. “We and Aetna share a commitment to making high-quality, high-value laboratory testing more accessible, improving the way care is delivered and enhancing the customer experience in all aspects of laboratory services. We are excited about the opportunity this agreement presents and look forward to working more broadly with Aetna and its members to enable better health outcomes.”
“Consumers are looking for greater convenience and affordability for their health care services,” said Paul McBride, head of National Provider Networks, Strategy and Experience at Aetna. “We are pleased to offer Aetna members greater access to LabCorp’s core and specialty lab services at reasonable costs through its nearly 2,000 patient service centers.”
Aetna plan participants will benefit from LabCorp’s scientific expertise, advanced technology and integrated data to help improve the delivery of care. LabCorp offers nearly 5,000 frequently requested and specialty tests, including a wide range of clinical, anatomic pathology, genetic, and genomic tests, delivered through LabCorp’s broad patient access points, including a growing retail presence. LabCorp also offers an industry-leading suite of patient-facing tools, including its new mobile app that allows customers to make appointments, receive results and pay invoices from their handheld devices. In addition, LabCorp offers physicians and patients the opportunity to participate in clinical studies through its Covance Drug Development business, helping to identify and bring new treatments to market.

Alexion Offer for Wilson Therapeutics Accepted


Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that its offer, through a wholly owned subsidiary, for the shares in Wilson Therapeutics has been accepted by shareholders representing 97.7 percent of the total number of shares and votes in Wilson Therapeutics. The acquisition has also been approved by relevant regulatory authorities. As more than 90 percent of the total number of shares have been tendered and all conditions of the offer have been fulfilled, the offer has been declared unconditional and settlement of the tendered shares will occur on May 30, 2018.
“The acquisition of Wilson Therapeutics is a key first step in rebuilding our pipeline,” said Ludwig Hantson, Ph.D., Chief Executive Officer of Alexion. “We look forward to using our significant experience in rare metabolic and neurological diseases to improve treatment for patients with Wilson disease through the development of WTX101, which has the potential to be the first new treatment in more than 20 years and become the new standard of care for Wilson disease.”
In order to give Wilson Therapeutics’ shareholders additional time to accept the offer, Alexion has extended the acceptance period until June 8, 2018. Settlement for shares tendered during this extended acceptance period is expected on June 15, 2018.
Alexion intends to initiate compulsory redemption proceedings regarding the remaining shares in Wilson Therapeutics as well as to promote a delisting of the shares from Nasdaq Stockholm.
For additional details on the transaction, please visit http://ir.alexion.com/acquisitions.cfm.
About Wilson Disease
Wilson disease is a rare, chronic, genetic, and potentially life-threatening liver disorder of impaired copper transport. Copper balance is normally maintained in the body by hepatic excretion of excessive copper in the bile. In patients with Wilson disease, a genetic mutation disables this biliary excretion pathway and excess copper accumulates over time in the liver cells. The accumulation of copper eventually overwhelms safe storage capacity and cellular injury occurs. When the liver’s capacity for copper storage is exceeded, and when liver cells are injured, copper is released into the circulation and may accumulate in other organs, including the central nervous system. Untreated, Wilson disease leads to various combinations and severity of hepatic, neurologic, and psychiatric symptoms, and can be fatal.1,2
Wilson disease affects approximately one in every 30,000 people worldwide.3 The average age of diagnosis is 15-20 years,3 with the majority of patients presenting between the ages of 10 and 30.4 Current standard of care includes metal chelators to remove serum copper, followed by maintenance with zinc to prevent re-accumulation.1,2 There have been no new treatment options approved in over two decades and a significant unmet need still exists for patients.
About WTX101
WTX101 (bis-choline tetrathiomolybdate) is a first-in-class copper-binding agent with a unique mechanism of action, under investigation as a novel therapy for Wilson disease. In contrast to current treatments, WTX101 provides an alternative copper-protein binding mechanism by forming a tripartite complex with copper and albumin. WTX101 thereby detoxifies excess copper in both liver and blood, and promotes copper clearance through biliary excretion (the body’s natural route of elimination). WTX101 has a 10,000-fold higher affinity for copper than other chelators and addresses the underlying cause of the disease.
A Phase 2 study evaluating the efficacy and safety of WTX101 in patients with Wilson disease has been completed successfully.5 In addition, the active moiety of WTX101, tetrathiomolybdate, has been tested in several previous clinical studies in Wilson disease patients. The data from these studies suggest that WTX101 can reduce and control free copper levels and improve symptoms and associated disabilities. The data also suggest that WTX101 is generally well tolerated with a low risk of drug-induced neurological worsening. WTX101 has received Fast Track designation in the U.S. and Orphan Drug Designation for the treatment of Wilson disease in the U.S. and EU.

Magenta Therapeutics Eyes $100M IPO To Speed Bone Marrow Transplant Programs


Weeks after securing $52 million in a Series C financing, Magenta Therapeutics is eying the raising of $100 million in an initial public offering two years after it was launched by Third Rock Ventures and Atlas Venture with $48.5 million in Series A financing.
Cambridge, Mass.-based Magenta said it intends to use the funds from the IPO to advance its portfolio of bone marrow transplant medications. Bone marrow transplant is often used to treat certain types of blood cancers and genetic diseases. Magenta’s approach to address some of the issues with traditional marrow transplants is to use antibodies that recognize stem cells linked to drugs that can then selectively remove stem cells and diseased cells. The approach by Magenta is believed to have fewer side effects and toxicity.
In its S-1 filing with the U.S. Securities and Exchange Commission, the company said it intends to use the funding to specifically advance the development of two clinical assets, MGTA-456 and MGTA-145. With the finances gained from going public, Magenta said it would be able to support the development programs with investments in manufacturing and potential commercialization. Magenta said it will also use some of the money to initiate asset studies in other indications, such as sickle cell disease and blood cancers.
The Phase II MGTA-456 is the company’s most advanced asset. Magenta in-licensed MGTA-456 last year from Novartis. MGTA- 456 is a first-in-class allogeneic stem cell therapy consisting of a single umbilical cord blood unit expanded with an aryl hydrocarbon receptor (AHR) antagonist. Magenta believes MGTA-456 has the potential to treat patients with higher cell doses than otherwise possible and to have access to better HLA-matched cord blood units. In April the company dosed the first patient in the Phase II MGTA-456 trial. The patient has an undisclosed inherited metabolic disorder, the company said at the time.
Magenta’s MGTA-145 is being developed in order to help physicians have an easier time in harvesting a greater number of blood stem cells, which are known as hematopoietic stem cells or HSCs, from patients and donors to improve patient outcomes.
While Magenta said in its filing that it’s primarily focused on advancing its internal assets, the company noted that it could use some of the proceeds from the IPO to “in-license, acquire or invest in new businesses, technology or assets.” Magenta said it has no deals on the table but does “evaluate such opportunities” periodically.
Funds from an IPO will also likely be used to advance assets in its developmental deal with Germany’s Heidelberg Pharma GmbH. In March the two companies forged a multi-target research deal to improve curative bone marrow transplantation. Under terms of that deal, the companies will use Magenta’s stem cell platform and proprietary antibodies with Heidelberg’s proprietary ATAC (Antibody Targeted Amanitin Conjugates) platform to focus on up to four targets.
As Magenta looks to the IPO, the company closed out the first quarter with $41.5 million. The April financing round of $52.3 million gives the company just under $95 million in available cash.

AstraZeneca Med Shows Positive Overall Survival Results in Lung Cancer Trial


AstraZeneca and its research-and-development unit MedImmune, announced positive overall survival (OS) data for its Phase III PACIFIC trial of Imfinzi (durvalumab) in patients with unresectable Stage III non-small cell lung cancer (NSCLC).
The patient population has NSCLC whose disease had not progressed after platinum-based chemotherapy and radiation therapy. An interim analysis by an Independent Data Monitoring Committee decided the trial had met its second of two primary endpoints—statistically-significant OS benefit with clinically-meaningful improvement in patients on Imfinzi compared to placebo.
“The readout of positive overall survival data at the interim analysis of the PACIFIC trial provides additional compelling evidence of the clinical benefit that Imfinzi can offer patients in this earlier stage of lung cancer,” said Sean Bohen, AstraZeneca’s executive vice president, Global Medicines Development, and chief medical officer, in a statement. “We look forward to sharing these results with Health Authorities to support ongoing regulatory interactions and to update the Imfinzi label with these important data.”
Imfinzi is a human monoclonal antibody that binds to PD-L1, blocking the interaction of PD-L1 with PD-1 and CD80. The drug received approval in Canada earlier this month for patients with unresectable Stage III NSCLC after chemoradiation therapy (CRT). In February, the U.S. Food and Drug Administration (FDA) granted the drug approval for patients with unresectable Stage III NSCLC who had not progressed after concurrent platinum-based CRT.
The drug is being tested as a monotherapy and in combination with chemotherapy radiation therapy, small molecules, and an anti-CTLA4 monoclonal antibody called tremelimumab as a possible first-line treatment for NSCLC, small cell lung cancer, locally-advanced or metastatic urothelial cancer, head and neck cancer and other solid tumors.
The results here will help AstraZeneca stay in the competition with Merck and Bristol-Myers Squibb, both battling to offer the drug-of-choice for front-line lung cancer. Only a couple days ago, Dave Fredrickson, head of AstraZeneca’s oncology business unit, told investors, “This has resulted in a true inflection point for Imfinzi with sales now at $62 million in the first quarter and really the overwhelming majority of these coming from the lung cancer indication. As you saw from a slide that Pascal [Soriot, company chief executive officer] showed in February when we launched, we had about 3,500 patient infusions per month and you could see that we’ve now doubled in the most recent month to 7,000 patient infusions per month, really showing that the underlying patient demand is the driver of these sales.”
The data presented late last year indicated that patients receiving Imfinzi lived 16.8 months longer on average without their disease getting worse, compared to 5.6 months for patients on placebo. That led to FDA approval in February for NSCLC patients with inoperable mid-stage disease that had not metastasized. It was the first immunotherapy to be approved in that setting.
CNBC reports, “That distinguishes it from rivals Merck, Bristol-Myers Squibb and Roche that beat the British drugmaker in winning approval for similar immunotherapies in advanced or metastatic disease. Analysts believe using Imfinzi in stage III lung cancer, where cancer has only spread locally, opens up a multibillion-dollar sales opportunity and the latest overall survival (OS) data should underline the drug’s potential.”
Analysts with Berenberg wrote in a note to investors, “Consensus has peak Imfinzi sales at $2.8 billion by 2023 and the achievement of an OS benefit may not result in much of a change in sales expectations. Nevertheless … the OS data will help Astra in its physician education and ensure the peak sales can be achieved.”
The company indicated it will publish full details at an upcoming medical conference.