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The Iceman, Kimi Räikkönen Reveals the Secret of Staying the Coolest F1 Driver

F1 driver Kimi Räikkönen, also known as the ”Iceman” has started co-operation with the CTN Group. CTN is a company specialising in recovery equipment using super cold temperatures, also called Cryotherapy. The technology is developed and manufactured in Finland by the local group subsidiary, and their cutting edge equipment offers help in recovery, stress reduction, improved quality of sleep and pain relief. The CTN Group is a global pioneer in high-end cold therapy equipment, with products exported to more than 35 countries. Latest patented innovations enable localised cold therapy treatments without liquefied gasses, using only standard electricity. The company launched earlier this year the first electric-only X°Cryo device, which makes cryotherapy more affordable and accessible to a much wider clientele than before. This treatment traditionally used mainly by top athletes has now become a feasible option for all of us.

“Many international sports and entertainment mega-stars have already discovered the benefits of cold therapy, but with the Iceman, Kimi Räikkönen, we found a perfect match and great global ambassador for our brand. Despite the well funded large and professional teams behind them, Formula 1 is a very demanding sport for the driver. It requires both physical and mental strength and undivided and continuous focus. As soon as we heard that Kimi had found the benefits of cold therapy, it was a very natural and mutually beneficial decision to start working together with him and to provide him the best available equipment to optimise his performance”, says Mr. Mare Oravainen, Chief Sales officer of the CTN Group.

Kimi Räikkönen’s Swiss home is now equipped with both a whole body cryotherapy cabin (CTN Cryo°Cabin) using liquid nitrogen and the electrically powered X°Cryo for localised treatments. Thanks to this co-operation he will become one of CTN Group’s most renowned international top athlete references.

“Driving a F1 car requires top-level fitness both mentally and physically. In particular, the legs and lower back are under heavy strain, and I’ve noticed that using the cryotherapy regularly accelerates my recovery and reliefs instantly pains and aches caused by physical training or a tough race weekend. It also relaxes the mind in a similar way as the ice baths I used to take, but this is a more effective and much faster way to recover and it really relaxes both the mind and body. I have always relied and liked Finnish high-tech and know-how, and when I learned that this equipment is being manufactured in Finland, to choose the right equipment for me was easy. When I am at home, I use the cold therapy equipment every day, and whenever possible I use the localised X°Cryo during the race weekends as well,” says Kimi Räikkönen.

CTN Group is the global technology leader in its field and has delivered cutting edge cryotherapy equipment to wide variety of professional athletes and teams, including NHL, NFL, ATP tennis stars etc. The company’s latest innovation is the electrically powered X°Cryo local treatment device, which is expected to revolutionise the availability of Cryotherapy as an easy-to-use, affordable, safe and more mobile option.

“The popularity of drug free therapies is growing, and I believe that not only top athletes, but also ordinary consumers will soon find the benefits of cryotherapy treatments. With the new electric X°Cryo, and its patented Cryomask option you can also refresh your face, reduce liquid retention, accelerate blood circulation to your entire head. The derma applicators enable efficient treatment of wide variety of skin symptoms and the physio treatment heads provide targeted relief for a variety of muscle and joint inflammation and pains”, says CTN Group’s medical director doctor Timo Kylmälä, MD. Phd.

Source: TokenMarket News
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ICO Decision On Ministry Of Education HQ

Information Commissioner Gitanjali Gutierrez issued Decision 26/2019, which concerns the search conducted by the Ministry of Education Headquarters in its original handling of a request under the PATI Act.

A spokesperson said, “On 8 November 2019, Information Commissioner Gitanjali Gutierrez issued Decision 26/2019 Ministry of Education Headquarters. This Decision concerns the reasonableness of the search conducted by the Ministry of Education Headquarters [Ministry] in its original handling of a request under the Public Access to Information [PATI] Act 2010.

“In Decision 26/2019, the requester sought records related to the Ministry’s Adopt-a-School programme. The requester sought an Information Commissioner’s review of the Ministry’s decision, which disclosed some records but stated that no other records related to the programme were held. During the Information Commissioner’s review, the Ministry agreed to conduct additional searches and was able to locate additional responsive records.

“The Information Commissioner held that the Ministry did not conduct a reasonable search in its original handling of the PATI request, but was satisfied that the additional searches conducted during the review was reasonable.

“The Information Commissioner has required the Ministry to process the records responsive to the PATI request and issue a new initial decision denying or granting access to the records in accordance with the PATI Act within six weeks.”

A full version of Decision 26/2019 follows below [PDF here]:

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ICO calls for live facial recognition code of practice to stop police turning the UK into Xinjiang

ICO calls for live facial recognition code of practice to stop police turning the UK into Xinjiang

Met Police foiled in bid to turn London into Xinjiang

The Information Commissioner has called for a new code of practice to control police use of live facial recognition. 

It follows an investigation into trials conducted by South Wales Police and the Metropolitan Police that, the ICO claims, “raises serious concerns”.

Information Commissioner Elizabeth Denham has been so vexed by the issue that she has published her first Commissioner’s Opinion [PDF] to help police understand the law around data protection.

“Live facial recognition is a step change in policing techniques; never before have we seen technologies with the potential for such widespread invasiveness.

“The results of that investigation raise serious concerns about the use of a technology that relies on huge amounts of sensitive personal information,” wrote Information Commissioner Elizabeth Denham.

She argues that the absence of a statutory code specifically addressing the use of live facial recognition, and the legal and moral challenges it entails, will end-up undermining public confidence. 

The proposed code will “give the police and the public enough knowledge as to when and how the police can use live facial recognition systems in public spaces”, Denham wrote, adding that the ICO will now work with the Home Office, the Investigatory Powers Commissioner, the Biometrics Commissioner, the Surveillance Camera Commissioner and policing bodies on the new code.

In addition, Denham called for more development work to be done on the algorithms in a bid to eliminate bias, particularly ethnic biases.

In her Commissioner’s Opinion, Denham “makes clear that there are well-defined data protection rules which police forces need to follow before and during deployment of live facial recognition.

“The Opinion recognises the high statutory threshold that must be met to justify the use of live facial recognition, and demonstrate accountability, under the UK’s data protection law.

“That threshold is appropriate considering the potential invasiveness of this technology. My Opinion also sets out the practical steps police forces must take to demonstrate legal compliance.”

Not fining people ninety quid for looking the other way when the police point the camera on them would be a start. 

Actually the understanding the law, data protection and things like that would be a bonus. 

Further reading

Source: Ico Search Results
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ICO to police: Live facial recognition ‘raises serious concerns’

ICO to police: Live facial recognition ‘raises serious concerns’

Police in South Wales have led the way in trialing live facial recognition

The Information Commissioner’s Office (ICO) has issued a warning to police over the use of live facial recognition.

It has called for a statutory code of practice to be introduced to govern police user of live facial recognition, after an investigation conducted by the ICO found that the “current combination of laws, codes and practices” were insufficient.

And the Information Commissioner Elizabeth Denham also issued her first Commissioner’s Opinion [PDF] clarifying the data protection issues of live facial recognition.

Never before have we seen technologies with the potential for such widespread invasiveness

The ICO investigation focused on the trials by Metropolitan Police and South Wales Police into facial recognition, conducted in public in recent years.

“Live facial recognition is a step change in policing techniques; never before have we seen technologies with the potential for such widespread invasiveness.

“The results of that investigation raise serious concerns about the use of a technology that relies on huge amounts of sensitive personal information,” wrote Information Commissioner Elizabeth Denham.

She argues that the absence of a statutory code specifically addressing the technology, and the legal and moral challenges, will end-up undermining public confidence.

The proposed code will “give the police and the public enough knowledge as to when and how the police can use live facial recognition systems in public spaces”, Denham wrote, adding that the ICO will now work with the Home Office, the Investigatory Powers Commissioner, the Biometrics Commissioner, the Surveillance Camera Commissioner and policing bodies on the new code.

There are well-defined data protection rules which police forces need to follow before and during deployment of live facial recognition

In addition, Denham called for more development work to be done on the algorithms in a bid to eliminate bias, particularly ethnic biases.

In her Commissioner’s Opinion, Denham “makes clear that there are well-defined data protection rules which police forces need to follow before and during deployment of live facial recognition. The Opinion recognises the high statutory threshold that must be met to justify the use of live facial recognition, and demonstrate accountability, under the UK’s data protection law.

“That threshold is appropriate considering the potential invasiveness of this technology. My Opinion also sets out the practical steps police forces must take to demonstrate legal compliance.”

The police deployment of live facial recognition in public places has provoked some opposition. In London, a man was levied with a £90 on-the-spot fine for covering up as he passed by a facial recognition camera, while a legal challenge against South Wales Police’s trial failed when the High Court in London ruled it lawful.

However, the Biometrics Commissioner has criticised police forces’ “chaotic” use of live facial recognition, while the Metropolitan Police has been criticised for deploying a system that has been described as highly inaccurate.

Further reading

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Golix’s ICO Didn’t Raise Millions But Thousands

BitFinance renamed to Golix

After exclusively breaking the story regarding the loss of a US$250k password by Golix’s CEO it turns out more information is finding its way to us through anonymous sources who dealt with Golix in one way or another in the aftermath of their bust-up with the RBZ.

Another source has now come out and said that Golix’s token sale was in the thousands meaning the company might have missed their U$32 million target by a longshot.

In fact, the source says Golix sold tokens closer to US$15 000 more than anything else and this same figure was shown to some customers. The source claims they saw the portal that was being used to handle the token sale so they believe that this figure is closer to the total amount made by the cryptocurrency exchange during the token sale.

Considering that Golix intended to use these funds to increase their presence in other countries and it doesn’t seem that materialised coupled with the fact that the token sale was held during the RBZ vs Golix crisis – it’s reasonable to believe that the token sale might have been a complete failure.

Considering that during the token sale Golix put the above poster on their site, one wonders whether this was an effort to paint a positive picture and influence the few who ended up buying the coin to invest more.

After the ICO was over Golix CEO Tawanda Kembo said that the GLX Token had sold 65% of tokens but refused to disclose the amount they made.

Unless Kembo decides to make himself available for comment and actually explain what happened, this is the version of events we have right now.


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Facebook ends appeal against ICO micro-fine: Admit liability? Never. But you can have £500k

Facebook has ended its appeal against the UK Information Commissioner’s Office and will pay the outstanding £500,000 fine for breaches of data protection law relating to the Cambridge Analytica scandal.

Prior to today’s announcement, the social network had been appealing against the fine, alleging bias and requesting access to ICO documents related to the regulator’s decision making. The ICO, in turn, was appealing a decision that it should hand over these documents.

The issue for the watchdog was the misuse of UK citizens’ Facebook profile information, specifically the harvesting and subsequent sale of data scraped from their profiles to Cambridge Analytica, the controversial British consulting firm used by US prez Donald Trump’s election campaign.

The app that collected the data was “thisisyourdigitallife”, created by Cambridge developer Aleksandr Kogan. It hoovered up Facebook users’ profiles, dates of birth, current city, photos in which those users were tagged, pages they had liked, posts on their timeline, friends’ lists, email addresses and the content of Facebook messages. The data was then processed in order to create a personality profile of the user.

“Given the way our platform worked at the time,” Zuck has said, “this meant Kogan was able to access tens of millions of their friends’ data”. Facebook has always claimed it learned of the data misuse from news reports, though this has been disputed.

Both sides will now end the legal fight and Facebook will pay the ICO a fine but make no admission of liability or guilt. The money is not kept by the data protection watchdog but goes to the Treasury consolidated fund and both sides will pay their own costs. The ICO spent an eye-watering £2.5m on the Facebook probe.

Facebook’s at it again: Internal emails show it knew about Cambridge Analytica abuse ‘months’ before news broke

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Facebook can also keep documents handed over the ICO, which it claims will help restart its investigation into Cambridge Analytica – parts of which had been put on hold on ICO instructions.

The agreement centres on Facebook’s action in handing UK citizens’ data to Cambridge Analytica and the ICO’s larger investigation into the misuse of private data for political purposes. This also saw campaign group Leave.eu fined a total of £60,000 for data offences.

Deputy commissioner of the ICO James Dipple-Johnstone said: “The ICO welcomes the agreement reached with Facebook for the withdrawal of their appeal against our Monetary Penalty Notice and agreement to pay the fine. The ICO’s main concern was that UK citizen data was exposed to a serious risk of harm. Protection of personal information and personal privacy is of fundamental importance, not only for the rights of individuals, but also as we now know, for the preservation of a strong democracy.”

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$0.75 – about how much Cambridge Analytica paid per voter in bid to micro-target their minds, internal docs reveal

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In October 2018 the ICO imposed a fine of £500,000 on Facebook, which equates to about 17 minutes’ profit for the firm – the maximum possible fine because the offences occurred between 2013 and 2015. Under the European General Data Protection Regulation (GDPR) brought in last year, however, Facebook could be fined 4 per cent of its $56bn global turnover.

ICO commissioner Elizabeth Denham has previously defended the massive spending on the Facebook investigation as giving the watchdog ammunition to go to government and get stronger enforcement powers. ®

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Facebook strikes deal with ICO over Cambridge Analytica

Facebook strikes deal with ICO over Cambridge Analytica

Facebook has long been accused of playing fast-and-loose with users’ personal data

Facebook has reached a deal with the Information Commissioner’s Office (ICO) over the misuse of personal data by Cambridge Analytica. The company will pay the £500,000 fine originally proposed by the ICO – the maximum it could legally levy, pre-GDPR – but without acknowledging responsibility.

Facebook had appealed against the sum set out in the ICO’s monetary penalty notice. Despite not acknowledging responsibility, it did admit that it could have done more and sooner, and claimed that it regretted not doing so.

ICO deputy commissioner James Dipple-Johnstone said: “The ICO’s main concern was that UK citizen data was exposed to a serious risk of harm. Protection of personal information and personal privacy is of fundamental importance, not only for the rights of individuals but also as we now know, for the preservation of a strong democracy.”

Cambridge Analytica acquired the personal data of 87 million Facebook users in 2015 via data scientist Aleksandr Kogan, who devised a quiz entitled ‘This is Your Digital Life’ in the form of a Facebook app. This app was purportedly devised, and therefore approved by Facebook, for academic purposes, but instead provided by Kogan to Cambridge Analytica.

Furthermore, not only did the app Hoover up the personal information of everyone who took the quiz – all their data, not just their quiz responses – it also collected the personal information of those people’s Facebook friends.

In this way, Cambridge Analytica was able to acquire the personal information of some 87 million Facebook users – 70.6 million believed to be in the US. According to Facebook, the exfiltrated information included “public profile, page likes, birthday and current city”.

Cambridge Analytica went on to work, briefly, with the presidential campaigns of Ted Cruz and the eventual winner of the 2016 US presidential election, Donald Trump. However, the directors of both campaigns quickly concluded that Cambridge Analytica’s technology had been oversold.

President Obama, in 2012, had also used a Facebook app to acquire the personal information, not just of supporters who signed-up for the app, but also their Facebook friends lists.

“If a person signed on to Dashboard [the Obama campaign’s 2012 Facebook app] through his or her Facebook account, the campaign could, with permission, gain access to that person’s Facebook friends,” The Washington Post reported in 2013.

It continued: “The Obama team called this ‘targeted sharing’. It knew from other research that people who pay less attention to politics are more likely to listen to a message from a friend than from someone in the campaign.

“The team could supply people with information about their friends based on data it had independently gathered. The campaign knew who was and who wasn’t registered to vote. It knew who had a low propensity to vote. It knew who was solid for Obama and who needed more persuasion — and a gentle or not-so-gentle nudge to vote.

“Instead of asking someone to send a message to all of his or her Facebook friends, the campaign could present a hand-picked list of the three or four or five people it believed would most benefit from personal encouragement.”

Facebook has since tightened-up its policies around apps and their access to personal data, belatedly suspending tens of thousands of apps last month. And in contrast to the £500,000 pre-GDPR fine levied by the ICO on Facebook, the US Federal Trade Commission earlier this year hit the company with a $5 billion fine over the affair, which contravened the terms of an earlier consent decree over the misuse of personal data.

Further reading

Source: Ico Search Results
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Facebook drops appeal against GBP 500,000 fine imposed by ICO

The UK Information Commissioner’s Office (ICO) and Facebook have reached an agreement over a GBP 500,000 fine imposed for breaching data protection regulations relating to lawful processing of data and data security.

Facebook and the ICO have both agreed to withdraw their respective appeals. Facebook has agreed to pay the fine, but has not made an admission of liability in relation to the monetary penalty notice (MPN). 

Both parties will pay their own legal costs, and Facebook can retain documents disclosed by the ICO during the appeal for other purposes, including extending its investigation into Cambridge Analytica. The ICO said it believes that this agreement best serves the interest of all UK Facebook users. 

Source: Ico Search Results
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Tom Watson wants CMA, ICO to examine Google, Fitbit deal

The UK’s Shadow Digital, Culture, Media & Sport Secretary, Labour MP Tom Watson, has written to the Competition & Markets Authority (CMA) calling for it to block Google’s reported takeover of Fitbit, calling it a ‘data grab’, reports The Guardian.

Watson wants the CMA to block any deal pending completion of a full investigation into the dominance of major technology players like Google and Facebook over online platforms and digital advertising. He expressed deep concerned about the market dominance of these multi-national technology groups, which collect massive amounts of personal data on users to sell to advertisers, and remain ‘unaccountable and unregulated’. 

Watson has also sent a letter to the Information Commissioner’s Office (ICO) expressing concern about the deal. He wants the ICO to examine if the reported acquisition raises privacy questions and then report back to the CMA. 

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BioPharma Snapshot: New Growth Strategies Continue for the Industry – (TSXV: $ICO.V) (OTCQB: $ICOTF) (NASDAQ: $ALXN) (NASDAQ: $BIIB) (NASDAQ: $ACHN) (NASDAQ: $PRVB)

(MENAFN – Investor Ideas) Point Roberts, WA and Delta, BC – October 29, 2019 (Investorideas.com Newswire) Investorideas.com, a leading investor news resource covering pharmaceutical and biotech stocks releases a sector snapshot reporting on the growth of the global monoclonal antibody market and how this is affecting industry decisions moving forward.

Why is this a sector to pay attention to? According to recentindustry reports , “The Monoclonal Antibodies market worldwide is projected to grow by US$47.6 Billion, driven by a compounded growth of 6%.. Poised to reach over US$44.3 Billion by the year 2025, Inflammatory Disease will bring in healthy gains adding significant momentum to global growth.”

As this segment of bio/pharma grows in size and scale, we are seeing it become a more prominent focus for many companies in the industry. At present, the global Monoclonal Antibody Based Products market is chiefly driven by a number of outstanding firms and the major market players are beginning to execute different growth strategies including new product launches, strategic partnerships & collaborations, operational & geographical expansions, joint ventures, mergers & acquisitions and sales to grab a superior business position. Key players include Abbott Diagnostics, Inc., Amgen, Inc., AstraZeneca PLC, Bristol-Myers Squibb Company and Eli Lilly and Company.

Is there room for smaller players?

iCo Therapeutics Inc. ( TSXV: ICO ) ( OTCQB: ICOTF ) thinks so. The Company, which identifies existing development stage assets for use in underserved ocular and infectious diseases,recently announcedseveral corporate developments related to their monoclonal antibody product, Bertilimumab.

iCo has been monitoring a current US court-mandated auction process, with respect to systemic uses of Bertilimumab, previously sublicensed to Immune Pharmaceuticals. On October 21, 2019, the bankruptcy court in New Jersey approved a sale order relating to the assignment of the sublicense of iCo’s assets to Alexion Pharmaceuticals ( NASDAQ: ALXN ) . With respect to the court approved assignment to Alexion, iCo did not object and their rights as the sub-licensor will continue under the sublicense agreement if Alexion acquires the asset in accordance with terms submitted to the bankruptcy court. Further approval by Israeli courts will be required. The company expects in the coming weeks to comment on outcomes, a potential new partnership and next steps for this asset.

Bertilimumab is a fully human monoclonal antibody with specificity for human eotaxin-1 and inhibits its function.

Favorable results from pre-clinical assessments resulted in three clinical studies of Bertilimumab conducted in the EU (a total of 126 patients – healthy individuals, patients with a history of seasonal allergic rhinitis and individuals with a history of seasonal allergic conjunctivitis) provided evidence of good safety and tolerability of Bertilimumab when administered by the intravenous (IV) or intranasal route as well as topical application to the eye.

More recently, Bertilimumab has been investigated in two Phase 2 trials. The first trial targeted patients with a skin condition called bullous pemphigoid and revealed good safety and efficacy results. A second trial has been carried out in patients with an inflammatory bowel disease called ulcerative colitis. Results from this trial are still pending. A Phase 2 clinical trial for patients with vernal keratoconjunctivitis and/or atopic keratoconjunctivitis (involving cornea and conjunctiva) is in preparation. A number of other indications have also been considered.

Therapy with Bertilimumab could be useful in treatments of a number of diseases where steroids and immune-suppressants or other drugs may need to be prescribed chronically (a number of these diseases appear to be seasonal), often resulting in adverse reactions that may become serious over time.

Separately, iCo has also solicited bids from CROs for assistance with iCo’s wholly-owned ocular Bertilimumab asset. Currently the company expects to engage the Food and Drug Administration regarding an additional Phase 2 study in ophthalmology, to be run by the Company and/or prospective partners.

Biogen Inc. ( NASDAQ: BIIB ) and Eisai, Co., Ltd. recently announcedthat, after consulting with the US FDA, Biogen plans to pursue regulatory approval for Aducanumab, an investigational treatment for early Alzheimer’s disease (AD). Aducanumab is a monoclonal antibody that is supposed to prevent or slow down neurodegeneration by removing toxic beta-amyloid plaques from the brain in the early stages of this condition.

The Phase 3 EMERGE Study met its primary endpoint showing a significant reduction in clinical decline, and Biogen believes that results from a subset of patients in the Phase 3 ENGAGE Study who received sufficient exposure to high dose Aducanumab support the findings from EMERGE. Patients who received Aducanumab experienced significant benefits on measures of cognition and function such as memory, orientation, and language. Patients also experienced benefits on activities of daily living including conducting personal finances, performing household chores such as cleaning, shopping, and doing laundry, and independently traveling out of the home. If approved, Aducanumab would become the first therapy to reduce the clinical decline of Alzheimer’s disease and would also be the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.

In thenews , “Shares of Biogen surged significantly after it announced new data on Aducanumab in patients with early Alzheimer’s disease (AD). The company released results from a new analysis of a larger dataset of the discontinued ENGAGE and EMERGE phase III studies on Aducanumab in patients with early AD. This analysis was conducted in consultation with the FDA. Biogen and Japanese partner Eisai had discontinued ENGAGE and EMERGE studies, following a futility analysis. Nevertheless, the new data showed that Aducanumab reduced clinical decline of Alzheimer’s disease in such patients as measured by the pre-specified primary and secondary endpoints. Based on this data, the company plans to submit a biologics license application seeking approval of the drug to the FDA in early 2020. The company also reported better-than-expected results for the third quarter of 2019, driven by higher sales of key multiple sclerosis drugs and continued global launch of spinal muscular atrophy drug, Spinraza.”

Based on discussions with the FDA, the Company plans to file a Biologics License Application (BLA) in early 2020 and will continue dialogue with regulatory authorities in international markets including Europe and Japan. The BLA submission will include data from the Phase 1/1b studies as well as the complete set of data from the Phase 3 studies.

The Company aims to offer access to Aducanumab to eligible patients previously enrolled in the Phase 3 studies, the long-term extension study for the Phase 1b PRIME study, and the EVOLVE safety study. Biogen will work towards this goal with regulatory authorities and principal investigators with a sense of urgency.

Biogen isn’t the only company to surge on recent developments, as inrecent news , “Shares of Achillion Pharmaceuticals Inc. ( NASDAQ: ACHN ), rocketed 82% in premarket trading Wednesday (October 16th), after the biopharmaceutical company agreed to be acquired by Alexion Pharmaceuticals Inc. in a cash deal valued at $930 million. Under the terms of the deal, Alexion will pay $6.30 for each Achillion share outstanding, which is 73% above Tuesday’s closing price of $3.65 and implies a market-capitalization of $880.05 million. The deal also includes potential for an additional payment for Achillion shares in the form of contingent value rights (CVRs) to be paid if certain clinical and regulatory milestones are achieved. The CVRs include $1 a share for U.S. Food and Drug Administration approval of Danicopan and $1 a share for ACH-5228 phase 3 initiation.”

Danicopan, Achillion’s lead drug candidate has received breakthrough therapy designation for treatment in combination with a C5 monoclonal antibody for patients with a rare blood disorder, paroxysmal nocturnal hemoglobinuria (PNH).

Provention Bio, Inc. ( NASDAQ: PRVB ), a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases,recently announcedthat the European Medicines Agency (EMA) has granted PRV-031 (Teplizumab) PRIority MEdicines (PRIME) designation for the prevention or delay of clinical type 1 diabetes (T1D) in individuals at-risk of developing the disease.

PRIME designation is awarded by the EMA to promising medicines that demonstrate the potential to address substantial unmet medical need based on clinical data. The EMA considers PRIME designations a priority and provides them with special support, including enhanced interactions and dialogue, as well as a pathway for accelerated evaluation and review.

“We are very pleased the EMA recognizes the transformative potential of PRV-031 and has granted this groundbreaking therapy PRIME designation”, said Ashleigh Palmerm CEO of Provention Bio. “Following on the heels of Breakthrough Therapy Designation from the FDA in August, EMA PRIME further validates the rationale for PRV-031 to prevent or delay the onset of clinical T1D in at-risk subjects. We are committed to working closely with both regulatory agencies to bring PRV-031, as quickly as possible, to the many thousands of T1D at-risk individuals who currently have no options to prevent or delay this catastrophic disease.”

PRV-031’s PRIME designation was based on clinical data from the “At-Risk” Study conducted by TrialNet, which demonstrated that a single 14-day course of PRV-031 significantly delayed the onset of T1D, as compared to placebo, by a clinically-relevant median of at least 2 years in children and adults at high risk of developing clinical T1D.

PRV-031, also known as Teplizumab, is an anti-CD3 monoclonal antibody (mAb), which is being developed for the interception and prevention of type 1 diabetes (T1D). The candidate has been the subject of multiple clinical studies involving more than 1,000 subjects with more than 800 patients receiving PRV-031 in those studies. In previous studies of newly diagnosed patients, PRV-031 has consistently demonstrated the capability of preserving beta cell function and reducing the need for exogenous insulin usage.

Provention is currently evaluating PRV-031 in patients newly diagnosed with clinical T1D (the Phase 3 PROTECT Study). Additional information on the clinical trial is available atwww.clinicaltrials.gov.

As the Monoclonal Antibodies market worldwide is projected to grow by US$47.6 Billion, driven by a compounded growth of 6% with inflammatory disease displaying the potential to grow at over 6.4%, the shifting dynamics supporting this growth make it critical for businesses in this space to keep abreast of the changing pulse of the market.

About Investorideas.com – News that Inspires Big Investing Ideas Investorideas.com is a recognized news source publishing third party news, research and original financial content. Learn about investing in stocks and sector trends with our news alerts, articles,podcastsand videos, looking at cannabis, crypto, AI and IoT, mining, sports biotech, water, renewable energy and more. Investor Idea’s original branded content includes the following podcasts and columns :Crypto Corner,Play by Playsports and stock news column,Investor Ideas PotcastsCannabis News and Stocks on the Move podcast and column, Cleantech and Climate Change,Exploring Mining , theAI Eye.

Disclaimer/Disclosure: Investorideas.comis a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions. Disclosure: this news article featuring ICOTF is a paid for news release on Investorideas.com – third party (two thousand) More disclaimer info:https://www.investorideas.com/About/Disclaimer.aspLearn more about publishing your news release and our other news services on the Investorideas.com newswirehttps://www.investorideas.com/News-Upload/andtickertagstocknews.comGlobal investors must adhere to regulations of each country. Please read Investorideas.com privacy policy:https://www.investorideas.com/About/Private_Policy.asp

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