Daily Archives: June 16, 2023

There’s Now an OTC Gel for Erectile Dysfunction

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Futura Medical is a UK-based pharmaceutical. The company’s flagship development is a proprietary gel technology called DermaSys, and its first launch product based on the tech is a treatment for erectile dysfunction. The ED gel has been codenamed MED3000 but it will be sold under the name Eroxon. It’s classified as a medical device and will not require a prescription to obtain.

Eroxon is said to work by containing volatile solvents that evaporate when applied to the glans, the head of the penis. These solvents create a quickly cooling and then warming effect that stimulates the highly sensitive nerves of the penis, which then leads to a boost in the production of nitric oxide, a molecule with many roles in the body—including the relaxation of smooth muscle and increased blood flow in the penis that makes an erection possible.

The pivotal phase III clinical trial that secured the FDA’s authorization involved about 100 men with mild to severe ED. The men were randomized to receive the gel or the lowest prescribed dose of oral tadalafil, the active ingredient in the popular ED drug Cialis.

The trial met all of the primary and secondary goals, with the gel significantly improving men’s erectile function on average. The gel was overall less effective than tadalafil, but its effects were felt much sooner, working within 10 minutes (it typically takes at least a half hour for tadalafil and similar ED treatments). And while both drugs were safe to take, Eroxon also appeared to provide far fewer side effects. Headaches, one of the most common adverse events in the trial, were experienced by four percent of Eroxon users, compared to about 20% of tadalafil users. About one percent of Eroxon users reported a localized burning sensation as well.

The FDA’s go-ahead is the latest victory for the company and MED3000. The gel has already received authorization from the European Union, the UK, and parts of the Middle East. It has since launched in the UK, where it’s being sold as a package of four doses for about $30. The company is also expected to launch the gel in physical EU stores sometime this year. But there isn’t a clear launch timeline or pricing for the product in the U.S. just yet. According to CNN, some financial analysts predict that it might take until 2025 for Americans to get their hold on Eroxon.

Source: There’s Now an OTC Gel for Erectile Dysfunction

MEPs ready to negotiate first-ever rules for safe and transparent AI after passing AI act in Parliament

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The rules aim to promote the uptake of human-centric and trustworthy AI and protect the health, safety, fundamental rights and democracy from its harmful effects.

On Wednesday, the European Parliament adopted its negotiating position on the Artificial Intelligence (AI) Act with 499 votes in favour, 28 against and 93 abstentions ahead of talks with EU member states on the final shape of the law. The rules would ensure that AI developed and used in Europe is fully in line with EU rights and values including human oversight, safety, privacy, transparency, non-discrimination and social and environmental wellbeing.

Prohibited AI practices

The rules follow a risk-based approach and establish obligations for providers and those deploying AI systems depending on the level of risk the AI can generate. AI systems with an unacceptable level of risk to people’s safety would therefore be prohibited, such as those used for social scoring (classifying people based on their social behaviour or personal characteristics). MEPs expanded the list to include bans on intrusive and discriminatory uses of AI, such as:

  • “Real-time” remote biometric identification systems in publicly accessible spaces;
  • “Post” remote biometric identification systems, with the only exception of law enforcement for the prosecution of serious crimes and only after judicial authorization;
  • biometric categorisation systems using sensitive characteristics (e.g. gender, race, ethnicity, citizenship status, religion, political orientation);
  • predictive policing systems (based on profiling, location or past criminal behaviour);
  • emotion recognition systems in law enforcement, border management, the workplace, and educational institutions; and
  • untargeted scraping of facial images from the internet or CCTV footage to create facial recognition databases (violating human rights and right to privacy).

High-risk AI

MEPs ensured the classification of high-risk applications will now include AI systems that pose significant harm to people’s health, safety, fundamental rights or the environment. AI systems used to influence voters and the outcome of elections and in recommender systems used by social media platforms (with over 45 million users) were added to the high-risk list.

Obligations for general purpose AI

Providers of foundation models – a new and fast-evolving development in the field of AI – would have to assess and mitigate possible risks (to health, safety, fundamental rights, the environment, democracy and rule of law) and register their models in the EU database before their release on the EU market. Generative AI systems based on such models, like ChatGPT, would have to comply with transparency requirements (disclosing that the content was AI-generated, also helping distinguish so-called deep-fake images from real ones) and ensure safeguards against generating illegal content. Detailed summaries of the copyrighted data used for their training would also have to be made publicly available.

Supporting innovation and protecting citizens’ rights

To boost AI innovation and support SMEs, MEPs added exemptions for research activities and AI components provided under open-source licenses. The new law promotes so-called regulatory sandboxes, or real-life environments, established by public authorities to test AI before it is deployed.

Finally, MEPs want to boost citizens’ right to file complaints about AI systems and receive explanations of decisions based on high-risk AI systems that significantly impact their fundamental rights. MEPs also reformed the role of the EU AI Office, which would be tasked with monitoring how the AI rulebook is implemented.

Quotes

After the vote, co-rapporteur Brando Benifei (S&D, Italy) said: “All eyes are on us today. While Big Tech companies are sounding the alarm over their own creations, Europe has gone ahead and proposed a concrete response to the risks AI is starting to pose. We want AI’s positive potential for creativity and productivity to be harnessed but we will also fight to protect our position and counter dangers to our democracies and freedoms during the negotiations with Council”.

Co-rapporteur Dragos Tudorache (Renew, Romania) said: “The AI Act will set the tone worldwide in the development and governance of artificial intelligence, ensuring that this technology, set to radically transform our societies through the massive benefits it can offer, evolves and is used in accordance with the European values of democracy, fundamental rights, and the rule of law”.

Next steps

Negotiations with the Council on the final form of the law will begin later today.

Source: MEPs ready to negotiate first-ever rules for safe and transparent AI | News | European Parliament

WhatsApp may finally let you add multiple accounts to one device

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If you regularly use people who regularly use more than one WhatsApp account this new beta update is going to be of interest to you. The messaging app is reportedly working on multi-account support for its Android app, an update that would allow you to switch between profiles on the same device, WABetaInfo reports. The feature appears to work just like changing accounts on fellow Meta-owned app Instagram with a pop-up at the bottom of your app showing current accounts and the option to add new ones.

Any new accounts will be stored within your device and, of course, can be logged out of at any point. Multi-account support might be advantageous if you have different work and personal numbers or want to try out recent social media-centric WhatsApp features like Channels. This update lets you send broadcasts like photos and polls to followers, with WhatsApp planning to monetize it for creators in the future. Similarly, WhatsApp has reportedly been working on a username feature that would allow you to find people the same as Instagram or Twitter, without having their phone numbers.

Multi-account support also follows the iOS and Android release of companion mode, an update that allows you to use the same WhatsApp account on up to four phones. Previously, you could only be logged in on a single mobile phone along with your tablet and computer.

Source: WhatsApp may soon let you add multiple accounts to one device | Engadget

Broadcom squeezed Samsung, now South Korea’s squeezing back

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As the Commission explained in a Tuesday adjudicaiton, Broadcom and Samsung were in talks for a long-term supply agreement when the American chipmaker demanded the Korean giant sign or it would suspend shipments and support services.

Broadcom share price pops on VMware rumors
Broadcom’s share price jumped from $805 to $860 on Tuesday, after Reuters reported EU regulators will sign off on its acquisition of VMware.The newswire reported that proposed remedies to ensure competition in the market for host bus adapters found approval from EU regulators. The deal is yet to be approved by UK and US authorities.

Broadcom also wanted Samsung to commit to spending over $760 million a year, to make up the difference for any shortfalls, and not to buy from rivals.

With the market for the components it needs tight, Samsung reportedly signed. Then, when a certain viral pandemic cruelled its business, the giant conglomerate found itself having to buy parts it didn’t need. The chaebol estimates the deal cost it millions.

News of the deal eventually reached the regulator, which in 2022 asked Broadcom to propose a remedy – a common method of dispute resolution in South Korea.

Broadcom proposed a $15.5 million fund to stimulate South Korea’s small semiconductor outfits, plus extra support for Samsung.

On Tuesday, the Commission decided that’s not a reasonable restitution because it doesn’t include compensation for the impacted parties.

That’s bad news for Broadcom, because it means the regulator will now escalate matters – first by determining if the chipmaker broke local laws and then by considering a different penalty.

South Korea is protective of its local businesses – even giants like Samsung that are usually capable of fending for themselves. Broadcom reps will soon have some tricky-to-negotiate meetings on their agendas.

At least the corporation’s legal team has experience at this sort of thing. In 2018 it was probed by US authorities over contract practices, and in 2021 was forced to stop some anticompetitive practices. In 2022 it was in strife again – this time for allegedly forcing its customers to sign exclusive supply contracts.

The serial acquirer also lost a regulatory rumble over its attempted acquisition of Qualcomm, and is currently trying to explain why its proposed acquisition of VMware won’t harm competition.

Now it awaits South Korea’s wrath – and perhaps Samsung’s too.

Source: Broadcom squeezed Samsung, now South Korea’s squeezing back • The Register

Google Restores ‘Downloader’ App To Store 20 days after DMCA takedown based on 0 evidence, says it’s normal to be able to take down apps for no reason

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A couple of weeks back, we discussed how Google had delisted the app Downloader from the Play Store after a DMCA notice was issued by a firm representing several Israeli TV networks. The problem with all of this is simple: Downloader doesn’t have anything to do with copyright infringement or piracy. All it does is combine a file manager and basic web browser. The DMCA notice centered on the latter, complaining that users could get to piracy sites from the browser. You know, just like you can from any browser.

Well, take heart, dear friends, because Google reinstated Downloader on the Play Store 20 days after it was removed.

Google has reversed the suspension of an Android TV app that was hit with a copyright complaint simply because it is able to load a pirate website that can also be loaded in any standard web browser. The Downloader app, which combines a web browser with a file manager, is back in the Google Play Store after nearly a three-week absence.

In addition to the rejected appeal, Saba filed a DMCA counter-notification with Google. That “started a 10-business-day countdown for the [TV companies’] law firm to file legal actions against me,” Saba wrote today. “Due to the app being removed on a Friday and the Memorial Day holiday, 10 business days had elapsed with no word from the law firm on June 6th and I contacted Google to have the app reinstated.”

All of which is why Google, further down the article, is quoted as saying they followed the standard playbook to DMCA takedown notices. The counter-notification kicked off that process, giving the firm that issued the original notice time to decide whether to file a lawsuit or not, which it presumably did not. The quote has all the hallmarks of Google resting on that process to wipe its hands clean of the whole situation.

But that’s stupid. It also serves as an example proving Saba’s point: the DMCA takedown process is broken. That a bunch of foreign TV networks can get a perfectly legit app removed from the app store for weeks just by pushing paperwork around is absurd.

As is Google’s continued inability to get things right with regard to this particular app.

In yet another example of the Google Play Store’s absurdity, Google had determined that my app collected email addresses without declaring so. Since there is no way for my app itself to collect email addresses, and without any additional information or help from Google, I can only assume that Google is referring to the email mailing list signup form on this website, which loads by default in the web browser of the Downloader app.

Once again, that isn’t the app doing a thing; it’s the web browser doing it if someone signs up to be on an email list.

So, the app is back, a lawsuit has not yet been filed, and everyone will probably forget about this entire thing, meaning the broken nature of the DMCA process will remain broken. Bang up job all around.

Source: Google Finally Restores ‘Downloader’ App To Store