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Choose Your Weapon: Senate Amendment Pits ANDA/BPCIA Pathway Against Post-Grant Proceedings

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Per Senator Orrin Hatch, the America Invents Act has disrupted the “careful balance” he struck with Senator Waxman in the development of the decades-old Hatch-Waxman Act governing the adjudication of generic drug litigation. On June 13, 2018, Senator Hatch filed an amendment in the Senate Judiciary Committee to remedy the perceived conflict between the “carefully calibrated requirements” of Abbreviated New Drug Application (“ANDA”) litigation under the Hatch-Waxman Act and the “much blunter instrument” of post-grant proceedings before the United States Patent Trial and Appeal (“PTAB”).   According to Senator Hatch, the amendment “will ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop low-cost drugs while at the same time ensuring brand-name companies have sufficient protections in place to recoup their investments.”  A press release of Senator Hatch’s remarks is available here.

The “Hatch-Waxman Integrity Act” by Senator Hatch is an amendment to the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act), legislation designed to help generic drug companies acquire the samples they need to develop generic drugs, particularly for products subject to a risk evaluation and mitigation strategy (“REMS”). The CREATES Act advanced to the Senate from the Judiciary Committee on June 14, 2018, and was been placed on the Senate Legislative Calendar on June 21, 2018.

The Amendment would add to the CREATES Act a section entitled “Preventing the Inter Partes Review Process for Challenging Patents from Diminishing Competition in the Pharmaceutical Industry and with Respect to Drug Innovation; Preventing the Manipulative and Deceptive Use of Inter Partes Review.” The section has three parts and targets both generic drug manufacturers and biosimilar companies.

In the first portion of the Amendment, an ANDA applicant must certify that they have not and will not file an Inter Partes Review (“IPR”) or Post-Grant Review (“PGR”) or forfeit the ability to participate in the Hatch-Waxman litigation procedures.  Additionally, the ANDA applicants must certify that they are not relying in whole or in part on any decision reached by the PTAB in an IPR or PGR proceeding.

Second, the Amendment forces a similar choice for biosimilar applicants.  Those who file an abbreviated Biologics License Application (“aBLA”) must decide, with respect to any patent that is or could be included in the lists of patents that are exchanged as part of the “Patent Dance,” whether to challenge patents in an IPR/PGR or take the path outlined in the Biologics Price Competition and Innovation Act (“BPCIA”).

Third, the Amendment aims to end certain market practices and appears to apply broadly to all parties filing for post grant proceedings. To “prevent[] the Manipulative and Deceptive Use of Inter Partes Review,” the Hatch-Waxman Integrity Act amends the Securities Exchange Act of 1934 to address market manipulation tied to inter partes review petitions, such as that attempted by the Coalition for Affordable Drugs.  Specifically, “a person shall be considered to be using a manipulative or deceptive device” if they file a petition for an IPR and engage in a short sale of any publicly traded security of the owner of the patent at issue in the IPR for the 90 days before and after the filing of the petition.

We will continue to monitor the CREATES Act and the Hatch-Waxman Integrity Act in the future. For more information, please feel free to contact Jamaica Potts Szeliga at any time.

Source: https://www.bioloquitur.com/choose-weapon-senate-amendment-pits-anda-bpcia-pathway-post-grant-proceedings/

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Algorand Price Analysis: ALGO retraces to $1.79, bearish momentum persists

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TL;DR Breakdown

  • Algorand price analysis is bearish for today.
  • ALGO/USD saw large volatility again over the past 24 hours.
  • ALGO resists further upside at $2.00.

The price of Algorand is bearish for today, as the market was unable to move past the $2.00 mark after a rapid climb during the last hours. As a result, we believe that ALGO/USD will retreat and attempt to test the $1.60 support base after setting a daily low of $1.7.

Over the last 24 hours, the cryptocurrency market has largely been declining. Bitcoin dropped 4.15%, while Ethereum went down by 6.6%. Cardano lost 7% to become the worst performer of the day. 

Algorand price movement in the last 24 hours: Algorand sets lower low

Algorand has been on an uptrend lately and topped charts as the best performer coin multiple times.  With the price climbing to heights not seen since early April. The ALGO/USD pair fluctuated between $1.79 and $2.02 throughout today’s session, showing significant volatility over the last day.

ALGO/USD 4-hour chart: ALGO set to reverse again?

On the 4-hour chart, we can see that the Algorand price is rejecting further upside, suggesting a reversal may be on the way.

Algorand Price Analysis: ALGO retraces to $1.79, bearish momentum persists 1
ALGO/USD 4-hour chart. Source: TradingView

The Algorand price has been consolidating in a wide range over the past week. After an incredible rise to $1.05 on September 7th, ALGO/USD began a several-day ascent.

On the 9th of September, resistance was discovered at $2.5, resulting in a profit of more than 140% in a few days. A steep drop to the $1.90 followed, with support being re-established and tested repeatedly over the following week.

On Monday, the price of Algorand rose once again, with the $2.5 only briefly broken, revealing that bears remain in command. The following decrease to the $2 level was followed by a consolidation period yesterday.

Algorand Price Analysis: Conclusion 

The Algorand price analysis is bearish for the next 24 hours, with a quick drop taking place to $1.79 followed by uncertainty in the past hours. As a result, we anticipate ALGO/USD to reverse once more and aim to test the $1.90 support again over the next 24 hours.

While waiting for Algorand to move further, read our articles on Wrapped Bitcoin, Decentralized Exchanges, as well as NFT Marketplace.

Disclaimer. The information provided is not trading advice. Cryptopolitan.com holds no liability for any investments made based on the information provided on this page. We strongly recommend independent research and/or consultation with a qualified professional before making any investment decisions.

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How Crypto Gambling Is Regulated Around the World

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The gambling industry is becoming more regulated and licensed around the world. There are strict guidelines in place at most gambling authorities, which are there to ensure player safety. Customers of online casinos and betting sites can now play without fear of their data being collected and sold to third parties. However, as we move into the realm of crypto gambling and cryptocurrency casino platforms, the issue of regulation begins to become more complicated.

How Does Cryptocurrency Gambling Work?

Generally, blockchain-based gambling occurs in two ways: on-chain and off-chain. The off-chain cryptocurrency gambling industry includes both physical and online casinos that accept cryptocurrency. To convert Bitcoins or other cryptocurrencies into local fiat currencies, these establishments will often use third-party custodians, such as BitPay. It is possible to find online casinos that operate exclusively without fiat currency and payout in Bitcoin.

A decentralized application that runs on a blockchain network, rather than traditional centralized servers, is the basis of on-chain gambling on a blockchain. Off-chain casinos are much easier for governments to pursue. The IP addresses of certain countries are often blocked by crypto casino websites. Users from the United States will likely be banned from accessing Bitcoin-accepting gaming sites.

The Netherlands and Crypto Gambling

Only a few countries are taking steps to regulate cryptocurrency use in online casinos so far. Some of them, such as the Netherlands, are still trying to legalize online gambling and many companies have applied for a license. They aim to be a new market for online casino platforms and businesses. That being said, the best that users can get right now are minimum deposit casino sites, which allow you to play by depositing just a single euro. Given how the regulatory system in the Netherlands is still young, they don’t have laws that explicitly forbid gambling on crypto casino platforms. 

This doesn’t mean that laws won’t change or that a better-defined protocol won’t be enforced at some point. As far as crypto is concerned, Dutch finance minister Wopke Hoekstra believes that regulation is more effective than banning it. 

Crypto Casinos in Canada

Canada is still in the process of improving its sports betting scene. It was a big step for them to allow single-event bets. As far as casino gaming goes it’s still illegal to offer that service there, but Canadians are free to play on any foreign platform, as the gambling itself is not forbidden. Meaning, Canadians can play at 5$ deposit casino sites or even on platforms that allow crypto payments. However, they do have cryptocurrency regulations and they do not allow unregistered crypto exchanges. They recently established their own regulated crypto exchange, so if you need to exchange your winnings you must do so through these sanctioned channels.  

Canadians, like many other countries, are partial to cryptocurrency gambling. A number of countries including Belgium, Italy, and Greece have started working on the regulatory framework for cryptocurrencies, but it still remains to be seen how successful their efforts will be. 

Crypto Regulations in the UK

In the gambling environment, the UK government is one of the first to attempt to impose some regulations, but it is still not recognized as legal tender, so it continues to face difficulties. Back in 2016, the UK government did pass a law that allows UK gaming operators to accept cryptocurrencies. It was agreed that any player wishing to use crypto at a licensed casino would need to present the proper identification documents, concerning all the AML and KYC procedures. The identity of crypto users poses the biggest challenge.

Crypto Regulations in the USA

In the United States, the gambling issue has always been complex. According to federal laws, crypto gambling online is not technically prohibited. In contrast, US gambling sites cannot conduct financial transactions with American residents. The tax implications of crypto gambling occur because cryptocurrency is viewed as a commodity. Players can bet using Bitcoin, for instance, but the profits will be taxed.

Summary

Various laws in every state are constantly changing and are summarized here for general purposes. Accordingly, Bitcoin will always be deregulated and players will be able to gamble online using it, but a close eye should always be kept on any new laws.

Disclaimer. This is a paid press release. Readers should do their own due diligence before taking any actions related to the promoted company or any of its affiliates or services. Cryptopolitan.com is not responsible, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with the use of or reliance on any content, goods or services mentioned in the press release.

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The rise of NFT scammers and how to protect yourself

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TL;DR Breakdown

  • NFTs have no replica, and copyrights belong solely to the owner
  • make sure you are not scammed when doing trade.

Scammers in NFTs

Non-fungible Tokens have been such a topic in both the art and the finance sectors of the economy. NFTs are tokens that deal with uniqueness as their determiner of value. They use the same technology as cryptocurrencies, but unlike cryptocurrencies, they have no replica, and copyrights belong solely to the owner of the NFT. After Jack Dorsey sold his first tweet at $2.9m, it set a great example to investors and artists and gave them ideas of what and where to trade in the form of NFTs. As fate would have it, some scammers saw this as an excellent opportunity to earn a massive amount of cash without doing much.

Is NFT a scam?

While some have begun investing in NFTs, some claim it to be a scam. The latter cling to their claims that some NFTs can be found on various websites for free. However, that is not the principle that NFTs work on. NFTs are owned because of their uniqueness. Taking an example of Beeple’s every day: THE FIRST 5000 DAYS, the creator Mike Winkelmann sold it to Vignesh Sundaresan (MetaKovan), who is now the owner of the piece but does not have copyrights on it. Fetching more than $69 million, the work must have been legitimate! NFTs are NOT a scam.

How one can get scanned

There are various ways that scammers can use to defraud you of your last cent! These include;

  • Hyping pieces of art to overvalue it. Since the art being dealt with is digital, it is hard to estimate the value.   Scammers could overestimate art because of its popularity and the buzz they have created around it. This leads to losses to other artists and wastage of money on an asset whose price has been exaggerated.
  • Use of stories similar to those of legitimate NFT dealers. They use these to lure interested NFT buyers into logging in with their credentials. Once this is done, hacking the account is easy. Scammers can also attract customers to giving their credit card information. 
  • Use of airdropping tokens and giveaways. Fraudsters can use links to lure clients into clicking links promising rewards and tickets. Some websites promise to multiply your money once you have sent a certain amount of money for ‘registration.’ 
  • Impersonation of brands. Scammers put up websites terming them as the support services or social media accounts for NTFs platforms. They also use these accounts to sell fake and non-existent NFTs.
  • Use of counterfeit NFTs and impersonation of artists. Artists like Derek Laufman and Devin Elle Kurtz woke up to stolen artwork. Their NFTs were sold on accounts that had their profiles but were not them. These cases have been reported on platforms like OpenSea, Rarible, and Audius. These are markets that artists can trade their NFTs. Some of these markets do not need verification of ownership before they mint them. When the proof is required, it is not difficult to fake. 

How to avoid getting scammed

To ensure that your art is safe and the transaction you are making is legitimate, one should follow guidelines.

  • Avoid clicking on links that you are not sure about. As a trader, one should not click on links whose source is not known. Some links lead to websites that are fraudsters’. Once you click on an unknown link, it could give hackers contact to your wallet.
  • Secure your password and username. It is important to note that no genuine person or organization is going to ask for your password. That is your secret as an investor and should remain so.
  • Conduct a personal search before transactions. An investor should carry out due diligence by searching for the NFT they wish to acquire. If the piece is on multiple websites, it is most probably that it is not legit. Authenticate accounts before carrying out transactions to verify their genuineness. 

As a trader, it is your role to make sure you are not scammed when doing trade. Following simple guidelines and being careful while doing business is vital!

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