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Biosimilar IPRs: Timing is Everything . . . But When is The Right Time?

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Timing the filing of an inter partes review for companies in the early stage of developing a biosimilar product should be carefully considered based on the recent Federal Circuit case, Momenta Pharmaceuticals, Inc. v Bristol-Myers Squibb Co., Appeal No. 2017-1694 (February 7, 2019). Momenta filed an IPR before the PTAB to challenge the validity of a BMS patent covering Orencia® (abatacept) while in its Phase I trials for its own biosimilar product. The PTAB instituted review, conducted trial, and sustained the validity of the BMS patent claims. During this period, however, Momenta’s own product failed its Phase I trials and subsequently decided to terminate its pursuit of the biosimilar to the abatacept product at that time. As an Article III court, the Federal Circuit held that Momenta’s decision to no longer pursue its biosimilar product rendered its standing to appeal the PTAB’s decision moot as there was no judiciable injury. Nevertheless, the question of when to file an IPR remains largely unanswered for a biosimilar manufacturer. Given the expense, duration, and uncertainty of getting approval, biosimilar companies will want to retain its right to appeal an adverse IPR decision. In contrast, an adverse IPR decision for the brand company is retained regardless of the status of the biosimilar. While the Court did not specifically address whether Momenta could have met its standing requirement if it remained actively pursuing its biosimilar, it is clear that the position of brand vs. biosimilar companies vastly contrast as the amici clearly established in this case.  According to BIO and PhRMA, the earliest time for a biosimilar company to have standing is upon the filing of its Biologics Licensing Application under the Biologics Price Competition and Innovation Act. Irrespective of the holding of Momenta, timing the filing of an IPR by a biosimilar company is a decision that may be best addressed by future cases that are directly on point.

Source: https://www.bioloquitur.com/biosimilar-iprs-timing-is-everything-but-when-is-the-right-time/

Blockchain

Ripple Price Analysis: XRP Bulls Defend 100-Day MA but What’s Next?

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XRP/USD – Bulls Continue To Defend 100-day MA.

Key Support Levels: $0.875, $0.8282, $0.8.
Key Resistance Levels: $0.95, $1.0, $1.05.

XRP might be beneath the crucial $1 level but is doing well to hold the 100-day MA. The coin established the support at $0.875 (.618 Fib & 100-day MA) last week and rebounded from there to meet resistance at $1.

Since hitting $1, XRP has moved sideways inside a range between $1 and $0.875. In addition to this, XRP is also trading inside a descending wedge formation as the market poises itself for a potential upside break.

xrpusd-sep28-min
XRP/USD Daily Chart. Source: TradingView.

XRP-USD Short Term Price Prediction

Looking ahead, the first resistance lies at $0.95 (200-day MA). This is followed by $1.00, $1.05, and $1.10 (50-day MA).

On the other side, the first solid support lies at $0.875 (100-day MA & .618 Fib). This is followed by $0.8282 (2020 highs), $0.8 (downside 1.272 Fib Extension), and $0.71.

The daily RSI remains beneath the midline as weak bearish momentum controls the market.

XRP/BTC – XRP Holding Rising Trend Line Support

Key Support Levels: 2200 SAT, 2100 SAT, 2000 SAT.
Key Resistance Levels: 2300 SAT, 2370 SAT, 2460 SAT.

XRP has also struggled heavily against BTC in September. The coin fell from above 2600 SAT at the start of the month to reach the current 2200 SAT level.

Last week, the coin fell beneath 2200 SAT but established support at the 100-day MA at around 2100 SAT. A rising trend line also bolstered the support in this area, and XRP has remained above this trend line so far.

Now, XRP must break the current range between 2300 SAT and 2100 SAT to dictate the next market direction.

xrpbtc-sep28-min
XRP/BTC Daily Chart. Source: TradingView.

XRP-BTC Short Term Price Prediction

Looking ahead, the first resistance lies at 2300 SAT. This is followed by 2370 SAT (bearish .382 Fib & 50-day MA0, 2460 SAT (bearish .5 Fib), and 2560 SAT (bearish .618 Fib).

On the other side, the first support lies at the rising trend line (around 2200 SAT). This is followed by 2100 SAT (200-day MA & 100-day MA), 2000 SAT (.618 Fib), and 2000 SAT.

Again, the RSI is marginally beneath the midline, indicating weak bearish momentum.

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Disclaimer: Information found on CryptoPotato is those of writers quoted. It does not represent the opinions of CryptoPotato on whether to buy, sell, or hold any investments. You are advised to conduct your own research before making any investment decisions. Use provided information at your own risk. See Disclaimer for more information.

Cryptocurrency charts by TradingView.


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Source: https://cryptopotato.com/ripple-price-analysis-xrp-bulls-defend-100-day-ma-but-whats-next/

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Blockchain

Europe Now World’s Biggest Crypto Economy: Boasts Over $1T Worth of Transactions

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Central, Northern, and Western Europe (CNWE) has grown into the world’s largest cryptocurrency economy since July 2020. The region experienced a massive increase in trading activity since then– particularly in the DeFi space.

The European DeFi Boom

Data from Chainalysis shows that CNWE received over $1 trillion in cryptocurrency over the last year alone. This represents 25% of global trading activity. Furthermore, it is responsible for at least 25% of all crypto value received by other regions, including 34% of the value received in North America.

This makes the EU the most concentrated in the world in terms of cryptocurrency trading volume. This is partially due to increases in all forms of trading activity over the past year, coming mostly from institutional investors.

Large institutional transaction value grew from $1.4B in July 2020 to $46.3B in June 2021, coming to take up half of all CNWE trading activity. The most pronounced increases were seen on DeFi protocols, where over 80% of these large institutional transactions were sent in June.

The impact of DeFi is further established when ranking coins in terms of transaction activity in the region. Despite being the largest cryptocurrency by market cap, Bitcoin heavily trails Ethereum in transaction volume among large institutional investors. Additionally, DeFi protocols took up a majority share of funds received by cryptocurrency services in CNWE in June 2021.


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The Decline in Eastern Asia

CNWE has seen significant absolute increases in its crypto trading volume. However, its new place as the world’s largest trading hub is partly due to a sharp decline in market share held by Eastern Asia– the previous world leader.

In early 2019 the region held over 30% of global transaction volume. This figure has since fallen sharply to about 15% – less than CNWE, North America, and even Central and Southern Asia.

This may be related to China’s continued push to prevent and discourage crypto trading within its borders. China re-announced their ban on crypto trading in the country days ago, and have been moving to prevent all access to exchanges within the country.

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Source: https://cryptopotato.com/europe-now-worlds-biggest-crypto-economy-boasts-over-1t-worth-of-transactions/

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Blockchain

Axie Infinity Records Holders ATH: 420% Year to Date Growth

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Popular non-fungible token (NFT) gaming platform Axie Infinity continues to see increased adoption from users, following exponential growth in the number of wallet addresses.

Axie Sees Surge in Address Holders

According to data provided by IntoTheBlock on Tuesday (September 28, 2021), Axie Infinity Shards (AXS) ownership is on the rise, with 17,480 address holders. This figure represents a new all-time high (ATH) and a 420% increase year-to-date (YTD). Meanwhile, this growth is indicative of the rising popularity of Axie Infinity and play-to-earn non-fungible token (NFT) gaming.

Back in July, CryptoPotato reported that the value of the AXS token skyrocketed nearly 400% within one month, leading to a market capitalization of over the $1 billion mark. Later in August, AXS was among the assets listed on the major cryptocurrency exchange Coinbase Pro, which also gave it an immediate boost.

Axis Infinity, developed by Sky Mavis and released in 2018, arguably popularised the play-to-earn trend and has recorded a number of impressive milestones in recent times. Data from DappRadar revealed that the project recorded over $2 billion in NFT sales volume, solidifying Axie’s place as the most valuable NFT collection, thereby surpassing major names such as CryptoPunks, Art Blocks, and NBA Top Shot.

The data also showed that more than 600,000 users traded Axis Infinity NFTs, resulting in 4,887,645 transactions. The project currently boasts over 1.5 million daily active users.


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According to Jeff Zirlin, co-founder of Axie Infinity, half of the platform’s users got to interact with cryptocurrency and blockchain for the first time through Axie, while 25% of them did not own a bank account.

The Growth of NFT Gaming

The NFT industry is becoming popular with celebrities, major sports leagues, and companies buying digital art in whatever form, or selling them. However, blockchain-based games are seeing a special kind of attention.

A report by DeFiPrime stated that the NFT Gaming market has a total market valuation of nearly $180 billion as of August 2021, with the value estimated to rise to $196 billion. An excerpt from the report reads:

“NFT games may have the potential to become the standard for the gaming market if it sees enough attention and popularity. Already they have made major changes to games and made it much more fun for players. From there, it could be a very major change to the way people play games and could be as major as Doom was to the market or 3D was for environments.”

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Source: https://cryptopotato.com/axie-infinity-records-holders-ath-420-year-to-date-growth/

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