药品创新断层

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Time of issue:2017-09-01 13:39
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(Summary description)随着近几年来美国和欧洲的药品审批数量稳步下降，药品生产翻开了新的一页。过去的几年出现了所谓的“药品创新断层”，也就是大量专利药的专利过期，与此同时也有大量新的、极有希望的候选药品正在排队。　　美国食品药品管理局FDA的“突破性治疗审批”程序在新药的快速认证审核过程中有着非常重要的意义，但也受到其他多种重要因素的限制，对制药生产设备有着直接的或间接的影响。　　在制药生产领域有着100多年重要意义的大

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药品创新断层

Categories:最新消息
Author:
Origin:
Time of issue:2017-09-01 13:39
Views:

Information

　　随着近几年来美国和欧洲的药品审批数量稳步下降，药品生产翻开了新的一页。过去的几年出现了所谓的“药品创新断层”，也就是大量专利药的专利过期，与此同时也有大量新的、极有希望的候选药品正在排队。

　　美国食品药品管理局FDA的“突破性治疗审批”程序在新药的快速认证审核过程中有着非常重要的意义，但也受到其他多种重要因素的限制，对制药生产设备有着直接的或间接的影响。

　　在制药生产领域有着100多年重要意义的大量专利过期之时，也是“大片时代”的终结。这一时代结束的原因之一就是投资者认为的、使制药领域的未来蒙上了不稳定的因素，分析家们提出了警告语“药品创新断层”。人们以每年的新药审批登记和新药研发储备的数量为依据认为制药业已出现危机。十几年来，制药企业在药品研发中投入了大量的金钱，然而审批许可的新药数量始终停滞不前，甚至还部分出现了倒退——研发部门的工作却比其他所有部门更为繁重。这带来了成本费用的大爆炸。

　　近年来，通过审核认证新药数量开始增加，市场上也有了新的、能够更好的医治原来难以医治或者根本无法医治疾病的药品了，而且审批通过的生物制剂的数量也在继续的增长。

　　也许FDA“突破性治疗审批”程序将是决定今后十年的一个转折点，尽管还不能非常肯定这种突破性治疗程序会在多长时间内发挥效益，但目前具有新的、创新性治疗作用的新药会比原来更快地通过审批。这对于数百万计的患者来讲自然是一件好事，但对于制药业内的所有企业来讲却是一个巨大的挑战。在经历了漫长的药品研发、药效验证和成本控制后，上市时间再次成为药厂口中的关键词。如何实现在最短的时间内上市，不仅仅面对的是研发过程的种种困难，生产设备的更新换代，以便能够适应未来的药品生产需要，还有专利布局以及市场的前期铺垫等等众多因素。

　　https://news.pharmacodia.com/web/newinfo/information_8a2d98375df8dd3e015e137cd68c04fc.html

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Electronic Arts pledges free use for five accessibility patents

Electronic Arts pledges free use for five accessibility patents Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The code of the mentioned technology is published on EA’s GitHub, and it is open to all developers. Thus, the developers can use it or adapt it for their games without spending the costs to research. It is good that EA shares the patents for free use and aims to create an accessibility-increased gaming environment for players. However, it is not “unconditional” to use the listed patents. In the pledge, EA mentioned that it may terminate the promise for a specific party which files a patent infringement lawsuit or other patent proceedings against EA. We can see parts of EV’s ambition behind the announcement—to build a large game developer league and a community of shared interests. Reference: https://www.ea.com/commitments/positive-play/accessibility-patent-pledge https://iknow.stpi.narl.org.tw/Post/Read.aspx?PostID=14562 https://www.polygon.com/22639469/apex-legends-electronic-arts-patent-pledge-accessibility-developers https://www.theverge.com/2021/8/24/22638535/ea-accessibility-patent-pledge-apex-legends-ping-system https://www.gamesradar.com/ea-secures-a-patent-for-the-apex-legends-ping-system-and-its-giving-it-away-for-free/ https://dotesports.com/apex-legends/news/apex-legends-ping-system-is-now-patent-free-for-accessibility https://www.nintendolife.com/news/2021/08/apex_legends_ping_system_now_patent-free_as_ea_announces_accessibility_pledge Recently, Electronic Arts (EA) announced a patent pledge that gives other companies and developers free access to five of its current accessibility-related patents and technology. The company promised not to enforce against any party for infringing any of the listed patents. Instead, EA hopes to encourage “innovation” and build new features that make video games more inclusive on a much larger scale by opening up the patents. Electronic Arts (EA) is an American video game company founded in 1982. The company owns many popular and famous games, such as The Sims, SimCity, Apex Legends, Madden NFL and FIFA. Each of the games has more than 30 or 50 million sales volume. Significantly, esports involves FIFA and Apex Legends into the event list. Apex Legends has up to 1 billion players, and it is so popular that it has a Switch version. Within the freely available patents, one of which grabs everyone’s attention -- Apex Legends’ ping system (patent No. US 11097189). The ping system in Apex Legends, which excellently allows players to make communication and teamwork quick and easy without hearing or speaking, has been praised both as an impressive alternative to voice chat and as a great accessibility feature for players with a variety of disabilities. The other patents include the technology widely used in the FIFA and Madden NFL. The innovations can automatically detect and modify colors (patent No. US 10118097 and CN 107694092) and contrast ratios (patent No. US 10878540) to improve gamers’ visibility with colorblindness and low vision. Furthermore, one of the patents relates to personalized sound technology, helping players with hearing issues by modifying or creating music based on their preferences (patent No. US 10790919). The

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