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中国的临床研究机会和美国食品药品监督管理局批准的途径 – 白皮书

tallulah
1 minute

SYDNEY, AU, Oct 26, 2022 - (亚太商讯 via SEAPRWire.com) - Novotech、亚太地区领先的生物技术专家合同研究机构和GlobalData发布了最新的中国生物技术前景分析，并就美国 FDA 批准在中国开展研究的生物技术的途径提供专家指导。点击这里下载白皮书 https://novotech-cro.com/whitepapers/china-biotech-landscape-opportunities-china-and-path-usfda-approval该报告是为考虑在中国进行临床研究的国际生物技术公司以及在中国进行研究的中国生物技术公司以及美国FDA批准所需的相关流程编写的。Novotech 副总裁、临床服务全球负责人 Yooni Kim 博士说：“中国拥有庞大的人口和世界级的研究设施和 KOL，提供了非凡的临床机会。这份对美国FDA批准途径的简明分析专业地告知临床阶段的生物技术公司有关中国研究的好处以及如何应对任何挑战。该报告详细介绍了生物技术的监管要求，包括NDA和IND流程，以及成功获得USFDA批准途径的美国前研究指南。Novotech 在中国和美国拥有经验丰富的临床团队，可以提供相关的监管知识和药物开发途径，专门为支持美国 FDA 的审批流程而设计，避免延误和额外成本。”该报告的主要收获是：- 公司应尽早与美国食品和药物管理局正式接触，以确认其临床路线图的指导。- 中国的临床开发法规与美国食品药品监督管理局的法规一致，为生物制药公司带来了巨大的利益。- 生物制药公司应利用中国修订后的监管框架，即接受外国临床试验数据进行药物审批，使外国公司更容易进入中国市场。- 对于希望进入中国的生物制药公司而言，中国医药市场具有开展首次人体试验（FIH）和利用海外临床试验数据进行临床试验申请（CTA）备案、利用快速临床开发途径加快审批等优势。过程;上市许可持有人 (MAH) 制度的实施、促进国内和全球创新的有利政府政策鼓励外国直接投资 (FDI) 进行研发，使海外公司受益。- 中国生物技术公司可以通过战略合作或在这些市场建立自己的业务，进入美国和欧洲的发达市场。Novotech 在亚太地区和美国拥有丰富的临床研究机构运营经验，为早期至晚期生物技术临床研究提供独特且无与伦比的服务套件。Novotech 拥有数十年的生物技术药物开发经验、卓越的研究中心和研究人员关系、接触大量患者群体以及专注于解决问题、所有权和灵活性的项目管理方法。对高级培训和技术系统的持续投资相结合，提供专业的全方位服务生物技术临床研究机构解决方案。Novotech 最近被评为世界领先合同研究组织中的前十名合同研究组织，是著名的 Scrip 奖的决赛入围者，并且刚刚获得了基因与细胞治疗卓越奖。在亚太地区，Novotech 与主要医学研究机构签...

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生物技术领域网络研讨会：市场趋势、优先事项、预测和 FDA 批准途径

tallulah
1 minute

SYDNEY, AU, Oct 17, 2022 - (亚太商讯 via SEAPRWire.com) - Novotech 是亚太地区领先的生物技术专家合同研究机构和 Endpoints News 为生物技术公司举办的网络研讨会，涵盖了亚太地区的临床研究机会和获得 FDA 批准的监管途径。Novotech 在亚太地区和美国拥有丰富的临床研究机构运营经验，为早期至晚期生物技术临床研究提供独特且无与伦比的服务套件。该网络研讨会邀请了来自北美和亚太地区的监管事务和投资领导人，他们将讨论：- 为什么生物技术公司越来越多地在亚太地区探索临床机会以生成多样化、全球认可的临床试验数据- 可以实施哪些可行的策略来利用亚太地区的招聘潜力来加速您的临床开发- 来自澳大利亚的 1 期数据如何被 FDA 接受并可以用于启动全球药物开发计划- 深入洞察设计和提供强大临床计划的过程- 后COVID环境中的生物技术挑战和机遇，重点是全球投资和药物管道注册网络研讨会 这里 https://webinars.endpts.com/the-biotech-landscape-market-trends-priorities-predictions-and-pathways-to-fda-approval/2022 年 10 月 18 日美国东部时间下午 1:00 - 下午 2:00出席的行业领导者包括：- 联生生物首席财务官易拉森。曾任 Turning Point Therapeutics, Inc. 和 Goldman Sachs & Co. LLC 执行副总裁兼首席财务官，医疗投资银行业务董事总经理- Kasey Kime，Novotech 内部咨询集团 BioDesk 的法规事务总监- Jeanne M. Novak 博士，CBR International Corp. 总裁兼首席执行官，该公司是一家提供全方位服务的产品、临床和监管战略集团- Monograph Capital Partners 的联合创始人兼董事长 Fred Cohen 博士。他还是 Vida Ventures 的联合创始人和高级董事总经理。Novotech 拥有数十年的生物技术药物开发经验、卓越的研究中心和研究人员关系、接触大量患者群体以及专注于解决问题、所有权和灵活性的项目管理方法。对高级培训和技术系统的持续投资相结合，提供专业的全方位服务生物技术临床研究机构解决方案。Novotech 最近被评为世界领先合同研究组织中的前十名合同研究组织，是著名的 Scrip 奖的决赛入围者，并且刚刚获得了基因与细胞治疗卓越奖。在亚太地区，Novotech 与主要医学研究机构签订了 50 多项领先的合作伙伴协议，为赞助商提供独家优惠。关于Novotech健康控股Novotech健康控股有限公司（“Novotech”）是亚...

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Qantas sees return to 100% of pre-pandemic domestic capacity by January

elean
2 minutes

SYDNEY (REUTERS) - Qantas Airways expects to get back to flying 100 per cent of its pre-pandemic domestic capacity by January as Australian state borders open up due to surging Covid-19 vaccination rates, the airline's chief executive said on Thursday (Oct 21). "It looks like by Christmas, we will have every state open except for Western Australia, and Western Australia will open up domestically, hopefully, early in the new year; we assume around February," Qantas CEO Alan Joyce said at an industry conference held by Flight Centre Travel Group. Travel restrictions between Sydney and Melbourne, Australia's largest cities, eased on Wednesday as Victoria opened its borders to fully vaccinated residents from New South Wales amid a rapid rise in immunisation levels. With cases trending lower in New South Wales, including Sydney, residents will be allowed quarantine-free entry into Victoria for the first time in more than three months. Travellers from Melbourne who wish to enter Sydney, however, must undergo a two-week home quarantine. Mr Joyce said Qantas had just one daily flight from Sydney to Melbourne at present, down from 55 before the Covid-19 pandemic when it was one of the world...

SeaPRwire

Sydney Airport gets $22.3 billion takeover bid

elean
2 minutes

SYDNEY (BLOOMBERG) - Sydney Airport received a A$22.3 billion (S$22.3 billion) takeover offer from a group including IFM Investors, in one of the boldest bets since the pandemic on a recovery of global travel. The consortium offered A$8.25 a share, Sydney Airport said in a statement Monday. It said it's assessing the proposal, which is 42 per cent higher than Friday's closing price of A$5.81. The stock traded close to A$9 in late 2019, before Covid-19 devastated aviation. The suitors are seeking to capitalise on the slump in market value at Australia's largest airport, which is also the country's main overseas gateway, before global travel starts to pick up. Australia's international border, which as been mostly closed since March last year, is expected to open in mid-2022 after the nation's vaccination program is completed. Sydney Airport said it's considering "whether the proposal is reflective of the underlying value of the airport given its long-term remaining concession and the expected short-term impact of the pandemic." Sydney Airport named Barrenjoey Capital Partners and UBS Group AG as financial advisers. One of the conditions of the offer is that UniSuper Ltd., which owns...

SeaPRwire

Sydney firm bucks hybrid work trend, adds more space and piano to get staff back

elean
3 minutes

(BLOOMBERG) - It is literally music to the bosses' ears. Canadian investment giant Brookfield Asset Management is bucking the hybrid work trend by introducing a slew of creative measures, including putting a grand piano in the office lobby for executives to have a go at it. In the Asia-Pacific headquarters of the world's second biggest office landlord in Sydney, 90 per cent of staff have been coming in for close to a year, according to Ms Sophie Fallman, managing partner and head of Australia real estate. And she's betting that office life isn't dying any time soon, echoing sentiments of Brookfield chief executive officer Bruce Flatt, who has said he's planning to add to his US$210 billion (S$283 billion) real estate portfolio. "We are an office-based culture, it's best when we are together," Ms Fallman said in an interview. "It's a value known and understood throughout our firm. That doesn't mean people don't realise that everyone has a life outside the firm, we're all adults about it." It is a very different scenario from many workplaces globally and even in Australia, where strict early lockdowns have kept the virus at bay while allowing for the opening of most big cities. Wall ...

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The third TDMall in the world opened in Sydney, Australia

indie
4 minutes

HONG KONG, Mar 16, 2021 - (ACN Newswire via SEAPRWire.com) - TDMall (Group) Limited, a subsidiary of Tianda Pharmaceuticals Limited (listed on the main board of the Hong Kong Stock Exchange: 00455) has invested in the establishment of modern-style Chinese medicine clinic - TDMall, and grandly opened its third TDMall in the world, TDMall (Sydney), on 14 March in Macquarie Park, Sydney, Australia. TDMall is committed to bringing the unique benefits Chinese medicine to the people in Sydney's communities, in New South Wales and all over Australia by providing premium, accessible and comprehensive Chinese medicine health services, in order to fulfill its mission of helping people in different parts of the world with Chinese medicine! Officiating guests at the ribbon-cutting ceremony, including Mr. John Alexander OAM, MP, Member for Bennelong, New South Wales(first left), Mr. Zhou Guangming, the Australian Chinese community celebrity (second left), Mr. Simon Zhou, City of Ryde Councilor (third left).TDMall (Sydney)'s registered Chinese medicine practitioners give diagnosis to every individual in the free consultation activity to last until end of April.A number of distinguished guests at...

SeaPRwire

Sydney housing boom lifts prices to all-time high

elean
1 minute

SYDNEY (BLOOMBERG) - Housing prices in Sydney soared to an all-time high, gaining 5.7 per cent since last year's low in October as the economy continues to recover. Sydney property values are now higher than the prior peak in 2017, CoreLogic data released on Thursday (March 11) showed. However, Melbourne remains 1.3 per cent below its pre-pandemic high and Perth is almost 17 per cent below the top of 2014. "The fresh record high is great news for Sydney home owners, but highlights the challenges for non-home owners looking to participate in the housing market as values rise faster than incomes," said Tim Lawless, CoreLogic's executive research director. The rapid gains have been fueled by record-low borrowing rates, an improving economic outlook, an under-supply of listings and government incentives. While house prices are also surging from Singapore to Canada and the US, a return to boom times in Australia threatens to swell an already worrisome pile of household debt and make it harder for young people to buy their first property. More on this topic Related Story Australia home prices surge at fastest pace since 2003 in February Related Story Property prices in Australia surge to...

SeaPRwire

Australian casino faces probe over money laundering

elean
2 minutes

SYDNEY • Crown Resorts' stock yesterday slumped the most since March after the casino operator said it is being investigated for possible breach of anti-money laundering and counter-terrorism financing rules. Australia's financial crimes regulator has started an enforcement probe into compliance at Crown's flagship Melbourne casino, the company said. Austrac's concerns arose during an assessment that started in September last year and focused on how the casino handled individuals deemed to be high-risk and politically exposed. It is not clear who those people were, but Crown has courted wealthy Asians as part of its programmes for high-stakes gamblers. With Crown's annual meeting set for Thursday, the probe piles pressure on a company already beset by governance failures. A separate inquiry in Sydney has unearthed lapses in anti-money laundering controls and there are growing calls from investors for a board shake-up and more independence from billionaire shareholder James Packer. Crown shares sank 8.23 per cent to close at A$8.25 in Sydney trading. That extended the year's slump to 32 per cent. Crown said it will fully cooperate with Austrac and respond to all information requests...