Daiichi Sankyo made changes to its top ranks as it accelerates development of new molecules through the pipeline. A Fosun Pharma subsidiary won a green light for its Rituxan copycat in China, and it's the country's first approved biosimilar. Nasdaq-listed Chinese vaccine maker Sinovac has activated a “poison pill” takeover defense against a group of shareholders that together own 40% of the company. And more.
1. Doubling down on R&D, Daiichi makes executive changes across its U.S. research unit
Daiichi Sankyo is promoting Junichi Koga, Ph.D., to lead global R&D at the company’s U.S. site in New Jersey. Ken Keller, who’s been overseeing commercial operations, has been named as president and CEO of Daiichi’s U.S. division. Keller will “focus on forging even stronger collaboration between R&D and commercial efforts,” the company says. Both Koga’s and Keller’s new titles have been held by Glenn Gormley, M.D., Ph.D., who will become chairman of the U.S. affiliate.
2. China approves its first biosimilar, a Rituxan copy from Fosun’s IPO-heading Henlius
Chinese authorities have approved the country’s first biosimilar, a copy of Roche’s Rituxan made by Fosun Pharma’s joint venture subsidiary Shanghai Henlius Biotech. Rituxan amassed about 1.73 billion yuan ($258.6 million) in China sales in 2017, according to Iqvia data cited by Fosun. The company is preparing to list the biologics unit on the Hong Kong Stock Exchange.
3. Sinovac swallows poison pill to fend off rebel investors' coup attempt
Sinovac is issuing new shares to dilute investor holdings so that some rebels can’t take control. It’s the first “poison pill” defense in more than a decade, Reuters reports. OrbiMed, 1Globe Capital, Chiangjia Li and others were identified as collaborators attempting a takeover. Together, those investors held 40% of Sinovac’s shares before the new issue.
4. U.S. generic drugs are safe and effective, FDA commissioner reiterates
FDA Commissioner Scott Gottlieb turned to Twitter to defend the quality of the U.S. generic drug supply, a large proportion of which comes from abroad. Gottlieb pointed out that FDA inspections of generic manufacturing facilities have increased, and the number of warning letters issued is up nearly fivefold. There were 24 warning letters sent to Chinese sites last year and 15 to sites in India.
5. Takeda gout drug Uloric loses first-line approval after FDA confirms death risks
After examining postmarketing data, the FDA decided Takeda’s gout drug Uloric carries an increased risk of death compared with the older drug allopurinol. The agency slapped a boxed warning on Uloric’s label and is limiting its use to the second-line setting—patients who have failed on or do not tolerate allopurinol.
6. Bispecifics player Abpro teams up with China’s NJCTTQ in biobucks deal worth up to $4B
Abpro is partnering with China’s NJCTTQ to develop new bispecific antibodies against unspecified targets. Abpro could collect up to $4 billion, which includes $60 million in near-term R&D funding. NJCTTQ could get Chinese rights for drugs that come out of the collaboration. Abpro in 2016 signed a $3.5 million deal with Chinese biotech Essex Bio to co-develop monoclonal antibodies.
7. Takeda, Microsoft rare disease partnership publishes diagnosis road map
Takeda doubled down on rare diseases with its Shire deal, and now it's teaming up with Microsoft and Eurodis to speed up rare disease diagnoses. The partners devised three pathways to making that happen: The first program uses machine learning to identify symptom patterns, the second focuses on “intelligent triage” and genetic consultations, and the third project is working to develop a secure rare disease patient registry.
8. Dr. Reddy's solid dose plant pinched by FDA for missteps
Shortly after Dr. Reddy’s reported that the FDA had issued a Form 483 for its formulations plant in Bachupally, India, the FDA posted another Form 483 for the Indian firm’s solid dose plant in Pradesh. Four violations were cited, including failure to investigate out-of-spec analysis when impurities were found.
9. FDA finds Aurobindo sterile drug plant continues to have problems
The FDA had found problems at an Aurobindo sterile manufacturing plant last year, and another inspection recently revealed some similar problems. In a 12-page Form 483 for the Unit IV facility in Pashamylaram, India, the agency again described some sanitation shortfalls. The plant has several pending drug applications before the FDA.
10. Thermo Fisher halting sequencer sales in western China following reports of DNA surveillance program
Thermo Fisher Scientific has halted sales of its DNA sequencing hardware in western China, following a series of reports that its products were being used in a state surveillance program aimed at ethnic minorities in the region, according to The Wall Street Journal.
11. PPD inks deal with China’s HLT to create data science-driven research solutions
PPD has inked a deal with China’s Happy Life Tech (HLT) to develop data science-driven drug R&D solutions for both global and Chinese biopharma companies. HLT will offer its AI and data tech and PPD its expertise in clinical trial management and evidence generation.
第一三共 (Daiichi Sankyo) 通过管道加速开发新分子，从而改变了公司的高层。复星医药旗下的一家子公司为其在中国的 Rituxan 仿制药赢得了绿灯，这是中国首个获批的生物仿制药。在纳斯达克上市的中国疫苗生产商——中信证券 (Sinovac) 发起了一场“毒丸”式的收购防御行动，以对付持有该公司 40% 股份的股东集团。以及更多。1. Daiichi 在研发方面加倍，在其美国研究部门 Daiichi Sankyo 进行管理层变更，正在推动 Junichi Koga 博士在公司位于新泽西州的美国地点领导全球研发。一直负责商业运营的肯恩凯勒 (Ken Keller) 已被任命为第一汽车美国分公司的总裁兼首席执行官。凯勒将“专注于在研发和商业努力之间建立更强大的合作关系，”该公司表示。Koga 和 Keller 的新头衔都由 Glenn Gormley（医学博士、哲学博士）持有，他将成为美国分公司的董事长。像这样的免费每日通讯？订阅 FiercePharma！生物制药是一个快速增长的世界，每天都有大的想法出现。我们的订户依赖 FiercePharma 作为他们的必读信息来源，获取关于药品及其生产商的最新消息、分析和数据。今天注册，以获得医药新闻和更新交付到您的收件箱和阅读走。现在订阅 2。中国批准其首个生物仿制药，这是来自复星 IPO 掌门人 Henlius 的 Rituxan 副本中国当局已经批准了该国首个生物仿制药，该生物仿制药是由复星医药合资子公司上海复宏汉霖生物技术公司生产的 Roche’s Rituxan 的副本。根据复星引用的 Iqvia 数据，2017 年 Rituxan 在中国的销售额累计约为 17.3 亿元人民币（合 2.586 亿美元）。公司正准备在香港交易所上市生物制剂部门。3. 华大基因吞服毒丸以抵御叛军投资者的政变企图华大基因正在发行新股以稀释投资者的持股，以至于一些叛军无法控制。据路透社报道，这是十多年来首个“毒丸”防御系统。OrbiMed、1Globe Capital、Chiangjia Li 等被认定为试图收购的合作者。在新股发行前，这些投资者总共持有 40% 的股份。4. 美国仿制药是安全有效的，FDA 专员重申 FDA 专员 Scott Gottlieb 转向 Twitter 为美国仿制药供应质量辩护，其中很大一部分来自国外。Gottlieb 指出，FDA 对仿制药生产设施的检查有所增加，发出的警告信数量增加了近 5 倍。去年有 24 封警告信发给中国网站，15 封发给印度网站。5. 武田痛风药 Uloric 失去一线批准在 FDA 审查上市后数据证实死亡风险后，FDA 决定武田的痛风药 Uloric 与老药别嘌呤醇相比，死亡风险增加。该机构在 Uloric 的标签上打了一个黑框警告，并将其限制用于二线治疗——别嘌呤醇治疗失败或不能耐受的患者。6. Bispecifics player Abpro 团队与中国的 NJCTTQ 在 biobucks 交易价值高达 4 亿美元 Abpro 正在与中国的 NJCTTQ 合作开发针对未指明靶点的新型双特异性抗体。Abpro 可以募集到高达 40 亿美元的资金，其中包括 6000 万美元的近期研发资金。NJCTTQ 可以获得来自合作的药物的中国权利。Abpro 在 2016 年与中国生物技术艾塞克斯生物签订了 350 万美元的交易，共同开发单克隆抗体。7. Takeda,Microsoft rare disease partnership 发布 diagnosis 路线图 Takeda 凭借其 Shire 交易在罕见病领域翻番，现在它正联手微软和 Eurodis 加快罕见病的诊断。合作伙伴设计了三条实现这一目标的途径：第一种方案利用机器学习来识别症状模式，第二种方案侧重于“智能分诊”和遗传咨询，第三种方案致力于开发安全的罕见病患者登记处。 8. Dr. Reddy’s solid dose plant 在 Dr.Reddy’s 的报道称，FDA 已经为其位于印度 Bachupally 的制剂工厂发布了一份表格 483，FDA 为这家印度公司位于 Pradesh 的固体剂量工厂发布了另一份表格 483。引用了 4 项违规事件，包括发现杂质时未能调查超标分析。9. FDA 发现 Aurobindo 无菌药厂继续存在问题 FDA 去年曾在一家 Aurobindo 无菌药厂发现问题，最近的另一次检查也发现了一些类似的问题。在一份长达 12 页的表格 483 中，该机构再次描述了印度 Pashamylaram 的第四单元设施的一些卫生缺陷。这家工厂在 FDA 面前有几个悬而未决的药物申请。10. Thermo Fisher halting 测序仪在中国西部的销售继报道 DNA 监控计划 Thermo Fisher Scientific 已经叫停了其 DNA 测序硬件在中国西部的销售，此前有一系列报道称，其产品被用于针对该地区少数民族的国家监控计划，据《华尔街日报》报道。11. PPD inks 与中国的 HLT 达成交易，创建数据科学驱动的研究解决方案 PPD 与中国的快乐生活科技 (HLT) 达成了交易，为全球和中国的生物制药公司开发数据科学驱动的药物研发解决方案。HLT 将向其 AI 和 data tech 以及 PPD 提供其在临床试验管理和证据生成方面的专业知识
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