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Today, a brief rundown of news involving Valneva and Jazz Pharmaceuticals, as well as updates from Ultragenyx Pharmaceutical, Nuclidium and Pharvaris that you may have missed.
今天,简要介绍您可能错过的有关Valneva和Jazz Pharmaceuticals的新闻,以及Ultragenyx Pharmaceutical、Nuclidium和Pharvaris的最新动态。
The
The
European Medicines Agency
欧洲药品管理局
on Friday
在周五
lifted its order
解除了命令
to pause use of
暂停使用
Valneva’s
瓦尔内瓦的
chikungunya vaccine in people aged 65 years and older. The decision to remove the restriction followed a review by the regulator’s safety committee, which concluded the shot, called
65岁及以上人群的基孔肯雅热疫苗。取消限制的决定是在监管机构的安全委员会进行审查后作出的,该委员会得出结论认为该疫苗被称为
Ixchiq
伊奇基克
, should only be given to people of any age if there “is a significant risk of chikungunya infection and after a careful consideration of the benefits and risks.” The EMA had limited the shot’s availability in May after
“只有在存在显著的基孔肯雅病毒感染风险,并且在仔细权衡益处和风险后,才能给任何年龄的人接种。”欧洲药品管理局(EMA)在五月份限制了该疫苗的可用性,原因是
17 severe adverse events were reported
报告了17起严重不良事件
, including two deaths. The
,包括两例死亡。
Food and Drug Administration
食品药品监督管理局
also temporarily
也暂时
suspended
暂停
use of the vaccine in people at least 60 years of age.—
用于至少60岁的人群的疫苗。—
Delilah Alvarado
德尔ilah 阿尔瓦拉多
Jazz Pharmaceuticals
爵士制药公司
on Thursday
在周四
named
命名
Renee Gala
雷内·加拉
, a former Grail and Theravance Biopharma executive who joined Jazz in 2020, as the company’s successor to
,这位曾在2020年加入Jazz的前Grail和Theravance生物制药高管,被任命为该公司的继任者,
retiring CEO
退休的首席执行官
Bruce Cozadd
布鲁斯·科扎德
. Gala’s promotion to CEO, from her current role as president and chief operating officer, will take effect next month. Jazz’s board of directors considered both internal and external candidates, lead independent director
加拉将从她目前的总裁兼首席运营官职位升任为首席执行官,这一任命将在下个月生效。爵士董事会考虑了内部和外部候选人,独立董事牵头。
Rick Winningham
里克·温宁汉姆
said in a statement. “Among a field of highly capable and qualified candidates, Renee was the clear standout,” he added. Cozadd co-founded Jazz more than two decades ago and has led it through a
在一份声明中表示。“在众多能力出众、资历优秀的候选人中,雷内显然脱颖而出,”他补充道。科扎德于二十多年前共同创立了爵士制药,并带领公司经历了一段...
$7 billion acquisition
70亿美元的收购
, a
,一个
corporate tax inversion
公司税负倒置
and the approval of several medicines. —
以及几种药物的批准。——
Ned Pagliarulo
内德·帕利亚鲁洛
A closely watched clinical trial testing a drug from
一项备受关注的临床试验测试一种药物
Ultragenyx Pharmaceutical
Ultragenyx制药公司
and
和
Mereo BioPharma
梅雷奥生物制药
will continue past a second interim analysis, disappointing both the companies and their investors, who had hoped the study would hit its goal early. The drug, called
将继续进行第二次中期分析,这让公司和投资者感到失望,他们原本希望研究能早日达到目标。这种药物叫做
setrusumab
塞妥珠单抗
, is being tested in children and young adults with osteogenesis imperfecta, a cluster of genetic disorders that tend to increase bone brittleness and cause frequent fractures. Shares in both companies fell this week after
,正在患有成骨不全症的儿童和年轻人中进行测试,成骨不全症是一组遗传性疾病,往往会增加骨骼脆弱性并导致频繁骨折。两家公司的股票都在本周下跌了。
they said Wednesday
他们星期三说
that a Phase 3 study called
名为3期的研究
Orbit
轨道
would continue on to a final analysis after data monitors reviewed preliminary data. —
将在数据监控人员审查初步数据后继续进行最终分析。
Ned Pagliarulo
内德·帕利亚鲁洛
Radiopharmaceutical developer
放射性药物开发商
Nuclidium
核素
announced Thursday
周四宣布
it has raised 79 million Swiss francs, or about $99 million, in venture financing to support its advancement into the clinic. The Series B round, which was co-led by Angelini Ventures, Kurma Growth Opportunities Fund, Wellington Partners and Neva SGR, will be used to develop both medicines and diagnostics, as well as expand its manufacturing.
它已经筹集了7900万瑞士法郎(约合9900万美元)的风险融资,以支持其进入临床阶段。这笔B轮融资由Angelini Ventures、Kurma Growth Opportunities Fund、Wellington Partners和Neva SGR共同领投,将用于开发药物和诊断技术,并扩大其生产能力。
Nuclidium says it’s testing its experimental copper isotopes in breast and prostate cancers, as well as neuroendocrine tumors..
Nuclidium 表示,它正在乳腺癌、前列腺癌以及神经内分泌肿瘤中测试其试验性的铜同位素。
—
—
Gwendolyn Wu
吴瑰琳
Pharvaris
法瓦里斯
expects to report the first Phase 3 results for its experimental hereditary angioedema therapy later this year, instead of in 2026 as originally anticipated, the company said Thursday. Pharvaris’ drug,
公司周四表示,预计将在今年晚些时候报告其用于遗传性血管性水肿的实验性疗法的首个第三阶段结果,而不是最初预期的2026年。Pharvaris的药物,
deucrictibant
德乌克里克提班特
, is an oral therapy being tested as a way to either
,是一种正在测试中的口服疗法,作为一种要么
prevent the disease’s hallmark swelling attacks or quickly treat the symptoms
预防该疾病的标志性肿胀发作或快速治疗症状
associated with them. Results from a late-stage study evaluating it as an on-demand treatment are coming first and, if positive, could position the company to challenge
与它们相关。评估其作为按需治疗的后期研究结果将首先出炉,如果结果积极,可能使该公司有能力挑战
Kalvista Pharmaceuticals
卡尔维斯塔制药公司
’ recently approved
’最近获批
Ekterly
埃克特利
. Pharvaris expects to file an approval application in the first half of next year, should the study succeed.
Pharvaris 预计在明年上半年提交批准申请,前提是研究取得成功。
—
—
Ben Fidler
本·菲德勒