分類彙整:產業訊息

聯生藥單株抗體新藥 UB-221 獲美國 FDA 核准 在慢性自發性蕁麻疹患者進行臨床一期試驗

聯合生物製藥(股)公司(聯生藥)今日宣布,其新型抗IgE單株抗體藥物 UB-221 已獲得美國FDA 核准在標準一線藥物H1 抗組織胺治療無效的慢性自發性蕁麻疹(Chronic Spontaneous Urticaria,CSU) 病患進行臨床一期試驗。慢性蕁麻疹的患病率約為1.8%。慢性自發性蕁麻疹發生率則約0.5〜1%。三分之二的慢性蕁麻疹是自發性的, 20至40歲之間是發病高峰期。 繼續閱讀

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United BioPharma Receives US FDA Approval for UB-221 Phase 1 IND for Chronic Spontaneous Urticaria

Taipei, Taiwan, November 8th , 2019 — United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from the U.S. FDA to conduct a phase 1 clinical trial with a novel anti-IgE monoclonal antibody UB-221, in patients suffering from chronic spontaneous urticaria (CSU) that is not adequately controlled by standard first-line H1-antihistamine treatments. The lifetime prevalence of chronic urticaria is approximately 1.8%. Chronic spontaneous urticaria occurs in 0.5~1% of the population at any point in time. Two out of three cases of chronic urticaria are spontaneous, with its incidence peaking between 20 and 40 years of age . 繼續閱讀

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Biogen’s good news on aducanumab could ‘open the floodgates’ for Alzheimer’s drugs

One of the many things I’ve learned during four decades of doing research on Alzheimer’s disease is that the work always brings surprises. Biogen’s announcement on Tuesday about its experimental Alzheimer’s drug, aducanumab, was a big one. 繼續閱讀

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愛滋病「每日用藥」治療模式,可能因一篇台灣研究而改變

從愛滋病被發現至今,其治療方式亦與時俱進。現在,患者能透過服用數十種藥物結合的複合劑來控制病毒,以防人體免疫系統受到嚴重損害,進而導致更嚴重、往往致命的後果。

但要控制愛滋病需要時時保持警戒。只要少服用幾劑藥物就可能給予病毒產生抗藥性的機會,並使這樣的新病毒大量複製而充斥全身。

在一篇發表於《新英格蘭醫學雜誌》(New England Journal of Medicine)的研究中,來自台灣聯合生物製藥公司(United BioPharma)的研究人員傳來令人振奮的消息。他們發現似乎僅需要定期注射藥物,就能成功阻斷愛滋病毒,同時改變當前每天都得服用的用藥模式。連同此研究結果在內,已有越來越多研究認為愛滋患者或許能在不危及健康的情況下,在緊湊的服藥過程中喘口氣。 繼續閱讀

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英國著名PharmaBoardRoom媒體記者、訪問聯生藥董事長暨科學長 王長怡博士

聯合生物醫學集團 (UBI)是一致力於發現、開發和商業化用於慢性和感染性疾病的免疫治療藥品和疫苗,並熱衷於以平台技術提供科學驅動創新的公司。王長怡乃UBI旗下子公司之一的聯合生物製藥(United BioPharma,UBP)董事長兼首席科學長,而UBP正是她所創立的UBI集團的其中一企業。她談論了她令人驚豔的事業生涯,包括從1973年身為首位被美國洛克菲勒大學錄取的亞洲女性博士生,到有機緣受數位諾貝爾獎得主指導或與共事而被薰陶訓練,以及她如何利用研究和管理經驗在年輕時即創立UBI公司,及她在重要領域中堅持在公司內部建立自主生產技術背後的思維。 繼續閱讀

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A vaccine for Alzheimer’s is on the verge of becoming a reality

For decades, research into Alzheimer’s has made slow progress, but now a mother and daughter team think they have finally found a solution – a vaccine that could inoculate potential 繼續閱讀

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Is an Alzheimer’s Cure on the Horizon?

By the time I was old enough to ask my grandmother questions about her life, it was too late. All I had were skeletons of stories I heard from my mom. I knew that it had been difficult for my grandmother when her parents, Irish immigrants on the vaudeville circuit, left her behind to help care for her younger brother when they traveled. But who cared for her? I heard about how, after her parents became successful radio stars, she was once set up on a date with Frank Sinatra, but when he arrived, with my grandmother waiting to make an entrance, he used language she didn’t like, so she sent word that she wouldn’t be going. But what had he said? I knew that she and my grandfather divorced not long after my mom was born, and that my grandmother subsequently spent time in the hospital. But for what illness? When I’d ask her, she’d respond about the weather. And maybe this was because she didn’t want to talk about it. Or maybe she didn’t remember. For years, her body was well but her mind was dying. It was like watching the electric grid of a city shut off one neighborhood at a time, until almost every street was dark. 繼續閱讀

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聯生藥治療單純皰疹病毒抗體新藥UB-621獲美國FDA核准 執行臨床2期復發型生殖器皰疹試驗

聯合生物製藥(股)公司(聯生藥)今日宣布,抗皰疹病毒單株抗體藥物UB-621已獲得美國FDA批准在由HSV-2感染所引起之復發型生殖器皰疹 (Recurrent Genital)患者族群上進行臨床第2期試驗: “A Phase 2 Trial to Evaluate the Safety and Efficacy of UB-621 in Adults with Recurrent Genital HSV-2 Infection”。UB-621可透過和病毒(HSV-1和HSV-2) 外表包膜上gD 蛋白之靶點作高親和力結合的機制1,阻止病毒侵入宿主而抑制感染。 繼續閱讀

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United BioPharma Receives US FDA Approval for UB-621 Phase 2 Trial in Recurrent Genital Herpes Patients

Taipei, Taiwan, June 10th , 2019 — United BioPharma (UBP) announced the receipt of Investigational New Drug (IND) approval from the U.S. FDA to conduct a phase 2 clinical trial with UB-621 monoclonal antibody for recurrent genital infection caused by Herpes Simplex Virus, type II (HSV-2). UB-621 works to inhibit the infection through high-affinity binding to the same epitope on viral surface envelope gD protein on both type I (HSV-1) and type II (HSV-2) viruses.1 繼續閱讀

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聯生藥治療愛滋病抗體新藥UB-421獲美國FDA 核准執行 多重抗藥性臨床試驗

聯合生物製藥(股)公司(聯生藥)今日宣布,美國FDA已同意其治療愛滋病抗體新藥UB-421在產生多重抗藥性之HIV-1感染者身上的臨床試驗: “A Multicenter, Single-Arm, 24-Week Study of UB-421 in Combination with Optimized Background Therapy (OBT) Regimen in Patients with Multi-Drug Resistant (MDR) HIV-1 Infection”。 繼續閱讀

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United Biopharma obtains approval from the U.S. FDA to conduct a clinical trial with UB-421 in Patients with Multi-Drug Resistance HIV-1 infection

Taipei, Taiwan, May 21, 2019 — United BioPharma (UBP) announced today that the company has obtained U,S. FDA’s permission to conduct a clinical trial with UB-421 in the USA, under the protocol entitled “A Multicenter, Single-Arm, 24-Week Study of UB-421 in Combination with Optimized Background Therapy (OBT) Regimen in Patients with Multi-Drug Resistant (MDR) HIV-1 Infection.” 繼續閱讀

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聯生藥治療愛滋病抗體新藥UB-421獲中國國家藥品監督管理局 核准多國多中心臨床3期試驗

聯合生物製藥(股)公司(聯生藥)今日宣布,其治療愛滋病單株抗體新藥UB-421規劃在台灣、泰國與中國三個地區執行之多國多中心臨床3期試驗,已於5月10日獲中國國家藥品監督管理局(National Medical Products Administration, NMPA)核准執行。此臨床試驗計劃先前已分別獲台灣衛生福利部食品藥物管理署 (TFDA)與泰國食品藥品管理局(Thailand FDA) 核准。 繼續閱讀

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United BioPharma Receives China NMPA Approval for UB-421 Phase 3 ART-Substitution Trial in HIV-infected Patients

Taipei, Taiwan, May 13, 2019 — United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) to conduct a multi-nation, multi-center phase 3 clinical trial with UB-421 substitution monotherapy for HIV-infected adults who are on a stable treatment course of antiretroviral therapy (ART). The INDs of this trial had been approved earlier by Taiwan and Thailand regulatory agencies. 繼續閱讀

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Effect of Anti-CD4 Antibody UB-421 on HIV-1 Rebound after Treatment Interruption(N Engl J Med 2019; 380:1535-1545)

Administration of a single broadly neutralizing human immunodeficiency virus (HIV)–specific antibody to HIV-infected persons leads to the development of antibody-resistant virus in the absence of antiretroviral therapy (ART). It is possible that monotherapy with UB-421, an antibody that blocks the virus-binding site on human CD4+ T cells, could induce sustained virologic suppression without induction of resistance in HIV-infected persons after analytic treatment interruption. 繼續閱讀

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美國時代雜誌對新英格蘭醫學期刊4月18日週刊發表之聯生藥UB-421突破性愛滋病臨床試驗結果相關報導

HIV treatment has come a long way since the early days of the epidemic. Patients can now take various combinations of dozens of medications keep the virus under control and halt their disease from decimating their immune systems and leading to more serious, often fatal outcomes.

But harnessing HIV requires daily vigilance. Missing doses of the pills can give the virus the chance to develop resistance to the drugs and lead to a surge in new copies of HIV that flood the body.

In a new study published in the New England Journal of Medicine, researchers at Taiwan-based United BioPharma report encouraging results with a single injection that seems to stymie HIV as well as daily pill regimens. The results add to a growing number of studies suggesting that patients may be able to take pill holidays without putting their health at risk. 繼續閱讀

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