雖然這篇drug@fda鄉民發文沒有被收入到精華區：在drug@fda這個話題中，我們另外找到其它相關的精選爆讚文章
在 drug@fda產品中有2篇Facebook貼文，粉絲數超過4萬的網紅立法委員葉毓蘭，也在其Facebook貼文中提到， #停止認知作戰了吧 #復必泰的英文名字是Comirnaty #還是Comirnaty的中文名字叫復必泰 今天傳來好消息，由台積電、永齡、慈濟與德國輝瑞原廠在7/12完成簽約，採購的一千五百劑的BNT疫苗，可望在郭董親自前往歐洲催貨搶貨後，在八月底前會有150萬至200萬劑抵台。 從的輝瑞疫苗，關...
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No Drug Name Approval Date 46 Cytalux 11/29/2021 45 Livtencity 11/23/2021 44 Voxzogo 11/19/2021
Approval Date Drug Name Submission Active Ingredients 12/01/2021 SINE‑AID IB; NDA #019899 SUPPL‑20 IBUPROFEN; PSEUDOEPHEDRI... 12/01/2021 CARBATROL; NDA #020712 SUPPL‑37 CARBAMAZEPINE 12/01/2021 EOVIST; NDA #022090 SUPPL‑19 GADOXETATE DISODIUM
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drug@fda 在 立法委員葉毓蘭 Facebook 的最佳貼文
#停止認知作戰了吧
#復必泰的英文名字是Comirnaty
#還是Comirnaty的中文名字叫復必泰
今天傳來好消息，由台積電、永齡、慈濟與德國輝瑞原廠在7/12完成簽約，採購的一千五百劑的BNT疫苗，可望在郭董親自前往歐洲催貨搶貨後，在八月底前會有150萬至200萬劑抵台。
從<聽到樓梯響，但一直沒有看到人下來>的輝瑞疫苗，關鍵在政府要求疫苗標籤不能出現復星、復必泰的中英文名稱，所以這些疫苗的標籤必須完全客製化，因此德國方面第一批疫苗出廠時程，是訂在九月十八日，最快可望在九月廿一日中秋節前到貨。
今天上午媒體記者來問了，郭董搶來的疫苗是其他國家讓給我們的，所以標籤來不及客製化，極有可能就是原來的「Comirnaty」疫苗。
其實所謂必須要【消滅】標籤上的復星、復必泰、Comirnaty字樣，從來就是一個假議題，而這個議題從去年臺灣東洋製藥要進口BNT疫苗開始，在綠媒、綠委、行政院官員的推波助瀾之下，成為認知作戰焦點，有不少國人已經被洗腦成功:斯斯有兩種，輝瑞也有兩種，居然相信復必泰就是即將過期、中國代工的疫苗，而Comirnaty就是劣質的復必泰!
其實，輝瑞BNT疫苗問世以來，就叫Comirnaty，不管你上歐盟醫藥署(European Medicines Agency)或美國食藥署(US Food & Drug, FDA)的網站，都明明白白告訴公眾， 這是Covid-19的mRNA疫苗，商標名稱(Tradename)就叫做Comirnaty.
這個名字也可以看出命名者的巧思與用心，把常用的Community (社群、社區)嵌入mRNA，藉以紀念這個重大的疫苗濟世救人成就與突破。
BNT疫苗(Comirnaty)能夠成為無比龜毛的美國FDA發給第一張完全合格的藥證，成為可以自由買賣的疫苗，是幾億接種民眾證實的保護力，這是科學證據，不要再汙名化，也不要有任何認知作戰了，儘快讓人民可以打到BNT吧!
#感謝郭董
#歡迎BNT早日來台保護臺灣
drug@fda 在 台灣光鹽生物科技學苑 Facebook 的最佳貼文
<生醫新聞>Cyclacel臨床三期的急性骨髓性白血病藥物在關鍵研究中失敗
#AcuteMyeloidLeukemia #FailedTrials #ClinicalResearch #Cyclacel #Decitabine #Sapacitabine #FDA
Cyclacel Pharmaceuticals has been taught the meaning of futility. Two years after an independent data monitoring board told Cyclacel its phase 3 acute myeloid leukemia (AML) trial was destined to fail, the ever-optimistic biotech has reported its drug sapacitabine was unable to better the active control in terms of overall survival.
The top-line data confirm an outcome that looked likely from the minute independent advisers told Cyclacel the study had failed an interim futility review in December 2014. By then, the phase 3 trial had chalked up 247 of the 424 patient deaths needed to trigger the end of the study. But, with the review finding no safety issues that would force Cyclacel to shutter the study, the NJ-based biotech pushed ahead regardless.
A little more than two years later, Cyclacel has learnt sapacitabine is no better at improving overall survival in elderly patients with AML than decitabine, an Otsuka drug FDA rejected in the indication in 2012 on the basis that it also failed to outperform the control arm in its own study. Decitabine, sold under the name Dacogen as a treatment for myelodysplastic syndromes, is used off-label in elderly AML patients because of the dearth of options in this population.
When combined with the performance of sapacitabine against some secondary endpoints, the lack of options for elderly patients with AML who cannot or will not undergo chemotherapy has given Cyclacel encouragement to continue seeking a way forward for the drug.
“We plan to discuss the data with European and U.S. regulatory authorities once subgroup analyses are completed over the next few months and will report our further plans as they develop,” CEO Spiro Rombotis said in a statement.
Rombotis and the chair of the phase 3, MD Anderson’s Hagop Kantarjian M.D., picked out the data on complete remission and safety as cause for optimism. Kantarjian, a critic of FDA’s decision to reject decitabine in AML, called the improved rate of complete remission “remarkable.” Cyclacel said the safety of the two arms was similar.
While Rombotis and Kantarjian see the data as suggesting it is still too early to write off sapacitabine, investors were less optimistic. Cyclacel dropped 30% in premarket trading, adding further woes to a stock that is down 99% on the highs it hit a decade ago. The company’s market cap prior to news of the latest setback stood at $24 million.
資料來源：http://www.fiercebiotech.com/…/cyclacel-aml-drug-fails-phas…