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Cinda's first small-molecule anti-cancer drug, pemigatinib tablet, applied for listing
Time of Update: 2021-08-06
On July 9th, Innovent announced that NMPA has officially accepted the application for the fibroblast growth factor receptor (FGFR) 1/2/3 inhibitor (pemigatinib tablet) for the market, for at least one systemic treatment in the past, and Adult patients with advanced, metastatic or unresectable cholangiocarcinoma with FGFR2 fusion or rearrangement confirmed by testing .
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Baiyunshan amoxicillin capsule passed the consistency evaluation
Time of Update: 2021-08-06
The amoxicillin capsule of Baiyunshan Pharmaceutical General Factory was officially launched in China in August 2006, and the consistency evaluation application was submitted to the National Medical Products Administration on November 4, 2018, and it was accepted on November 12, 2018 .
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Application of GLS in R&D Quality Management
Time of Update: 2021-08-06
Regarding the quality management of drug research and development, in fact, from the national regulatory level, the regulations do not make a clear requirement for the quality management of the research and development stage .
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Guangdong Provincial Food and Drug Administration: Many pharmaceutical companies have delisted their sales licenses!
Time of Update: 2021-08-06
On July 12, the Guangdong Provincial Food and Drug Administration issued the "Notice on the Cancellation of the "Pharmaceutical Business License" and announced the cancellation of the "Pharmaceutical Business License" of 6 companies .
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Biogen AD's new drug Aduhelm was criticized again by senior FDA officials requesting a federal investigation
Time of Update: 2021-08-06
Acting FDA Commissioner Janet Woodcock called on the Office of Inspector General (OIG) to initiate a federal investigation into the approval of Aduhelm for the treatment of Alzheimer's disease .
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Tiger Medicine: Tiger Equity intends to invest 9.8 billion yuan to set up a biomedical industry fund
Time of Update: 2021-08-06
Tailong Investment will subscribe RMB 200 million as a general partner and fund manager, with a subscribed capital contribution ratio of 1% .
Tiger Equity is a limited partner of Tailong Investment, with a subscribed capital of RMB 198 million, accounting for 99% of the total capital contribution of Tailong Investment .
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Is the 1-year market exclusivity period of Zhengda Tianqing's "lenvatinib" stable?
Time of Update: 2021-08-06
Before the "Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial)" is issued, generic drugs can be accepted and reviewed by CDE without a declaration when they submit their marketing applications, and technical review and administrative approval can be initiated .
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Shanghai's "4+7" varieties were collected from Qilu, Jingxin and other enterprises to win the bid
Time of Update: 2021-08-06
According to the Shanghai centralized procurement documents, the criteria for determining the drug to be selected is that the "comparable unit price" of the final drug meets one of the following conditions, and the comprehensive score is calculated according to the "comprehensive bidding index system", and the company with the highest score is proposed to be selected:(1) "Comparable unit price" ≤ 1.
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Keeping integrity and innovation to make up for the shortcomings of TCM: TCM culture development seminar held in Nanyang
Time of Update: 2021-08-06
Wang Guowei, former vice-president and chief physician of the Department of Internal Medicine of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University, said that at present, the public can basically accept the concept of health preservation of Chinese medicine, but the science of Chinese medicine culture and Chinese medicine treatment thinking still needs to be promoted.
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Jixing Pharmaceutical Appoints Luo Wanli as Chief Executive Officer
Time of Update: 2021-08-06
On July 14, the biopharmaceutical company Jixing Pharmaceutical announced the appointment of Mr.
In addition, he briefly served as President of Merck's US Human Health Division, responsible for managing the market with the largest revenue .
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New Thinking on Drug Purchase in Volume: From Encounter to Tug of War
Time of Update: 2021-08-06
Full competition is no longer emphasized, and large amounts and high amounts have become decisive optionsThe "Opinions of the General Office of the State Council on Promoting the Normalized and Institutionalized Development of Centralized and Volumetric Procurement of Drugs" (Guobanfa [2021] No.
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The new crown vaccine will have a third shot?
Time of Update: 2021-08-06
The press release pointed out that preliminary data indicated that the sera of subjects who received the third booster vaccine 6 months after the second vaccination showed high titers against wild-type virus strains and Beta variants (B.
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Betta Pharmaceuticals accepted the application for registration of first-line treatment indication drugs for Ensatinib Hydrochloride
Time of Update: 2021-08-06
On July 13, Betta Pharmaceuticals announced that it had received the "Notice of Acceptance" (acceptance number: CXHS2101028 country, CXHS2101029 country) issued by the State Food and Drug Administration, and the company declared Ensatinib Hydrochloride Capsules (Bemena ®) The application for marketing authorization for "applicable to the treatment of patients with anaplastic lymphoma kinase (ALK) positive locally advanced or metastatic non-small cell lung cancer (NSCLC)" has been accepted by the State Food and Drug Administration .
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Return of the Great Sage
Time of Update: 2021-08-06
Does the King of Medicine mean the same thing this time?It is also a comeback to take the banner again, but Sun Piaoyang and Liu Chuanzhi's personalities are different .
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Controversy between Me-too and FIC routes
Time of Update: 2021-08-06
The most important step for a new target is the phase 2 clinical proof of concept, so in my opinion, the manufacturer that completed this POC has undertaken the most technical risk, which should be regarded as FIC, but due to various reasons, it may not be the first to market this new Mechanism drugs .
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Pfizer's third-generation ALK inhibitor plans to be included in priority review in China
Time of Update: 2021-08-06
Today, CDE announced that two applications for Pfizer’s lorlatinib tablets have been included in the proposed priority review, and it is planned to develop the treatment of specific ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) patients .
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Hiscoperindopril and indapamide tablets enter administrative approval and will win the first imitation of compound antihypertensive drugs
Time of Update: 2021-08-06
According to data from Meinenet, the total sales of perindopril and indapamide in China's public medical institutions and physical pharmacies in Chinese cities in 2020 will exceed 300 million yuan .
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AbbVie: Who will bear the burden after taking over the king of medicine Humira?
Time of Update: 2021-08-06
Skyrizi is approved for indications (Source: NextPharm)In terms of market sales, Rezalizumab has surpassed the earlier similar drug Gusekizumab .
Earlier this year, Rezalizumab also obtained positive data in the field of Crohn's disease; in April, the indication for adult active psoriatic arthritis also submitted a marketing application to the FDA and EMA .
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Sanofi announces Dupixent's 10 billion goal of chronic spontaneous urticaria may be achieved
Time of Update: 2021-08-05
Sibold said in a conference call on Thursday that Dupixent currently has annual sales of 5 billion euros .
The vaccine business generated 1 billion euros in revenue during the quarter, an increase of 16% .
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Qilu Pharmaceutical's new pancreatic cancer drug was approved for clinical use
Time of Update: 2021-08-05
The Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China has announced that the CEND-1 for injection introduced by Qilu Pharmaceutical has obtained an implied license for a clinical trial and is intended to be developed for the first-line treatment of advanced metastatic pancreatic cancer .
