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FDA releases pre-conference materials for Pfizer's new crown vaccine booster vaccination expert meeting, skeptical about booster vaccination
Time of Update: 2021-10-01
[The outgoing FDA Vaccine Office Director and Deputy Director Lancet issued a post saying that the current data does not support the new crown vaccine booster vaccination September 14, 2021] In a briefing document released on Wednesday, Pfizer stated that the effectiveness of its vaccine is declining and that the effectiveness of the third dose of the vaccine will return to the 95% level seen in clinical trials .
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Domestic research and development pattern of new macromolecule drugs
Time of Update: 2021-10-01
New antibody drugs such as double antibodies and ADCs have become important paths for differentiated innovation .
Corning Jerry's HER2 double antibody and PD-L1/CTLA-4 have reached an important cooperation agreement with CSPC, and new progress has been continuously made in clinical aspects .
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Precise treatment of elderly cancer patients has become an increasingly tangled medical problem
Time of Update: 2021-10-01
Improve precise treatment decisions for elderly cancer patients:Improve precise treatment decisions for elderly cancer patients: For clinical evidence and trial design, we provide seminar expert lecture materials, including clinical diagnosis and treatment methods; how to judge the benefit of patients, improve and guarantee the quality of life and give priority to survival time (hope for recovery) .
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U.S. drug traceability is struggling: industry calls on FDA to withdraw electronic traceability guidelines
Time of Update: 2021-10-01
McKesson, one of the three major drug procurement and distribution alliance members in the United States, agrees with HDA's opinion and also believes that the guidelines allow FDA to access electronic systems of trading partners beyond DSCSA's statutory intent .
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Obtained FDA approval two and a half months ahead of schedule for multi-kinase inhibitors to obtain new indications
Time of Update: 2021-10-01
Reference materials:Reference materials: [1] Exelixis Announces US FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer.
from https:// en[1] Exelixis Announces US FDA Approval of CABOMETYX® (cabozantinib) for Patients with Previously Treated Radioactive Iodine-Refractory Differentiated Thyroid Cancer.
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Zai Lab/Amgen's FGFR2b targeted monoclonal antibody has been certified as a breakthrough therapy in China and the U.S.
Time of Update: 2021-10-01
Zai Lab announced recently that CDE has granted bemarituzumab (FPA144 injection) breakthrough therapy designation (BTD), combined with an improved FOLFOX6 chemotherapy regimen (mFOLFOX6: fluoropyrimidine + leucovorin + oxaliplatin), as a first-line treatment for fibroblasts Growth factor receptor 2b (FGFR2b) overexpression, HER2-negative, metastatic and locally advanced gastric and gastroesophageal junction (GEJ) cancer patients .
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An immersive overview — common models and market observations of pharmaceutical cooperative development
Time of Update: 2021-09-30
,、,、, 。,,,, 。 ,(License-in)[1][2] 。: ()(),,()、、,、、、、、、 。 Pharmaceutical equity buyout transactions are the sale/purchase of pharmaceuticals or pharmaceuticals under research in a certain geographical
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Letter from the National Medical Security Administration on the Reply to Proposal No. 3358 (Medical Sports No. 267) at the Fourth Meeting of the 13th National Committee of the Chinese People's Political Consultative Conference
Time of Update: 2021-09-20
Member Wang Hongling: Your proposal regarding the gradual inclusiveness of the medical support policies for poverty alleviation has been received. After doing business with the National Health Commi
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Notice on Public Comment on "Guiding Principles for Comprehensive Analysis of Effectiveness of Drug Clinical Research (Draft for Comment)"
Time of Update: 2021-09-20
pdf Annex 3 : "Guiding Principles for Comprehensive Analysis of Effectiveness of Drug Clinical Research (Draft for Solicitation of Comments)" feedback form for soliciting opinions.
docx Attachment 3: "Guiding Principles for Comprehensive Analysis of Effectiveness of Drug Clinical Research (Draft for Comments)" Soliciting Feedback Form.
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Clinical value orientation makes doctors a part of the pharmaceutical industry chain
Time of Update: 2021-09-20
At the China International Trade Fair on Clinical Oncology and Anti-tumor Drug Innovation and Research Forum held recently, the participating experts agreed that clinical value-oriented anti-tumor drug research and development is an important development direction, and first-line doctors or professors should Actively become a link in the pharmaceutical industry chain .
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CStone's Pratinib Capsules Announces Efficacy and Safety Data in the Treatment of NSCLC Chinese Patients
Time of Update: 2021-09-20
The data show that Pugeta® has long-lasting clinical anti-tumor activity in Chinese patients with RET fusion-positive advanced NSCLC, and the overall safety is controllable, and no new safety signals have been found .
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Threshold for oncology drug development is raised: FDA pays attention to clinical trial dose design
Time of Update: 2021-09-20
Recently, the agency is launching the Optimus project of the FDA Oncology Center of Excellence, which will develop new guidelines for cancer drug manufacturers to explore a wider range of doses in early trials .
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Has the investment boom of the CXO head echelon faded?
Time of Update: 2021-09-20
On July 21, WuXi Biologics issued an announcement that major shareholder WuXi Biologics Holdings placed 80 million shares through a block transaction at a price of 129 Hong Kong dollars, and cashed up to 10.
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UK NICE attitude U-shaped reversal: support Johnson & Johnson Erleada in the treatment of two types of prostate cancer patients
Time of Update: 2021-09-20
Just one month later, in June, NICE recommended Pfizer and Astellas' once-a-day oral drug Xtandi combined with standard androgen deprivation therapy (ADT) to treat patients with metastatic hormone-sensitive prostate cancer (mHSPC) .
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A total of more than 3 billion US dollars: Roche enters allogeneic T cell therapy
Time of Update: 2021-09-20
On September 7, Roche’s subsidiary Genentech and Adaptimmune reached a cooperation to jointly develop allogeneic T cell therapies to treat multiple tumor indications, with a total transaction amount of up to 3 billion US dollars .
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National Food and Drug Administration: Ensure that every new coronavirus vaccine vaccinated by the people is qualified and safe
Time of Update: 2021-09-20
The State Food and Drug Administration puts the promotion of the development and marketing of new coronavirus vaccines as the top priority, and has adopted a series of measures such as timely formulation of guiding principles, joint research and review work, and active participation in international cooperation .
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Can't afford the mouse, can't buy the monkey, how long will this hot track be hot?
Time of Update: 2021-09-20
Mainstream small model animal suppliers are mainly based on this technology to provide model mice, and when the production bottleneck of model monkeys is difficult to break in the short term, large animals such as dogs and pigs modified by CRISPR technology are continuously entering the field of researchers .
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Concord Kirin signed a US$289 million agreement to obtain sepsis assets from Pfizer’s refusal to exercise its option
Time of Update: 2021-09-20
Pfizer abandoned a sepsis project ilofotase alfa in 2018, but now, Concord Kirin is willing to pay US$289 million to obtain AM-Pharma's exclusive license for the project in Japan .
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China's rare disease definition research report released: rare diseases with fewer than 140,000 patients
Time of Update: 2021-09-19
In addition, after the redefinition of rare diseases, orphan drugs also need to have a standard suitable for national conditions, so that China's rare disease prevention and control can be standardized and institutionalized .
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Cinda’s first SIRPα antibody, will CD47/SIRPα be the next piece of the Red Sea?
Time of Update: 2021-09-19
In addition to IBI397, Cinda also has two drugs under development that target the CD47/SIRPα signaling pathway .
(Targeting the mechanism of CD47-SIRPα pathway in tumors Source: [3]) Cinda BioCinda Bio Founded in 2011, Cinda Bio is committed to the development, production and sales of innovative drugs for the treatment of major diseases such as tumors .