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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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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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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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What is the "insider" behind the occupation of large tracts of anticancer drugs in the past 10 years?
Time of Update: 2021-10-01
The reason for the high market sales of immunosuppressive drugs in the past 10 years is still because of "cancer .
Figure 3 2011-2020 global sales statistics of protein kinase inhibitors in TOP100 drugs Data source: Yaozhi global best-selling drug sales database, compiled by Yaozhi Consulting Unexpected performance of vaccine drugsUnexpected performance of vaccine drugs 1.
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UK issues guidelines explaining precautions for remote clinical trial monitoring
Time of Update: 2021-10-01
The “Sponsor’s Representative’s Access to Electronic Health Records in Clinical Trials” guidelines issued by the MHRA on September 8 stated that remote monitoring can be achieved by allowing the sponsor’s designated clinical trial monitors/inspectors to directly access the trial subjects’ Electronic health records (EHR) should be completed, but appropriate security measures should be taken to ensure patient privacy .
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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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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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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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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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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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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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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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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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GSK and AbbVie are both under development, and Betta Pharmaceuticals and Jiaxi Pharmaceuticals are accelerating. What is the development potential of BET inhibitors?
Time of Update: 2021-09-19
Recently, the research and development of BET inhibitor drugs has successively ushered in new progress. Many Chinese companies including Betta Pharmaceuticals, Gacus Pharmaceuticals, and Wenda Pharm
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The latest license-out!
Time of Update: 2021-09-19
Not long ago, on August 27, Biotech and Hikma jointly announced the signing of an exclusive commercialization and licensing agreement for BAT2206 (a biosimilar developed with reference to Starnox® Usnumab) in the US market.
