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Foreign media: EU may not approve Merck's new crown oral drug molnupiravir
Time of Update: 2022-05-02
Article source: Medical Cube InfoAuthor: infoAccording to Endpoints news, the European Medicines Agency (EMA) is likely to reject Merck's emergency use authorization application for the new crown oral drug molnupiravir, because the clinical data of molnupiravir is less satisfactory than other new crown drugs .
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New Crown Recombinant Protein Vaccine Phase 3 Clinical Results Announcement Plan to Seek Regulatory Authorization
Time of Update: 2022-05-02
On February 24, Sanofi and GlaxoSmithKline (GSK) announced that the two sides plan to simultaneously submit phase 3 efficacy trial data of their jointly developed recombinant protein new crown vaccine and clinical data as a booster needle to seek regulatory approved .
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When the introduction of new drugs by pharmaceutical companies has become the norm, two major drawbacks are gradually emerging
Time of Update: 2022-05-02
4 billion yuan to introduce Dalian Wanchun Brin's first-in-class new drug GEF-H1 activator punabulin, and then with 30 million US dollars, obtained Tianguangshi's third-generation CD20 monoclonal antibody MIL62 in China.
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In 2022, domestic pharmaceutical companies will accelerate the market for original research drugs
Time of Update: 2022-05-02
Prior to this, Chengdu Baiyu Pharmaceutical entered the administrative approval stage with its generic apixaban tablet, which was reported to be produced in Category 4, and is expected to become the company's second over-reviewed antithrombotic drug.
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The "Physician Law" has opened the legal floodgate for the implementation of off-label drug use today?
Time of Update: 2022-05-02
The second paragraph of Article 29 of the "Physicians' Law" clearly stipulates that "in special circumstances such as no effective or better treatment methods, after obtaining the patient's explicit informed consent, the physician may use the drug instructions that are not specified but have evidence-based methods.
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In 2021, several companies in the pharmaceutical industry are happy and some are sad, and these pharmaceutical companies have suffered huge losses
Time of Update: 2022-05-02
For example, according to the more than 240 A-share pharmaceutical companies that have disclosed their performance forecasts, 13 pharmaceutical companies have a net profit of more than 2 billion yuan, which is gratifying .
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Overview of domestic drug candidates in preparation for KRAS targets
Time of Update: 2022-05-02
In July 2020, BeiGene submitted a clinical trial application for this drug in China, and it has been approved for clinical use; in mid-January 2021, the CDE official website showed that the KRAS G12C inhibitor AMG 510 ( Sotorasib) was included in the proposed breakthrough therapy category, and the proposed indication is patients with locally advanced or metastatic non-small cell lung cancer carrying KRAS p.
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The ophthalmology track is popular, and a batch of domestic new drugs is about to be launched
Time of Update: 2022-05-02
In recent years, a large number of pharmaceutical companies in China have begun to flood into the new ophthalmic drug track .
For example, on February 17, the China Drug Clinical Trial Registration and Information Publicity Platform showed that Zhaoke Ophthalmology Co.
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The peptide drug market has broad prospects, but it still faces 3 major challenges
Time of Update: 2022-05-02
Compared with small molecules, the development of peptide drugs is more complicated, and the company may not be able to meet the challenges by itself, and it needs to cooperate with other companies at different stages .
At present, domestic companies in the CDMO field of peptide drugs include Ambio Pharmaceuticals, Sino Bio, Nuotai Bio, Asymchem, etc.
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Guiding Opinions on the Application of Principles in Paragraph 2 of Article 117 of the Drug Administration Law issued
Time of Update: 2022-05-02
On February 24, the General Department of the State Food and Drug Administration issued an announcement stating that in order to further standardize the handling of administrative punishment cases fo
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Concerned about rare diseases, domestic hemophilia patients urgently need to get rid of the new dilemma of "inaccessible medicine"
Time of Update: 2022-05-02
In this regard, the majority of hemophilia patients through an open letter called on Roche Pharmaceuticals to put patients first and reduce the sales price of Emicizumab injection, in order to better benefit rare disease patients and enter the national medical insurance catalogue as soon as possible.
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New addition to the list of breakthrough therapy drugs for the treatment of lung cancer
Time of Update: 2022-05-02
On March 1, Innovent Bio and Baoyuan Pharmaceutical jointly announced that talatinib has been included in the list of breakthrough therapy drugs by the Center for Drug Evaluation of the State Food and Drug Administration, and the proposed indication is a ROS1 tyrosine kinase inhibitor that has not been previously (TKI) therapy and ROS1 fusion-positive non-small cell lung cancer patients previously treated with a ROS1 TKI .
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The online channel for selected drugs in the national centralized drug procurement (insulin special) opens
Time of Update: 2022-05-02
From March 1, 2022, the enterprise will log in to the "Shanghai Pharmaceutical Procurement Service and Supervision Information System" to enter the "Drug Declaration" sub-column, and select "National Drug Collection Selected Variety" in the online type to report related to the selected drugs in Shanghai.
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ZSP1273 Tablets, a subsidiary of Zhongsheng Pharmaceutical, received the US FDA Clinical Trial Approval Notice
Time of Update: 2022-05-02
On March 1, Zhongsheng Pharmaceutical issued a corporate announcement. The announcement stated that recently, Zhongsheng Ruichuang, a subsidiary of Zhongsheng Pharmaceutical, has received a drug clin
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The innovation and development of the traditional Chinese medicine industry is accelerating, and traditional Chinese medicine enterprises need to seize the opportunity
Time of Update: 2022-05-02
Specifically, the "Measures" are proposed from five aspects: encouraging R&D and innovation to promote the high-quality development of traditional Chinese medicine innovation, strengthening the management of traditional Chinese medicine and preparations in medical institutions, further strengthening the guidance of traditional Chinese medicine, strengthening the quality supervision during and after the event, and strengthening inter-departmental communication and coordination.
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The world's first!
Time of Update: 2022-05-02
CompilenewbornRecently, GlaxoSmithKline (GSK) and Canadian biopharmaceutical company Medicago jointly announced that Health Canada has approved the new crown vaccine product Covifenz (plant-based virus-like particle [VLP], recombinant, adjuvant) .
In December 2021, GSK and Medicago announced the results of the Covifenz global Phase 3 placebo-controlled vaccine efficacy study .
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Chain pharmacy giants accelerate the deployment of "dual channels", what should small and medium-sized chains do?
Time of Update: 2022-05-02
Since 2019, an increasing number of provinces and prefectures have introduced a "dual-channel" model, leveraging the flexibility of retail pharmacies to expedite the delivery of high-priced medicines covered by medical insurance outside the hospital .
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A number of medical companies submit their forms again after the IPO "failed"
Time of Update: 2022-05-02
This means that Inference Medical's first sprint for listing on the Hong Kong Stock Exchange failed .
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Novartis Sandoz launches a generic version of Revlimid, the original BMS drug, facing impact!
Time of Update: 2022-05-02
CompilenewbornSince Bristol-Myers Squibb bought Celgene and its superblockbuster Revlimid (lenalidomide) for $74 billion in 2019, the company has been facing generics for the multiple myeloma star drug Prepare for the day of the shock .
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The Yangtze River Delta (Shanghai, Zhejiang and Anhui) Alliance will open bids on February 25
Time of Update: 2022-05-02
On February 23, 2022, the Shanghai Pharmaceutical Centralized Bidding and Purchasing Administration issued the precautions for submitting application materials for centralized drug procurement in the Yangtze River Delta (Shanghai, Zhejiang and Anhui) Alliance .
