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The more setbacks, the more courageous! In 2023, the general trend of domestic innovation going overseas will not change
Time of Update: 2023-02-02
Recently, local pharmaceutical companies such as WuXi Biologics, Akeso, and Kelun Pharmaceutical have all reported good news about license-out, which has once again boosted the confidence of domestic innovative drugs to enter the international market.
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Notice on the public solicitation of opinions on the "Technical Guidelines for the Design of Clinical Trials of Non-opioid Postoperative Analgesic New Drugs"
Time of Update: 2023-02-02
Notice on the public solicitation of opinions on the "Technical Guidelines for the Design of Clinical Trials of Non-opioid Postoperative Analgesic New Drugs"Release date: 20221222 In order to scientifically guide and standardize the clinical research and development of such drugs in China, the Center for Drug Evaluation organized and wrote the "Technical Guidelines for the Design of Clinical Trials of Non-opioid Postoperative Analgesic New Drugs", and formed a draft for comments.
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In the first 11 months of 2022, the participation rate of basic medical insurance nationwide was stable at more than 95%.
Time of Update: 2023-02-02
The income of the basic medical insurance fund for urban and rural residents was 851.
The income of the basic medical insurance fund for urban and rural residents was 851.
The income of the basic medical insurance fund for urban and rural residents was 851.
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Global gene sequencing leader lowers 2023 performance guidance, the market is being "snapped up" by domestic enterprises
Time of Update: 2023-02-02
js?cdnversion='+~(-new Date()/36e5)];Recently, Illumina, the head manufacturer of global gene sequencing instruments, announced that it would lower its performance guidance for 2023 and was lower than market expectations.
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NMPA solicits opinions on the Measures for the Administration of Drug Standards, and Chinese Pharmacopoeia and drug standards are national standards!
Time of Update: 2023-02-02
Chapter III: Planning and Project Establishment Article 16 (Work Plan for National Drug Standards) The drug regulatory department under the State Council shall organize the National Pharmacopoeia Commission to formulate the outline for the preparation of the Chinese Pharmacopoeia, which shall be implemented after deliberation and approval by the plenary meeting of the Pharmacopoeia Committee.
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The National Health Commission issued the 14th Five-Year Plan for Emergency Medical Rescue
Time of Update: 2023-02-02
Health commissions of all provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps: In order to strengthen emergency medi
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Due to the failure to meet the expected data, some pharmaceutical companies announced the suspension of new drug research
Time of Update: 2023-02-02
js?cdnversion='+~(-new Date()/36e5)];Gene editing company Graphite Bio announced a voluntary moratorium on the phase 1/2 CEDAR study of nulabeglene autogedtemcel (nula-cell, GPH101) in sickle cell disease (SCD).
js?cdnversion='+~(-new Date()/36e5)];Gene editing company Graphite Bio announced a voluntary moratorium on the phase 1/2 CEDAR study of nulabeglene autogedtemcel (nula-cell, GPH101) in sickle cell disease (SCD).
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Junshi PD-1 chases the deer in the Middle East! East China Pharmaceutical, Henlius, BeiGene...The "Belt and Road" market has become a blue ocean of innovative drugs in China?
Time of Update: 2023-02-02
On December 25, Junshi Biologics announced that it has reached a cooperation with Hikma MENA FZE (hereinafter referred to as "Hikma") for its PD-1 drug teripulimab. According to the announcement, Jun
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Yang Sheng: Deepen the reform of drug review and approval and promote the high-quality development of the pharmaceutical industry
Time of Update: 2023-02-02
As China's drug regulatory reform has entered a new stage, in recent years, the State Drug Administration has issued a series of policies and regulations in deepening the reform of drug review and ap
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The sour jujube kernel market is running at a high level, and the health yuan needs to control the cost of raw materials!
Time of Update: 2023-02-02
According to the third quarterly report of 2022 released by Health Yuan Pharmaceutical Group Co. , Ltd. (Health Yuan, 600380), the operating income in the first three quarters of 2022 was 13. 012 bil
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Notice of the Center for Drug Evaluation of the State Medical Products Administration on publicizing the list of clinical external experts for technical review of children's medication
Time of Update: 2023-02-02
Notice of the Center for Drug Evaluation of the State Medical Products Administration on publicizing the list of clinical external experts for technical review of children's medicationRelease date: 2
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Notice on the public solicitation of recommendations and Chinese version of ICH S1B(R1): Carcinogenicity Research
Time of Update: 2023-02-02
S1B (R1) English version Center for Drug Evaluation, State Medical Products Administration December 22, 2022In order to promote the smooth implementation of the newly revised ICH guidelines in China, our center has formulated the implementation recommendations of "S1B(R1): Carcinogenicity Research" and organized the translation of Chinese editions.
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The global ophthalmic drug track competition has opened, and domestic pharmaceutical companies are increasing their layout
Time of Update: 2023-02-02
acquisition On January 9, Puri Eye announced that Dongguan Guangming Eye Hospital recently obtained the business license and "Registration Notice" issued by the Dongguan Market Supervision Administration, and the acquisition of 35% of the equity of Dongguan Guangming Eye Hospital by Chuangfa Enterprise has completed the registration procedures for industrial and commercial changes.
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The Anhui Provincial Food and Drug Administration issued the implementation rules for the grading supervision of medical device production
Time of Update: 2023-02-02
Recently, the Anhui Provincial Food and Drug Administration took the lead in promulgating the Implementation Rules for the Graded Supervision of Medical Device Production in Anhui Province (hereinaft
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The key points of quality system construction based on "MAH Implementing the Provisions on the Supervision and Management of Drug Quality Subject Responsibility"
Time of Update: 2023-02-02
Quality Assignee's responsibilities and requirements Pharmacy or related professional background, bachelor degree or above or intermediate or above professional and technical title or licensed pharmacist qualification, more than five years of practical experience in drug production and quality management, engaged in drug production process control and quality inspection, familiar with relevant laws, regulations and rules and regulations of drug supervision and administration.
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At the beginning of the new year, the pharmaceutical industry has begun to set off a wave of repurchases!
Time of Update: 2023-02-02
On January 9, Guizhou Bailing announced that it intends to repurchase the company's shares for 100 million to 200 million yuan for the later implementation of equity incentives or employee stock ownership plans.
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In order to accelerate transformation, traditional pharmaceutical companies and Biotech cooperation mergers and acquisitions have become the norm!
Time of Update: 2023-02-02
js?cdnversion='+~(-new Date()/36e5)];Recently, another traditional pharmaceutical company and Biotech announced a merger and acquisition!
js?cdnversion='+~(-new Date()/36e5)];Recently, another traditional pharmaceutical company and Biotech announced a merger and acquisition!
js?cdnversion='+~(-new Date()/36e5)];Recently, another traditional pharmaceutical company and Biotech announced a merger and acquisition!
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Pharmaceutical equipment enterprises and pharmaceutical companies continue to "marry" and jointly break the digital transformation and upgrading
Time of Update: 2023-02-02
Not long ago, Zhejiang Canaan Zhiyao officially signed a contract with Shenhua Pharmaceutical's oral liquid production line MES system project, and the two sides reached a strategic cooperation to jo
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The "first" new drug approved by the FDA in 2022: involving TCR therapy, fecal bacterial therapy, bispecific antibodies, gene therapy, etc
Time of Update: 2023-02-02
6. Tecvayli(teclistamab) In November 2022, the FDA approved Tecvayli for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) who had previously received 4 or more lines of therapy (including proteasome inhibitors, immunomodulators, anti-CD38 monoclonal antibodies).
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In 2022, the US FDA approved the inventory of innovative drugs: BMS, Roche, Legend Bio and other products were successfully launched
Time of Update: 2023-02-02
Hengrui Pharmaceutical has introduced the drug and submitted a new drug application in China in January this year BMS is another FIC drug On April 28, Bristol-Myers Squibb (BMS) mavacamten was approved by the FDA for the treatment of adult patients with obstructive hypertrophic cardiomyopathy (oHCM) rated class II-III according to the New York Heart Association's functional scale (NYHA) to improve exercise capacity and symptoms.
