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Ocular terminates cooperation with Regeneron to develop aflibercept sustained-release formulations
Time of Update: 2021-09-05
Compiler: Fan DongdongA few days ago, Ocular Therapeutix and Regeneron announced the termination of their cooperation and the suspension of the development of aflibercept sustained-release preparations for the treatment of wet age-related macular degeneration (AMD) and other serious retinal diseases.
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Hengrui Medicine's 3 new drugs approved for clinical treatment of diabetes and tumors
Time of Update: 2021-09-05
According to the latest announcement by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, Hengrui Medicine's three new biological drugs have recently obtained
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Innovative drug HSK21542 injection, a wholly-owned subsidiary of Haisco obtains clinical approval
Time of Update: 2021-09-05
According to the "Drug Administration Law of the People's Republic of China" and related regulations, after review, the HSK21542 injection accepted on May 12, 2021 meets the relevant requirements of drug registration, and it is agreed to carry out the phase II clinical trial of "liver disease itching" .
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Hengrui continues to make efforts to ADC!
Time of Update: 2021-09-05
Today, the official website of CDE shows that Hengrui has declared a new ADC product SHR-A1921 .
At present, including SHR-A1921, Hengrui has 7 ADC projects that have reached the clinical stage, 4 of which are new clinical projects declared in 2021, as shown in the figure below:Hengrui clinical stage ADC pipeline*From top to bottom in order of clinical application time
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Zejing Pharmaceutical: Disclosure of research and development progress of Donafinil tosylate tablets
Time of Update: 2021-09-05
On the 16th, Zejing Pharmaceutical issued an announcement stating that Donafinil Tosylate Tablets is a multi-center, randomized, double-blind, placebo-controlled treatment of locally advanced/metastatic radioiodine refractory differentiated thyroid cancer (RAIR-DTC) The Phase III clinical trial (code name: ZGDD3) carried out a preset interim analysis, and the Independent Data Monitoring Committee (IDMC) reviewed the results and determined that the effectiveness and safety results were in line with expectations .
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Eli Lilly's breast cancer drug Verzenios is recommended by NICE
Time of Update: 2021-09-05
CompilationTom LeeA few days ago, the draft NICE guidelines have recommended Eli Lilly's oral Verzenios (abemaciclib) twice a day for the treatment of hormone receptor-positive, HER2-negative breast cancer in adult patients with breast cancer that has spread to other parts of the body .
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Jisi Yingda ERK kinase inhibitor was approved for clinical use
Time of Update: 2021-09-05
On August 16, JSI Indah announced that it had received the "Clinical Trial Notice" approved and issued by the National Medical Products Administration, and its extracellular regulated kinase (ERK) inhibitor JSI-1187 capsule was approved for treatment A clinical trial of patients with advanced solid tumors with mutations in the MAPK signaling pathway .
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Hebei Provincial Drug Administration: Remove restrictions on distance and business area for pharmaceutical retail companies
Time of Update: 2021-09-05
According to the "Notice on Optimizing the Approval for the Establishment of Pharmacies" (hereinafter referred to as the "Notice") issued by the Hebei Provincial Drug Administration recently, it is necessary to continue to optimize the approval services for the establishment of pharmacies, and to abolish the requirements for the set distance and business area of pharmaceutical retail companies.
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Why is it costing 70 billion to buy a loss-making pharmaceutical company?
Time of Update: 2021-09-05
At this time, it’s better to take a look at this company that makes Gilead willing to spend a lot of money, and what kind of medicine is sold in the gourd—Pharmasset is holding the PSI (Pharmasset small inhibitor)-7977 in the third phase of clinical trials— -A very promising hepatitis C treatment drug .
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Covid-19 vaccine from different manufacturers mixed, the third injection and the sequential immunization booster
Time of Update: 2021-09-05
Before the completion of the immunization program, the cross-manufacturer mix, the third injection, and whether the sequential immunization of vaccines with different technical routes can be carried out and whether they can cope with variant strains are the focus of recent industry attention .
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Comparison of EGFR Exon20 inhibitors: Johnson & Johnson Amivantamab vs Takeda Mobocertinib
Time of Update: 2021-09-05
On July 12, the marketing authorization application (NDA) of the innovative drug Mobocertinib (TAK-788), which was certified by China and the United States for breakthrough therapy, was officially acc
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Eisai's anti-epileptic drug receives 2 additional approvals from the National Food and Drug Administration
Time of Update: 2021-09-05
Eisai recently announced that its internally discovered and developed anti-epileptic drug Fycompa (Weiketai®, generic name: perampanel, perampanel) has received two additional approvals from the National Medical Products Administration (NMPA) of China : (1) As a single-drug therapy for the treatment of partial-onset epilepsy; (2) Pediatric indications: As an adjuvant therapy/monotherapy, used for the treatment of partial-onset epilepsy in pediatric epilepsy patients ≥ 4 years old .
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Anke Bio-Human Growth Hormone Injection has two new specifications
Time of Update: 2021-09-05
The therapeutic biological product "Human Growth Hormone Injection" independently developed by Anke Biological was approved by the National Food and Drug Administration in June 2019 (Specifications: 4IU/1.
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A large number of drugs are transferred out of medical insurance
Time of Update: 2021-09-05
01 On January 1, next year, a large number of drugs will be transferred out of medical insurance01 On January 1, next year, a large number of drugs will be transferred out of medical insuranceGuizhou (339)On August 3, the Guizhou Medical Insurance Bureau and the Guizhou Department of Human Resources and Social Security issued the "Notice Regarding the Transfer of Some Medicines from the "Guizhou Province Basic Medical Insurance Work Injury Insurance and Maternity Insurance Drug List (2021)", stating:1.
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Corning Jerry's HER2 bispecific antibody liquid preparation is approved for clinical use
Time of Update: 2021-09-05
Text|Pharmaceutical Mission HillsOn August 17, Corning Jereh announced that the National Medical Products Administration (NMPA) of China has approved its supplementary application for the pharmaceutical change of the recombinant humanized anti-HER2 bispecific antibody KN026, and agreed that liquid preparations can be used for subsequent clinical studies .
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Talk about the surrounding legal affairs of the drug patent link system
Time of Update: 2021-09-05
There is still no stipulation (many colleagues in the industry have always held a negative attitude towards the treatment of "fictitious infringement" in the United States), but from the perspective of "whether the relevant technical solutions of the drug applied for listing fall within the protection scope of the relevant patent rights" The legal basis for generic drug companies to submit for marketing approval before the expiration of the original research drug patent .
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Pfizer and Ferring have reached a collaboration on degarelix acetate for prostate cancer drug injection
Time of Update: 2021-09-05
On August 17, Pfizer and Ferring formally announced that the two parties have reached a cooperation agreement on Ferring’s authorization of Pfizer to exclusively be responsible for the commercial operation of degarelix acetate (brand name: Feimenger®), an innovative drug for the treatment of prostate cancer, in mainland China.
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Eisai Perampanel approved for 2 new indications
Time of Update: 2021-09-05
In September 2019, Perampanel was approved for marketing in China for the add-on treatment of patients with partial epilepsy (with or without secondary generalized seizures) aged 12 years and older .
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Beijing Food and Drug Administration Revises 63 Chinese Herbal Pieces Processing Regulations
Time of Update: 2021-09-05
On August 11, the Beijing Municipal Food and Drug Administration issued a notice on the public solicitation of opinions on the revised varieties (second batch) of the "Beijing Regulations for the Processing of Chinese Herbal Medicines" (2008 Edition) .
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Pfizer China President Substitution
Time of Update: 2021-09-05
FinishingrainbowOn the evening of August 5, it was reported that Pfizer Biopharmaceutical Group will appoint Peng Zhenke (JC) as the president of China.
After the appointment, Zhenke Peng will join the global leadership team of Pfizer Biopharmaceuticals and report to the group president Huang Weiming .
