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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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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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The big transformation of Shandong pharmaceutical enterprises!
Time of Update: 2021-09-05
0 Chinese Drug Evaluation DatabaseAt present, there are 9 new registered classification varieties (11 acceptance numbers) under review by New Era Pharmaceuticals, and they will be deemed to have passed the consistency evaluation after being approved for production .
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Yang Xinqiu, deputy general manager of Ruizhi Pharmaceutical, resigns
Time of Update: 2021-09-05
On August 10, Ruizhi Pharmaceutical issued an announcement stating that the company had recently received a written resignation application report submitted by Deputy General Manager Yang Xinqiu.
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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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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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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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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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National talks varieties soared by 6000%! 27 Class 1 new drugs to challenge Hengrui and Renfu to fight again
Time of Update: 2021-09-05
In recent years, with the improvement of the R&D capabilities of domestic pharmaceutical companies and the acceleration of review and approval, more and more new drugs have entered the market.
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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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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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WuXi Giant Noreki Oronza injection is about to be approved or become the second CAR-T product in China
Time of Update: 2021-09-05
FinishingRheeToday, China's National Food and Drug Administration (NMPA) announced that the listing application of WuXi's Noreji Orencil injection (relma-cel) has entered the "pending approval" status and is expected to be approved in China in the near future .
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Another AD drug!
Time of Update: 2021-09-05
In June of this year, Aduhelm developed by Biogen and Eisai was approved by the FDA, becoming the first approved drug for Alzheimer's disease in the United States in the past 20 years .
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Drug Administration: Nanchang Huayi's first batch of medical devices is being recalled
Time of Update: 2021-09-05
On August 19, the State Food and Drug Administration issued an announcement to notify Nanchang Huayi of its voluntary recall of some of its products in violation of regulations .
The company immediately initiated the recall procedure for this batch of products .
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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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Treat chronic hepatitis B! GSK antisense oligonucleotide drug approved for clinical use
Time of Update: 2021-09-05
Therefore, after stopping the drug, the recurrence rate of chronic hepatitis B is very high,GSK3228836 is an antisense oligonucleotide that can specifically recognize the mRNA used to express viral antigens (pathogenic proteins) in liver cells infected with HBV, and inactivate viral mRNAs by mobilizing the liver’s own enzymes to inhibit viral proteins HBsAg levels in order to achieve the functional purpose of curing hepatitis B .
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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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Two pharmacies in Luohe City, Henan Province fined 300,000 yuan for selling anti-fever drugs
Time of Update: 2021-09-05
Case 2: A pharmacy in Lucheng District, Luohe City illegally sold anti-fever medicines and did not store medicines in accordance with statutory conditions and was fined 200,000 yuanOn August 11, law enforcement officers of the Lucheng Branch of the Market Supervision Bureau of Luohe City inspected the pharmacies in the jurisdiction and found that the Xindian Pharmacy of the Lucheng District Pharmaceutical Company in Luohe City illegally sold the antipyretic acetaminophen capsules during the epidemic period without a sales certificate.
