-
Generic Drugs | The second domestic Chenxin Pharmaceutical Teriflunomide Generic Drug Application for Production
Time of Update: 2021-04-28
In China, teriflunomide was approved by the NMPA for the treatment of relapsing MS in July 2018, and its trade name is Aubage, becoming the first oral DMT drug approved for marketing in my country.
-
Release of ctDNA analysis results of Betta Pharmaceuticals' Phase 2 study of Ensatinib
Time of Update: 2021-04-28
On March 1, Betta Pharmaceuticals issued a press release stating that the internationally renowned oncology journal "Journal of Thoracic Oncology" (Journal of Thoracic Oncology, JTO) published online
-
Jiangsu Provincial Food and Drug Administration issued notice of Bristol-Myers Squibb's cancellation of drug business license
Time of Update: 2021-04-28
On March 15, the Jiangsu Provincial Food and Drug Administration issued an announcement stating that, in accordance with the "Administrative Licensing Law", "Drug Administration Law", "Drug Distribution License Management Measures" and other relevant regulations, it was approved by Bristol-Myers Squibb (China) Pharmaceutical Co.
-
The National Health Commission released the second batch of catalogs of encouraged generic drugs containing 17 varieties
Time of Update: 2021-04-28
(Insufficient competition) drugs were selected and demonstrated, and the "Second Batch of Encouraged Generic Drugs List" was formulated and released.
It contains 17 varieties:
-
A pharmaceutical company was warned for failing to comply with GMP during the inspection process
Time of Update: 2021-04-28
Violation of "Pharmaceutical Production Quality Management Regulations"The on-site inspection of Fujian Minghua Pharmaceutical Co.
-
Dongyangguang: Application for drug registration of insulin aspart injection has been accepted
Time of Update: 2021-04-28
(hereinafter referred to as "Dongyang Pharmaceutical") insulin aspart injection had received the "Notice of Acceptance" issued by the State Food and Drug Administration.
According to Ai Kunwei data, in 2019, China's diabetes drug sales amount is approximately 3.
-
Authorization to introduce the dilemma again! The product has been approved for listing but was broken up by US$20 million
Time of Update: 2021-04-28
The rights that Beihai Kangcheng acquired at the time was an exclusive license agreement for the development and commercialization of lenatinib in mainland China, Taiwan, Hong Kong and Macau.
-
Ascent Pharma's third-generation BCR-ABL inhibitor plans to be included in breakthrough treatment products
Time of Update: 2021-04-28
Source: Guanlan PharmaceuticalAccording to the latest announcement by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China, Yasheng Pharmaceutical's wholly-owned subsidiary, Shunjian Biologics, a new class 1 drug, nectinib tablets (HQP1351, also known as oribatinib), will be included in the breakthrough treatment Variety, the proposed indication is: for the treatment of chronic myelogenous leukemia (CML) patients who are resistant and/or intolerant to first- and second-generation tyrosine kinase inhibitors.
-
Customers complained about the loose caps of sterile medicines. Pharmaceutical companies took the initiative to recall
Time of Update: 2021-04-28
Picture: Information of the recalled product (product, batch number, expiration date, NDC number, distribution date)Saijin Pharmaceuticals is notifying customers via fax, e-mail, FedEx and/or certified mail, including arrangements for returning all recalled products.
-
Chinese medicine is frequently difficult for companies to return goods
Time of Update: 2021-04-28
Where is the way to improve the quality of traditional Chinese medicine products and avoid excessive levels of 33 pesticide residues?In recent years, the government has given great support to the development of the Chinese medicine industry, and good news continues.
-
C-type natriuretic peptide analogue vosoritide treatment continued to maintain growth levels for 2 years
Time of Update: 2021-04-28
The open label expansion data released at the ENDO21 annual meeting showed that children maintained their annual growth rate (AGV) growth during the second year of continuous vosoritide treatment.
-
Opportunities and challenges coexist in traditional Chinese medicine in Poland
Time of Update: 2021-04-28
This paper is related to the participation in the international training program of the Ministry of Science and Technology "Clinical Practice and Research Progress of Traditional Chinese Medicine" Co-authored by Polish doctors of "Advanced Seminar Project".
-
Guilin Sanjinsun Company BC006 monoclonal antibody injection obtained clinical trial approval
Time of Update: 2021-04-28
("Baochuan Bio"), received a clinical trial of BC006 monoclonal antibody injection approved and issued by the State Drug Administration.
BC006 monoclonal antibody injection is intended to be used for the treatment of advanced malignant tumors, and is expected to solve the unmet medical needs in various solid tumors, hematological tumors, bone and joint diseases and other diseases.
-
The curtain of pharmaceutical industry 4.0 opens: one article to understand 3D printing of drugs
Time of Update: 2021-04-28
Later, compared with traditional formulation technology, 3D printing technology has attracted many pharmaceutical companies and research institutions to explore this with its advantages in product design complexity, personalized drug delivery, and on-demand manufacturing.
-
Hisun Pharmaceutical: Bicalutamide tablets passed the consistency evaluation of generic drugs
Time of Update: 2021-04-28
On March 9th, Hisun Pharmaceutical announced that it received the "Drug Supplementary Application Approval Notice" for bicalutamide tablets approved and issued by the National Medical Products Administration.
On May 7, 2020, the State Food and Drug Administration accepted the application for consistency evaluation of bicalutamide tablets submitted by the company.
-
When will the world's top 10 pharmaceutical companies have China? Ten questions about the future of China's innovative drugs, devices, and vaccines
Time of Update: 2021-04-28
Over the past ten years, we have experienced drug review reform, 722 self-examination, medical insurance reform, the opening of the Hong Kong stock market 18A and the science and technology innovation board, a large number of scientists returned to China to start businesses, and a number of outstanding innovative drug companies grew up.
-
Nefecon, a new drug for primary IgA nephropathy, applies for listing in the United States!
Time of Update: 2021-04-28
The Swedish biopharmaceutical company Calliditas Therapeutics recently announced that it has submitted a new drug application (NDA) for Nefecon (budesonide) to the US Food and Drug Administration (FDA), a new oral formulation that targets down-regulation of IgA1 for the treatment of primary IgA.
-
The PI3Kδ inhibitors introduced by Cinda Biosystems are planned to be included in breakthrough treatment products
Time of Update: 2021-04-28
Source: Guanlan PharmaceuticalToday (March 22), the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China announced that the parsaclisib tablet jointly declared by Innovent and Incyte has been included in the proposed breakthrough treatment product, and the proposed indication is recurrent or Refractory follicular lymphoma.
-
New oral TYK2 inhibitor! Nuocheng Jianhua Class 1 New Drug Clinical Application Accepted
Time of Update: 2021-04-28
SourceGuanlan PharmaceuticalOn February 26, Nuocheng Jianhua announced that its new drug clinical trial application for its new Tyrosine Kinase 2 (TYK2) inhibitor ICP-332 has been accepted by the China National Medical Products Administration (NMPA).
-
Roche's Evrysdi is about to be approved for listing in the EU and has been under review in China
Time of Update: 2021-04-28
Roche recently announced that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review suggesting that Evrysdi (risdiplam) should be approved for the treatment of age ≥ 2 months and a clinical diagnosis of 1 Type 2 type/3 SMA or type 5q spinal muscular atrophy (SMA) with 1-4 copies of SMN2.
