[April 30, 2021/List of medical information] FDA review mechanism is stepped up! Acceleron was warned for not releasing the test data in time; Roche atelizumab was approved in China for the first-line treatment of non-small cell lung cancer; Takeda Gaucher's new drug for injection of Verazilase alpha was approved in China; the price was reduced by 77%. Enterprise products are bargained...Daily fresh medicines, and medical news, speed reading and you will pay attention to it together!
- Part 1 Policy Brief
Medical Insurance Catalog Negotiation Drug Admission Difficulty Is Expected to Be Solved
The National Medical Insurance Administration held a press conference for the reference list (first batch) of some negotiating drug allocation institutions for the new access to the National Medical Insurance Catalog in 2020. To facilitate the timely purchase of drugs for the national medical insurance negotiations, the National Medical Insurance Bureau organized experts to screen the first batch of 19 drugs with urgent clinical needs and not strong substitutes from the newly negotiated drugs in 2020. The information of designated medical institutions and designated retail pharmacies that have been equipped with the first batch of 19 medical insurance catalog negotiation drugs can be inquired by the public through the National Medical Insurance Service Platform (APP). (National Medical Insurance Administration)
National Food and Drug Administration: Effectively strengthen the strict supervision of online drug sales
On the 29th, the State Food and Drug Administration organized a symposium on drug online sales supervision in Shanghai. The meeting emphasized that online drug sales are a prerequisite for ensuring the safety and effectiveness of drugs. It is necessary to improve support systems, clarify the responsibilities of all parties, give full play to the joint efforts of departments, strengthen supervision and law enforcement, and effectively strengthen the strict supervision of online drug sales. The meeting required that drug online sellers must strictly follow the "Drug Administration Law" and other laws and regulations, consolidate the main responsibility of drug online sales, and ensure continuous compliance throughout the entire operation. (National Food and Drug Administration)
Price cut 77%, well-known machinery company products are bargained
Recently, the Nanjing Medical Insurance Bureau's official WeChat account announced that the Centralized Procurement Alliance Office of Medical Consumables of Designated Medical Institutions in Nanjing has launched the "10·30" product continuation negotiations. The three types of products of newly-selected enterprises dropped an average of 49.47%, and the highest drop as central venous catheters (single_lumen), which reached 77%; based on the substantial price cuts of "10·30", the products of the originally selected enterprises achieved an increase of 5.53%. Average drop. Estimated annual savings of 18.1 million yuan. (Nanjing Medical Insurance Bureau)
Another round of "big chaos" among pharmaceutical companies is coming, involving 53 varieties
The industry has circulated a notification on the new round of volume procurement by Chongqing and other 11 provinces and regions. In this "Chongqing, Henan, Hubei, Xianggui, Qiongyun, Qingning, Xinxin Xinjiang Corps on reporting the volume of drugs in the alliance provinces (cities, districts) In the "Notice of Procurement Related Data", 53 varieties were included in the reporting list, including papaverine, felodipine, pravastatin, urapidil, and other varieties. (Medicine Representative)
- Part 2 Observation of Sankei
Zhou Jie, director, and general manager of First Pharmaceutical, resigns
Shanghai First Pharmaceutical issued an announcement stating that the board of directors had recently received a resignation report from the company's director, and general manager Zhou Jie. Due to personal reasons, Zhou Jie requested to resign as a director of the company's ninth board of directors, a member of the strategic committee of the board of directors, and the general manager. (a)
- Part 3 Drug News
The FDA review mechanism is stepped up! Acceleron warned for not releasing test data in time
A few days ago, the US FDA issued a severe non-compliance notice to Acceleron Pharma. The FDA alleges that the company failed to publish summary data on its cancer combination dalantercept and axitinib phase 2 trials in an online database on the ClinicalTrials.gov website. The FDA warned that if Acceleron fails to publish the test results on the website within 30 days, it will impose a fine of $10,000 or prosecute it. (Sina Pharmaceutical News)
The first domestic temporary cardiac pacemaker approved for listing
According to the official website of the State Food and Drug Administration, the first domestic temporary cardiac pacemaker was approved for the market. This product is an innovative product produced by Shenzhen Xianjian Xinkang Medical Electronics Co., Ltd. The product consists of a non-implantable pulse generator and a patient cable. It is suitable for external temporary pacing of the atrium or ventricle; it is also suitable for analyzing the pacing electrode system during the implantation of pacemakers and defibrillators. (National Food and Drug Administration)
Baiyang Nifedipine Controlled_Release Tablets Approved
Qingdao Baiyang Pharmaceutical, a subsidiary of Baiyang Pharmaceutical Group, announced that the company's self-developed controlled-release nifedipine tablets have been formally approved by the NMPA. It is reported that the new product adopts advanced double-layer push-pull osmotic pump preparation technology, which can bring patients a new choice of long-term, stable, once-a-day medication. (a)
Indonesia approves emergency use of Chinese new crown vaccine
On the morning of April 30, local time, Penny Lukito, head of the Indonesian National Medical Administration, announced the emergency use of the new crown vaccine produced by Sinopharm. (Associated Finance Press)
Roche atelizumab approved as first-line treatment for non-small cell lung cancer in China
According to the NMPA drug approval website, Roche's PD-L1 antibody atelizumab (trade name: Tecentriq, Santec) has obtained the drug approval number. In September 2020, the drug's application for monotherapy for the first-line treatment of PD-L1-positive and EGFR/ALK-negative metastatic non-small cell lung cancer patients was included in the priority review by NMPA. The acceptance number associated with the approval number obtained this time is the same as the acceptance number included in the priority review in September last year, which means that this drug is officially approved in China for the first-line treatment of patients with metastatic non-small cell lung cancer! (Immediately smell the medicine)
Takeda Gaucher's new drug for injection verasiase alpha is approved in China
NMPA publicity shows that the Velaglucerase Alfa (velaglucerase alfa) for injection of the Shire, a subsidiary of Takeda, has been approved for listing. According to public information, the approved indication for the drug this time is Gaucher disease. Public information shows that Veracilase Alpha for injection is hydrolysing lysosomal-specific glucocerebrosidase, which is designed to replace glucocerebrosidase lacking in patients with type 1 Gaucher disease. It has The same amino acid sequence as the enzymes naturally produced in the body. (WuXi AppTec)
Vertex's KAFTRIO and ivacaftor are approved in the EU for the treatment of cystic fibrosis
Vertex Pharmaceuticals announced that the European Commission has approved the combination of KAFTRIO® (ivacaftor/tezacaftor/elexacaftor) and ivacaftor for the treatment of cystic fibrosis (CF) aged 12 years and over and the CF transmembrane conductance regulator (CFTR) gene has at least one F508del Label expansion for patients with mutations. (Sina Pharmaceutical News)
The median survival time has doubled! The latest results of pancreatic cancer combination therapy are gratifying
Galera Therapeutics announced that the investigational therapy GC4419 has achieved positive results in a phase 1/2 clinical trial for the treatment of patients with locally advanced pancreatic cancer. The test results showed that GC4419 combined with stereotactic radiotherapy (SBRT), compared with SBRT, increased the patient's median overall survival (OS) by nearly double! (WuXi AppTec)
Luye Pharmaceutical's innovative compound liposome formulation completes the first patient enrollment in Phase I clinical trials
Luye Pharmaceutical Group announced that its self-developed anti-tumor innovative preparation, irinotecan hydrochloride liposome injection (LY01616), has completed the first patient enrollment in phase I clinical trials. This clinical study is a multi-center, open, dose-escalating, single and multiple-dose phase I/II clinical study, which aims to evaluate the safety, tolerability, and PK characteristics of LY01616 in patients with advanced gastrointestinal tumors And preliminary clinical efficacy. (PR Newswire)
Renfu Medicine HW021199 tablets were approved for clinical use in the treatment of idiopathic pulmonary fibrosis
Renfu Medicine issued an announcement stating that recently, its subsidiary Hubei Biomedical Industry Technology Research Institute Co., Ltd. received the "Notice of Drug Clinical Trial Approval" for HW021199 tablets approved and issued by the National Medical Products Administration. HW021199 tablets are suitable for the treatment of idiopathic pulmonary fibrosis. At present, there is no drug with the same target on the market globally. Only two drugs, nintedanib, and pirfenidone, are approved for the treatment of idiopathic pulmonary fibrosis. (a)
Lansoprazole for injection of cucurbitwa obtained the drug registration certificate
Huluwa announced that it had recently received the "Drug Registration Certificate" for lansoprazole for injection approved and issued by the State Food and Drug Administration. The listing application was accepted by the Hainan Provincial Drug Administration in 2015. Up to now, Huluwa has invested a total of RMB 4,999,300 in research and development expenses for this product (unaudited). This product is intended to be used for gastric, duodenal ulcers, acute stress ulcers, and acute gastric mucosal injuries with bleeding that are not suitable for oral therapy. (a)
Kelun's 2 injections have been reviewed! 10 varieties are planned to enter the fifth batch of centralized procurement
The official website of NMPA shows that Kelun Pharmaceutical's ceftazidime for injection, medium, and long_chain fat emulsion/amino acid (16)/glucose (16%) injection passed the consistency evaluation. Ceftazidime for injection is the fifth batch of varieties to be collected. At present, Kelun Pharmaceutical has 10 over-evaluated varieties into the fifth batch of collected reports. (Minenet)
East Sunshine Medicine is out! 3 heavy varieties are coming
The aripiprazole orally disintegrating tablets, febuxostat tablets, and rivaroxaban tablets reported by Dongyang Pharmaceutical under the new registration classification have entered the administrative examination and approval stage and will be approved soon. According to data from Menet.com, aripiprazole, febuxostat and rivaroxaban are all one-billion-dollar species in the domestic market, and rivaroxaban is the fifth batch of species to be harvested, and 17 companies have been reviewed. . (Minenet)
Evidence that reduces the risk of family infection by nearly 50%, the new crown vaccine prevents the spread of the virus
A few days ago, a new study published by the Department of Public Health of the United Kingdom showed that three weeks after receiving a dose of the new crown vaccine, even if the vaccinated person is infected with the new crown virus again, their risk of transmitting the new crown virus to family members will be reduced by about 40-50 %. (WuXi AppTec)
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