-
Sanofi/Regeneron's anti-Libtayo treatment of advanced BCC approved by Health Canada
Time of Update: 2021-12-09
Sanofi recently announced that the anti-PD-1 therapy Libtayo (cemiplimab) developed with its partner Regeneron has been approved by Health Canada as a monotherapy for the treatment of receiving a hedgehog pathway inhibitor ( HHI) Adult patients with locally advanced or metastatic basal cell carcinoma (BCC) who have been treated but have progressed or are intolerant to such drugs .
-
Qilu Pharmaceutical declares the world's first generic drug ``Olapali''
Time of Update: 2021-12-09
According to NextPharma, the medical Rubik’s Cube database, there are currently 6 PARP inhibitors on the market worldwide, namely olaparib (AstraZeneca/Mersk), Nirapali (GSK/Zai Lab), and Lucapali (Clovis).
At present, 4 innovative PARP inhibitor drugs have been approved for marketing in China, namely olaparib, niraparib, fluzoparib, and pamiparib .
-
Zhao Junning is appointed Deputy Director of the State Drug Administration
Time of Update: 2021-12-09
Among them, Zhao Junning was appointed as the deputy director of the State Drug Administration .
In October 2021, he was appointed Deputy Director of the State Drug Administration .
-
Merck's oral new crown drug molnupiravir approved
Time of Update: 2021-12-09
Molnupiravir is the world's first oral antiviral drug approved for the treatment of mild to moderate COVID-19 in adults .
-
Ji'ankang's core product for bile duct cancer drug obtained FDA fast track qualification
Time of Update: 2021-12-09
ArticleMedicine GuanlanOn October 27th, Yaojieankang announced that the US FDA has granted the company's core product TT-00420 fast track qualification for the treatment of cholangiocarcinoma (CCA) patients without standard treatment options .
-
Keep the people's "medical money" and "life-saving money" well, Xinjiang hires 48 social supervisors of the medical insurance fund
Time of Update: 2021-12-09
Wang Zhihua said that the selection of the Xinjiang Medical Insurance Fund to supervise social supervisors is a new measure taken by the Xinjiang Medical Insurance Bureau to understand and listen to the people’s opinions.
-
Hengrui Class 1 antifungal drug Phase III clinical success plans to be listed in the near future
Time of Update: 2021-12-09
A randomized, double-blind double-simulation, fluconazole parallel controlled, multi-center phase III clinical study (SHR8008-302) The main research endpoint results reached the pre-specified superiority standard .
-
CDE solicits opinions on relevant regulations on drug review timing management
Time of Update: 2021-12-09
According to the draft for comments, the six situations for the suspension of timing operations are: disapproval of publicity and dissent from the review conclusion; waiting for the company to reply and issue supplementary materials; waiting for an expert consultation meeting, etc.
-
11 charts at a glance
Time of Update: 2021-12-09
Table 5: Three types of innovative devices approved for marketing in October 2021Source: National Medical Device Evaluation CenterAs of November 3, 2021, in October 2021, the State Administration has approved a total of 85 third-class medical device products for the first registration, of which 69 are domestically produced and 16 are imported .
-
Boehringer Ingelheim and Thoeris collaborate on new treatments for urea cycle disorders
Time of Update: 2021-12-09
Boehringer Ingelheim will start a new collaboration with Thoeris to advance the first-of-its-kind therapy for the treatment of urea cycle disorders (UCD), regardless of the underlying single-gene cause.
-
Pay attention to the "fourth highest" high uric acid medication pattern inventory
Time of Update: 2021-12-09
. Market scale of anti-gout drugs in Shanghai hospital market from January 2020 to August 2021 (unit: ten thousand yuan)At present, anti-gout drugs mainly include five drugs: febuxostat, benzbromarone, Qingpeng ointment, allopurinol and colchicine .
-
Supervising the National Medical Insurance Bureau to notify that such medical devices will be discontinued
Time of Update: 2021-12-09
In September of this year, the State Food and Drug Administration, the National Health Commission, and the National Medical Insurance Bureau jointly issued the "Announcement on Doing a Good Job in the Implementation of the Second Batch of Unique Identification of Medical Devices .
-
Bayer joins hands with Jointown to empower self-care and continue to expand the accessibility of health products
Time of Update: 2021-12-09
Both parties agreed to expand the breadth and depth of existing cooperation, and deepen cooperation in areas such as enriching product categories, improving product accessibility, and carrying out self-health science education and publicity, so as to provide consumers with richer self-health solutions to meet diversified needs.
-
Yang Sen submits an application for HIV therapy rilpivirin injection in China
Time of Update: 2021-12-09
In 2017, Rilpivirin tablets were approved for marketing in China and are suitable for newly-treated patients with HIV-1 infection with human immunodeficiency virus type 1 ribonucleic acid (HIV-1 RNA) less than or equal to 100,000 copies/mL at the beginning of treatment (12 years old and above) .
-
Lepu Bio-Putlizumab plans to be included in the priority review for the treatment of MSI-H/dMMR advanced solid tumors
Time of Update: 2021-12-09
On October 28th, the CDE official website revealed that Lepu Biologic’s Pucotenlimab injection (pucotenlimab, HX008) is planned to be included in the priority review for the treatment of highly unstable microsatellites ( Patients with advanced solid tumors with MSI-H) or defective mismatch repair (dMMR) .
-
New indication for Sanofi's non-calcium-phosphorus-containing binding agent Novila (R) was launched
Time of Update: 2021-12-09
Shanghai, November 2, 2021/PRNewswire/ - Recently, Sanofi, the world's leading biopharmaceutical company, announced that Novila® (sevelamer carbonate) was officially listed in China for a new indication for treatment that has not been carried out Hyperphosphatemia in adults with chronic kidney disease on dialysis .
-
AstraZeneca and Inovio terminate 6-year DNA cancer vaccine collaboration
Time of Update: 2021-12-09
In a document published by the US Securities Exchange, Inovio announced that AstraZeneca's Medimmune Limited has terminated the development plan of INO-3112, which is a vaccine candidate called MEDI0457 .
-
Siddi declares CD47 monoclonal antibody
Time of Update: 2021-12-09
On November 2nd, CDE accepted the clinical trial application for the CD47 monoclonal antibody drug 3D197 .
This application is the first phase I clinical trial of 3D197 in China.
-
Pfizer sells mid-term TYK2 inflammation drugs or withdraws from competition with Bristol-Myers Squibb
Time of Update: 2021-12-09
After studying a large number of leading inhibitors of inflammatory diseases, Pfizer recently announced that it is preparing to sell its investment portfolio to a new company in exchange for a 25% stake in the startup .
-
Heji Pharmaceutical-the world's first ITK inhibitor IND to enter the clinical stage received clinical trial approval
Time of Update: 2021-12-09
S. October 26, 2021/PRNewswire/ - Heji Pharmaceuticals announced that its first ITK inhibitor in the world to enter the clinical development stage, the clinical use of CPI-818 for oral administration The trial application was approved by the NMPA Drug Approval Center for clinical trial approval, and it is intended to be used for relapsed/refractory T-cell lymphoma .
