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New rules for marketing authorization holders open for comments! There are special requirements for the audit of pharmaceutical packaging material suppliers and the post-marketing change control
Time of Update: 2022-12-30
In addition, Article 23 [Requirements for Drug Safety Incidents] stipulates that in the event of a safety incident related to drug quality, the holder shall immediately take effective measures to dispose of the relevant drugs and their raw materials, excipients, packaging materials and containers and relevant production lines that directly contact drugs, so as to prevent the harm from expanding.
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Professor Zhou Caicun: Serplulimab has been approved as a first-line indication for lung squamous cell carcinoma, and two high-level international studies have led PD-1 inhibitors
Time of Update: 2022-11-15
On November 1, the innovative PD-1 inhibitor sylplulimab (trade name: Hans-form ®) combined with chemotherapy (carboplatin and albumin paclitaxel) independently developed by China was approved for the
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Frequent random inspections in various places, and a large number of drug quality problems have been exposed
Time of Update: 2022-11-04
In addition to Guangdong, the Anhui Provincial Food and Drug Administration also issued a notice on drug production supervision and inspection information on the 27th.
In addition to Guangdong, the Anhui Provincial Food and Drug Administration also issued a notice on drug production supervision and inspection information on the 27th.
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Seagen and Sanofi reach cooperation to develop multiple anti-cancer ADCs
Time of Update: 2022-05-27
On March 16, 2022, Seagen and Sanofi announced an exclusive collaboration agreement to design, develop and commercialize antibody drug conjugates (ADCs) against up to three cancer targets .
References:[1] Seagen and Sanofi Announce Collaboration to Develop and Commercialize Multiple Novel Antibody-Drug Conjugates.
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The blockbuster centralized procurement alliance has landed, and the bid will be opened one month later
Time of Update: 2022-02-16
According to the document, the centralized procurement of drugs by the Yangtze River Delta Alliance involves 47 drugs including atorvastatin, entecavir, paroxetine, imatinib, and dapoxetine, all of which are domestically sourced .
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The State Food and Drug Administration released the catalogue of the 50th batch of generic drug reference preparations
Time of Update: 2022-01-25
It involves 70 kinds of medicines , including alfacalcidol drops, sodium citrate hemofiltration replacement fluid, and propranolol hydrochloride sustained-release capsules .
It involves 70 kinds of medicines , including alfacalcidol drops, sodium citrate hemofiltration replacement fluid, and propranolol hydrochloride sustained-release capsules .
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my country's first anti-coronavirus specific drug is approved to be marketed and effective immediately after infusion
Time of Update: 2022-01-11
It was learned on December 20 that China's first anti-new coronavirus specific drug was approved by the China Food and Drug Administration .
The professor of the R&D team explained the principle of the anti-coronavirus specific drug: antibodies are the human body's natural weapon.
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Pfizer's oral JAK inhibitor Xeljanz receives two new indications in the EU
Time of Update: 2021-11-05
CompilationTom LeeA few days ago, the European Commission (EC) announced the approval of Pfizer’s JAK inhibitor oral drug Xeljanz (tofacitinib) for the treatment of young children with active polyarticular joints who are two years of age and older who have first used anti-rheumatic drugs (DMARDs) and have poor response to treatment.
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incredible! The unprecedented complex appearance of living bacteria
Time of Update: 2021-11-01
This research was published today (October 25, 2021) in "PNAS" and was completed in collaboration with scientists from the National Physical Laboratory, King's College London, Oxford University and Princeton University, revealing the bacteria with a protective layer- Gram-negative bacteria-there may be stronger spots and weaker spots on the surface .
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The patient has high fever and is resistant to cephalosporin
Time of Update: 2021-06-11
Only for medical professionals to read and refer to Enterobacter cloacae infection, how to choose the right antibacterial drug?
After the treatment, drug resistance of Enterobacter cloacae was detected in the abdominal drainage fluid, and the drug sensitivity result is shown in Figure 1.
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The regulations for the confidential management of drug review and approval information have been issued
Time of Update: 2021-02-07
The Regulations specify that the following four types of information fall within the scope of confidentiality: information submitted by applicants during the review and approval phase, production processes, key technical parameters, know-how, test data, etc.
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The "love" between man and pharmacy spanning thousands of years
Time of Update: 2021-02-01
Love: Modern- Pharmaceuticals entered a new era In the 10th century, drug development experienced three leaps 10 years later in the 100 years, the industrial era has also brought about a leap forward in technology in various fields, clinical began to enter the era of biopharmaceuticals.
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15 categories of equipment reduced category, another 13 categories of catalog content adjustment
Time of Update: 2021-01-14
If renewal is required, the registrar shall apply to the corresponding drug regulatory department for renewal of registration in accordance with the changed category six months before the expiration of the validity period of the medical device registration certificate, and if the renewal registration is granted, the medical device registration certificate shall be issued in accordance with the adjusted product management category.
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Adamo monobial-like drug Handa is ® in China
Time of Update: 2021-01-11
On December 26, 2020, Wanbang Pharma, a subsidiary of Shanghai Fosun Pharma (Group) Co., Ltd., officially announced that the Adamo single anti-injection (commodity name: Handayuan®) developed and pro
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A major breakthrough in first-line treatment of liver cancer! Roche's cancer immunization programme Tecentriq and Avastin (Tai Sanqi and Avetin) is about to be approved by the European Union
Time of Update: 2020-10-06
!--, 22 September 2020 // -- Roche has announced that the European Medicines Agency (EMA) Commission on Human Pharmaceutical Products (CHMP) has issued a positive review recommending approval of anti-PD-L1 therapy Te Centriq (Tai Sanqi, generic name: atezolizumab, atilijutatin monoanti) in a joint Avastin (Avistin, generic name: bevacizumab, beva bevajuumab) is used to treat adult patients with non-excisive or metastatic hepatocellular carcinoma (HCC) who have not been systematically treated in the past.
