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The gospel of epilepsy patients, Eisai Perampanel is about to expand the indication population in China
Time of Update: 2021-08-05
Subsequently, the drug was approved by the FDA as a monotherapy in July 2017 for the treatment of partial-onset epilepsy (with or without secondary generalized seizures) in epilepsy patients 12 years of age and older .
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Announcement on the implementation of the second batch of unique identification of medical devices
Time of Update: 2021-08-05
Uniquely identify database submission For medical devices produced from March 1, 2022, before they are marketed for sale, the registrant shall upload the product identification and related data of the smallest sales unit and higher-level packaging to the medical device unique identification database in accordance with relevant standards or specifications.
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The GlaxoSmithKline shingles vaccine Shingrix received a key US FDA approval!
Time of Update: 2021-08-05
In the European Union, Shingrix was approved in August 2020 for adults aged 18 and over who are at increased risk of shingles, 11 months ahead of the US FDA’s approval, but the COVID-19 pandemic disrupted the rollout plan.
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Qilu Pharmaceutical's new pancreatic cancer drug was approved for clinical use
Time of Update: 2021-08-05
The Center for Drug Evaluation (CDE) of the National Food and Drug Administration of China has announced that the CEND-1 for injection introduced by Qilu Pharmaceutical has obtained an implied license for a clinical trial and is intended to be developed for the first-line treatment of advanced metastatic pancreatic cancer .
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Sino-US double batch!
Time of Update: 2021-08-05
On July 27, Hengrui Medicine announced that its self-developed long-acting insulin/GLP-1 analog fixed-ratio compound preparation HR17031 injection has been approved for clinical use in China and is intended to be used for the treatment of type 2 diabetes .
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Borui Pharmaceuticals "Oseltamivir Capsules" Approved for Listing
Time of Update: 2021-08-05
Currently, according to the Insight database, Dongyang Sunshine has two dosage forms of oseltamivir capsules and granules, and has also submitted an application for the marketing of oseltamivir dry suspension, which is currently under review and approval; at the same time, it has also applied for sustained-release tablets.
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IND application for CD47/Her2 double antibody project was accepted by FDA
Time of Update: 2021-08-05
On July 28, ImmuneOnco announced that the world's first dual-target antibody-receptor recombinant protein drug targeting human CD47 x Her2 (IMM2902) has been accepted by the US FDA for a new drug clinical research application (IND) .
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New developments in potential "specific drugs" for new crowns: masitinib+S2H97
Time of Update: 2021-08-05
How to deal with the continuous evolution of the new coronavirus and develop neutralizing antibodies or new coronavirus vaccines that have a "broad-spectrum effect" and prevent the virus from escaping are important issues that researchers need to solve .
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A batch of pharmacy window advertisements are banned
Time of Update: 2021-08-05
It is understood that the Municipal Urban Management and Law Enforcement Bureau conducted a comprehensive survey of pharmacies in the central city, interviewed the heads of more than 50 chain enterprises in 453 pharmacies, urged themselves to clean up the indiscriminately posted advertisements in the stores, and signed a letter of commitment.
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To ensure that the three-child policy is effective, the National Health Commission puts forward six key tasks
Time of Update: 2021-08-05
Standard Standard Standard care health care Regarding the development of childcare services, the notice proposes to study and formulate a special plan for the development of childcare services during the 14th Five-Year Plan; implement the “14th Five-Year” public childcare service capacity building project and special actions for inclusive childcare services, and expand investment within the central budget , Support social forces to develop community nursery service facilities and comprehensive nursery service institutions .
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AstraZeneca/Daiichi Sankyo declares TROP 2 ADC
Time of Update: 2021-08-05
The development of DS-1062a for NSCLC is currently in phase III clinical phase, and a new phase I cohort study for HR+/HER2- breast cancer patients has also been opened .
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The State Food and Drug Administration released a catalog of generic drug reference preparations
Time of Update: 2021-08-05
After review and determination by the Expert Committee of the Quality and Efficacy Consistency Evaluation of Generic Drugs of the National Medical Products Administration, the catalogue of generic drug reference preparations (the 43rd batch) is now released .
Attachment: List of Generic Drug Reference Preparations (Forty-third batch)
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BMS withdraws Opdivo monotherapy for sorafenib treatment failure indication for hepatocellular carcinoma
Time of Update: 2021-08-05
However, in the confirmatory clinical trial CheckMate-459, Opdivo and Sorafenib head-to-head first-line treatment of patients with hepatocellular carcinoma in the pre-specified analysis, the primary endpoint of overall survival did not reach statistical significance .
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Nuocheng Jianhua SHP2 allosteric inhibitor submits clinical application
Time of Update: 2021-08-05
According to the press release, ICP-189 is mainly used to treat a variety of solid tumors.
It aims to provide new solid tumors such as lung cancer, head and neck cancer and gastrointestinal tumors Clinical treatment methods .
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The price of heavy and large varieties is reduced by more than 50%
Time of Update: 2021-08-05
On the same day, the Centralized Procurement Network of Medicines and Medical Consumables in Liaoning Province issued the "Notice on the Implementation of the Results of Active Price Reduction of Two Drugs including Dalley Tuumab Injection .
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Production shrinks, imports are blocked, and turmeric prices rise!
Time of Update: 2021-08-05
In recent years, due to the impact of foreign low-priced goods, the domestic authentic variety Chuan turmeric has suffered from low prices and shrinking planting areas, which has attracted market attention .
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The first single-dose option for pediatric ABSSSI!
Time of Update: 2021-08-05
The FDA approval is based on the results of a multi-center, open-label, positive-controlled clinical trial and 3 pharmacokinetic studies to evaluate the safety and effectiveness of dalbavancin in pediatric patients .
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The first IL-5 inhibitor to treat nasal polyps!
Time of Update: 2021-08-05
CompilenewbornThe GlaxoSmithKline (GSK) antibody drug Nucala is not the first biologic to be approved for the treatment of nasal polyps, but it is the first IL-5 inhibitor to break through this indication, thus defeating competing products.
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Explore the mystery of repeated successes in clinical research of PARP inhibitors for ovarian cancer
Time of Update: 2021-08-05
Compared with placebo, olaparib It can reduce the risk of disease progression or death by 70% (Figure 1), opening a new era of first-line maintenance therapy for newly diagnosed ovarian cancer with PARP inhibitors .
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The Qinghai Sea line medical insurance information platform helps solve the problem of "errands and time-consuming"
Time of Update: 2021-08-05
The relevant person in charge of the Qinghai Provincial Medical Security Bureau said that after the platform is launched, it will create more efficient, convenient, high-quality and safe medical insurance public service conditions for more than 5.
