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FDA updates draft facility communication guidance for pre-filing applications for priority review of generic drugs
Time of Update: 2023-01-01
The guide also includes a Q&A section that addresses questions about PFC FAQs. The US FDA was released on December 2 Draft guidance entitled "ANDA: Pre-Nomination Facility Communication Related to Priority Generic Drug Submissions" was released, containing generic program enhancements related to the content, timing and evaluation of Pre-Nomination Facility Communications (PFC) in the Simplified New Drug Application (ANDA) review program, which is the Generic User Fee Amendment Reauthorization (GDUFA).
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Why do tumor patients have pathological fractures? How can it be prevented
Time of Update: 2022-10-02
What should I do if I have a pathological fracture?After the occurrence of pathological fractures, it is necessary to seek medical attention in time, and when moving the affected limb, it is necessary to properly support and avoid the displacement of the fracture end.
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Financing and Payment of Innovative Drugs: How to reach a consensus among medical/insurance/medicine/patient parties
Time of Update: 2022-06-13
Abstract: Applying stakeholder theory, analyzes the relationship between patients, medical insurers, medical providers, and drug manufacturers in the field of innovative drug financing and their resp
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This pharmaceutical company has 3 new Class 1 drugs that are about to be launched, and the Nuggets ADC track
Time of Update: 2022-04-23
In addition, Rongchang Bio has 4 new class 1 drugs that have entered the clinical trial stage (excluding new drugs that have been marketed to develop new indications), namely RC88, RC98, RC108 and RC118, all of which are in the clinical phase I stage .
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Jiahe Biologics STING agonist GB492 clinical trial application accepted
Time of Update: 2021-04-14
It is understood that a number of previous studies have shown that interferon gene stimulating factor (STING) agonists can be used in combination with immune checkpoint inhibitors (ICI) as a new immunostimulatory therapy that can enhance the efficacy of cancer immunotherapy.
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Domestic innovative drugs are accelerating the embrace of the international market of the sea of stars
Time of Update: 2021-03-05
For example, on January 12th Baiji Shenzhou announced a cooperation and licensing agreement with pharmaceutical giant Novarce for the development, production and commercialization of its self-developed anti-PD-1 antibody drug, Reilly Pearl Monoanti, in several countries.
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The National Institutes of Health (NIH) conducted a study to assess the safety of Redsiway in COVID-19 pregnancy patients
Time of Update: 2021-02-24
A new study funded by the National Institutes of Health (NIH) will assess the effects of remdesivir on COVID-19 pregnant women.
study, called IMPAACT 2032, will be conducted by the International Network of Clinical Trials on Maternal, Child and Adolescent AIDS (IMPAACT) funded by the National Institutes of Health (NIH).
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Just another commonly used drug completely discontinued, banned from sale
Time of Update: 2021-01-31
phenolic tablets and phenolic tablets that have been listed for sale shall be recalled by the manufacturing enterprise, and the recalled products shall be supervised and destroyed by the drug regulatory department where the enterprise is located.
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East Sunshine Medicine took 1.5 billion varieties of 24 new products on the way
Time of Update: 2021-01-08
tu: Tigrello film evaluation source: Mi net consistency evaluation database including East Sunshine medicine, there are currently 9 domestic enterprises for Grelo tablets approved production and as reviewed, including Yangzijiang, Zhengda Tianqing, Xinlitai, stone medicine and so on.
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Home-made PD-1 therapy! Baiji Shenzhou Baizean ® (for Reilly zhu single resistance) treatment of non-small cell lung cancer Phase 3 clinical success
Time of Update: 2020-11-28
November 18, 2020 // -- BeiGene recently announced the evaluation of the anti-PD-1 antibody drug Bazean ® (Tislelizumab, Terelli Phase 3 RATIONALE 303 study (NCT03358875) for the treatment of non-small cell lung cancer (NSCLC) reached the primary endpoint of total lifetime (OS) during the medium-term analysis.
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26 batches of drugs found to be ineligible (with list
Time of Update: 2020-11-15
, according to the notice, of the 26 batches of non-conforming drugs, 13 batches were rice buds, and the non-conforming items were all inspected.
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Shanghai Pharmaceutical Injection LT3001 will soon start Phase I clinical trials
Time of Update: 2020-11-14
September 10, Shanghai Pharmaceuticals announced that the company's "injection LT3001" recently obtained the approval of the State Drug Administration issued the "Drug Clinical Trial Approval Notice", and will soon start Phase I clinical trials.
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Henrui Pharmaceuticals' nectic acid famini capsules have been approved for clinical trials
Time of Update: 2020-10-15
Specifically as follows: Drug Name: Apple acid Famini Capsule Dosage Form: Capsule Application: Clinical Trial Acceptance Number: CXHL2000271, CXHL2000272, CXHL2000273 Approval Conclusion: In accordance with the Drug Administration Law of the People's Republic of China and the relevant provisions, upon examination, the apple acid famini capsules accepted on June 10, 2020 met the relevant requirements for drug registration and agreed to conduct clinical trials of advanced gastrointestinal mesothelioma that failed to be treated with imatini.
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The U.S. Pharmacopeia identifies 15 priorities for the next five years
Time of Update: 2020-09-27
He also described USP's achievements in working with the FDA over the past five years, including creating a pending monograph program, bringing together stakeholders to help mitigate opioid misuse and abuse through labeling and packaging standards, prioritizing quality standards for OTC drugs, such as products containing acetaminophen and testing for key impurities, and supporting the FDA's Drug Competition Action Plan (DCAP).
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Sequoia and Sequoia are betting on whether the neural intervention track can replicate the success of cardiovascular intervention
Time of Update: 2020-09-08
's first-tier market data can support his feelings, according to the arterial orange database financing data, in June-August this year, three months, the field of neural intervention intensive six financing, of which five financing amounted to 100 million yuan, investment institutions including Gao wei capital, Sequoia China, CITIC Medical Fund and other well-known investment institutions.
