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The seventh batch of national procurement applications involving 200+ enterprises has been launched!
Time of Update: 2022-03-02
The seventh batch of national procurement applications has been launched, involving a total of 208 medicines including afatinib oral regular-release dosage form and oseltamivir oral regular-release
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BeiGene's Zanubrutinib Approved in Switzerland for the Treatment of Waldenström's Macroglobulinemia
Time of Update: 2022-03-02
Recently, BeiGene announced that its BTK inhibitor Brukinsa (Chinese trade name: Baiyueze®, generic name: zanubrutinib, zanubrutinib) has been approved by Swissmedic: for the treatment of Adult patients with Waldenström macroglobulinemia (WM) .
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CDE publishes "Technical Guidelines for Clinical Pharmacology Research of Biosimilars"
Time of Update: 2022-03-02
Clinical pharmacology research is an important part of the comparison study of biosimilars, and it is very important to support the similarity evaluation of the efficacy and safety of biosimilars and reference drugs .
Attachment: Technical Guidelines for Clinical Pharmacology Research of Biosimilars.
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On February 18, these pharmaceutical companies issued announcements related to personnel changes, mergers and acquisitions, etc.
Time of Update: 2022-03-02
Microchip Bio: The application for the issuance of convertible bonds to unspecified objects passed the microchip bio announcement that the Shanghai Stock Exchange Science and Technology Innovation Board Listing Committee held the ninth listing committee review meeting in 2022 on February 17, 2022.
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To empower local innovation, multinational pharmaceutical companies are accelerating their cooperation with local companies
Time of Update: 2022-03-02
In addition to Roche Diagnostics, in fact, in recent years, the "wave of cooperation" between domestic and foreign pharmaceutical companies has begun to emerge .
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CDE Publishes Guidelines for Mixing Uniformity and Intermediate Control Dose Uniformity of Chemical Drug Solid Preparations
Time of Update: 2022-03-02
This research strategy is expected to provide a reference for the research on the uniformity of mixing and the uniformity of the medium-controlled dosage unit in the process of drug development and production .
Attachment: Technical Guiding Principles for Research on Mixing Uniformity and Intermediate Controlled Dose Unit Uniformity of Chemical Oral Solid Preparations (Trial).
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What is the impact of the newly promulgated new crown clinical guidelines in China on the research and development of new crown drugs?
Time of Update: 2022-03-02
Not long before the release of this guideline, CDE approved Pfizer's new crown specific drug "Paxlovid", an oral small molecule new crown virus treatment drug, for the treatment of adult patients with Mild to moderate novel coronavirus pneumonia (COVID-19) patients with high risk factors for progression to severe disease .
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The purchase of 324 drugs was suspended without price adjustment!
Time of Update: 2022-03-02
In August 2021, the Shanxi Provincial Pharmaceutical Equipment Centralized Bidding Procurement Network issued the "Notice on Carrying out Standardized Platform Chemical Drugs Online Purchasing", requiring the original research drugs and reference preparations with the same generic name and dosage form to be listed at the national provincial lowest price.
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Annual performance PK of multinational pharmaceutical companies!
Time of Update: 2022-03-02
0 1 Pfizer: New crown vaccine + oral drugs drive performance soaring Pfizer's 2021 sales are expected to exceed $80 billion, the highest annual number ever, Chief Executive Officer Albert Bourla said .
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The most noteworthy blockbuster new drug trial results in 2022!
Time of Update: 2022-03-02
Menarini and Radius reported top-line data from a Phase III trial of the collaborative development of elacestrant in October 2021, with marketing applications to be submitted in the U.
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The 2nd paragraph in the country!
Time of Update: 2022-02-25
Article source: Medical Cube InfoOn November 29, Junshi Bio announced that the clinical trial application for Aurora A inhibitor WJ05129 tablets (JS112) of Suzhou Junjing Bio (which jointly invested with Weijing Bio) has been accepted by NMPA .
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Henlius Chairman Chen Qiyu resigned and Zhang Wenjie took over
Time of Update: 2022-02-25
On November 30, Henlius announced that Chen Qiyu had resigned as the chairman of the company due to work arrangement adjustments.
Chen Qiyu will still serve as a non-executive director of Henlius .
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FDA Approves Innovative Imaging Drug to Help Surgeons "Illuminate" Tumors
Time of Update: 2022-02-25
S. Food and Drug Administration (FDA) has approved its targeted fluorescent imaging agent Cytalux (pafolacianine) for the detection of malignant lesions during ovarian cancer surgery, allowing doctors to remove more tumors .
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Clinical trial of Garcos KRAS G12C inhibitor in combination with cetuximab approved in China
Time of Update: 2022-02-24
Garcos to initiate a Phase I/II, open-label, multicenter, dose-escalation and expansion clinical study in China to explore the safety of JAB-21822 in combination with cetuximab in patients with KRAS G12C-mutated advanced colorectal cancer Sex, tolerability and preliminary efficacy .
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The first self-developed inflammatory immune drug!
Time of Update: 2022-02-24
Article source: Medical Cube InfoAuthor: sunshineOn December 8, the CDE official website showed that the application for the clinical trial of BeiGene’s TYK2 allosteric inhibitor BGB-23339 was accepted .
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Bad test data!
Time of Update: 2022-02-24
Despite many setbacks in both trials and collaborations, Mesoblast said it remains determined to bring the cell therapy remestemcel-L to market for patients with acute respiratory distress syndrome (ARDS) caused by COVID-19 .
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Kangchen Pharmaceutical's clinical application for the import of teriparatide similar drugs has been accepted
Time of Update: 2022-02-24
Osteoporosis with high fracture risk is a rare drug on the market that promotes bone formation for the treatment of osteoporosis .
Kangchen Pharmaceutical is a company that produces the same teriparatide biosimilar in the same water injection pen formulation as Lilly’s original research.
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Fexofenadine Hydrochloride Tablets, a subsidiary of Hengrui Medicine, passed the consistency evaluation of generic drugs
Time of Update: 2022-02-24
61 million yuan has been invested in research and development of fexofenadine hydrochloride tablets in the generic drug consistency evaluation project .
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Zhang Bin, chairman of Guangyuyuan, resigned and Ju Zhen took over
Time of Update: 2022-02-24
On December 6, Guangyuyuan announced that the company received a written resignation report submitted by Chairman Zhang Bin .
The meeting elected Ju Zhen as the chairman of the 7th board of directors of the company.
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3SBio's new anti-pruritic drug TRK-820 is declared for listing
Time of Update: 2022-02-24
The trial was designed to evaluate the efficacy and safety of nalvuraphine hydrochloride orally disintegrating tablets in the treatment of refractory pruritus in patients with chronic renal failure on maintenance hemodialysis, and to bridge the efficacy data from Japan .
