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1 billion injections! Qilu Pharmaceutical's ibandronate sodium injection was approved and reviewed
Time of Update: 2021-08-14
Medical Network, August 9 News On August 5, the official website of the State Food and Drug Administration showed that Qilu Pharmaceutical's ibandronate sodium injection was approved as a supplementary application and became the second company to have reviewed the product .
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Jianyou shares this year's 10th ANDA approval involving 9 products are injections
Time of Update: 2021-08-14
Source: Mi Nei. com database, announcement of listed companies Medical Network, August 6 News On August 4, Jianyou shares announced that the company's subsidiary Hong Kong Jianyou recently received an ANDA approval notice for carmustine for injection issued by the FDA (application number 213460) .
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Regeneron/Sanofi Libtayo+ chemotherapy first-line treatment of advanced lung cancer phase 3 clinical trial success
Time of Update: 2021-08-14
On August 5, Sanofi and Regeneron announced that the key phase 3 study evaluating PD-1 tumor immunotherapy Libtayo combined with chemotherapy for the first-line treatment of advanced lung cancer was terminated early due to the very significant efficacy in the initial analysis .
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Confirmatory Phase III clinical trial failure BMS voluntarily withdraws Istodax PTCL indication
Time of Update: 2021-08-14
Recently, Bristol-Myers Squibb (BMS) has missed the primary endpoint of progression-free survival in a confirmatory phase III clinical trial and announced that it has withdrawn Istodax (Romidepsin) from the US market for the treatment of peripheral T-cell lymph.
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Yuekang Pharmaceutical: Zhu Li, the company’s core technical staff, leaves and Yang Lei takes over
Time of Update: 2021-08-14
Zhu Li, the company's core technical staff, would no longer hold any position in the company due to personal reasons .
Zhu Li holds the position of deputy general manager of the company's R&D center.
Zhu Li's resignation, the R&D work she was responsible for was handed over to Mr.
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Bayer's P2X3 receptor antagonist eliapixant in the treatment of RCC phase 2 clinical reached the efficacy endpoint
Time of Update: 2021-08-14
This is an international, placebo-controlled, randomized, double-blind, parallel group, dose discovery study to evaluate the treatment refractory of the oral potent and selective P2X3 receptor antagonist eliapixant (BAY1817080) compared with placebo Efficacy and safety of patients with chronic cough (RCC) .
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Another clinical trial of Amgen's BiTE therapy has been suspended!
Time of Update: 2021-08-14
At present, Amgen has stopped recruiting new patients with acute myeloid leukemia in its phase 1 clinical trial of BiTE therapy AMG427, which is aimed at the prolonged half-life of the antigen FLT3 .
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Sword refers to the space of 3 billion US dollars!
Time of Update: 2021-08-14
APG-2575 is a new type of oral Bcl-2 small molecule inhibitor, which restores the apoptosis mechanism of tumor cells by selectively inhibiting Bcl-2 protein, thereby killing tumors .
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Size doesn't matter: It is difficult to evaluate the efficacy of anticancer drugs when the tumor shrinks
Time of Update: 2021-08-14
Although our understanding of the molecular mechanisms of tumor treatment continues to deepen, the early drug evaluation system still needs a lot of work to improve the prediction of OS, the most critical therapeutic target .
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Soaring 300%!
Time of Update: 2021-08-12
Sales of rasagiline mesylate tablets in terminal pharmacies in Chinese cities (unit: ten thousand yuan) Source: Mi Nei. com, China's urban physical pharmacy terminal competition pattern There are currently three companies to submit a new registration classification rasagiline mesylate tablets listing application, the first newspaper Qilu Pharmaceutical products industry, the first to win the first copy .
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Roche's ADC drug Hersele's new indication is approved again to protect the long-term survival of patients with HER2-positive advanced breast cancer
Time of Update: 2021-08-11
On June 23, Roche Pharmaceuticals China announced that the State Administration of Medicines has officially approved the innovative targeted drug Hercelium® (English trade name: Kadcyla®, generic nam
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1.8 billion oral hypoglycemic drugs "fight"! Better Incoming
Time of Update: 2021-08-11
Medical Network, June 23 News On June 21, the official website of the State Food and Drug Administration showed that Chengdu Better Pharmaceutical's metformin hydrochloride sustained-release tablets were approved for production of generic 4 types, which are deemed to have been reviewed .
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Roche gantenerumab reduces biomarker levels in DIAD patients
Time of Update: 2021-08-11
In a Phase 2/3 study led by Washington University School of Medicine and reported last year, the experimental anti-amyloid antibodies of Eli Lilly and Roche failed to improve the symptoms of Alzheimer’s disease.
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uniQure announces the results of etranacogene dezaparvovec Phase 3 HOPE-B study
Time of Update: 2021-08-11
HOPE-B is a multi-country, open-label, single-arm clinical trial, with 54 cases classified as moderate or severe (defined as FIX activity ≤ 2% of normal) and hemophilia B requiring preventive FIX replacement therapy Adult patients were enrolled in a prospective observational lead-in period of 6 months, during which the patients continued to receive their current standard of care therapy to establish a baseline annual bleeding rate (ABR) .
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Jianghu Upright Antibody Optimization
Time of Update: 2021-08-11
The traditional method of antibody development is to immunize mice with antigens to obtain hybridoma cells that can continuously secrete antibodies, and use selected leads to generate chimeric or humanized antibodies after screening .
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AZ Bydureon treatment of type 2 diabetes in children and adolescents with Phase 3 clinical results positive
Time of Update: 2021-08-10
And 16 years after Exenatide was on the market, its long-acting sustained-release preparation Bydureon BCise became the first weekly GLP-1RA to complete a phase 3 clinical trial in children and adolescents with type 2 diabetes .
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Gilead Announces New Data from Two Studies of Hepcludex, the First Virus Entry Inhibitor
Time of Update: 2021-08-10
The results of the phase 2b study showed that when bulevirtide was used alone or in combination with peginterferon alpha-2a for 24 weeks, the level of HDV-RNA decreased significantly and the activity of biochemical diseases improved .
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2 billion injections!
Time of Update: 2021-08-09
Source: Listed company announcements, Mi Nei. com database Medical Network, July 5 News On July 1, Tianyao shares announced that its subsidiary Tianjin Jinyao Pharmaceutical's methylprednisolone sodium succinate (40mg specification) for injection was approved as a supplementary application .
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Announcement of Phase II Trial Results of Volagidemab, a new diabetes drug in Jiuzhitang's shareholding company
Time of Update: 2021-08-09
(referred to as “kexinmeide”), and its parent company, REMD Biotherapeutics Inc, had a joint venture with the American Diabetes Association (ADA) ) At the 81st Scientific Meeting (ADA2021), the Phase II clinical trial results of a new drug Volagidemab (the REMD-477 project) for the treatment of patients with type 1 diabetes were first released .
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Merck/Alpine collaborative immuno-oncology research evaluation ALPN-202 combined with Keytruda
Time of Update: 2021-08-09
Recently, clinical-stage immunotherapy company Alpine Immune Sciences has reached a cooperation agreement with Merck to evaluate the effectiveness and safety of Alpine’s checkpoint and Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) in the treatment of cancer .
