Search Results for “Clinical Trial” – Page 43 – media

There is no Summit in China

Innovative drugs are a gamble, a big gamble. Once the research and development fails, the stock price collapses and financing is unavailable. On the contrary, if the gamble is won, it is not impossible for the stock price to soar. Especially in the US stock market, it has always been so violent. For the losers, there are only two options: disband on the spot or fight back. The so-called fight back means finding a way to start the next round of innovation gambling. This requires both money and the courage to gamble. Summit is an old “gambler” who plans to gamble again. After its establishment in 2003, Summit focused on the anti-infection field, and its core product was benchmarked against vancomycin, the “last line of defense for antibiotics.” It landed on Nasdaq in 2015, but because the core product ridinilazole did not perform well in the final clinical data, the ...
- Source: drugdu
- 71
- September 21, 2024
ESMO 2024｜Major changes in liver cancer treatment

To this day, liver cancer is still the top killer on my country’s cancer “killer list”. According to the latest data on cancer in China in 2022 released by the National Cancer Center (NCC) in February 2024, liver cancer ranked second with 316,500 deaths. The core reason is that despite the continuous progress in first-line treatment, the existence of drug resistance has made the current second-line treatment of liver cancer face great challenges. First of all, for patients whose disease progresses after TKIs treatment, the clinical needs are far from being met. Whether it is changing TKIs or using immunotherapy, the degree of clinical benefit needs to be improved. Specifically, the key trials of multikinase inhibitors regorafenib and cabozantinib in patients whose disease progressed after sorafenib treatment showed that the objective response rate (ORR) was only 11% and 4%, respectively, and the proportion of patients who achieved remission was extremely ...
- Source: drugdu
- 78
- September 21, 2024
Five innovative medical devices enter special review process

Recently, the Equipment Review Center of the National Medical Products Administration released the results of the special review application for innovative medical devices (No. 8 of 2024), intending to approve 5 innovative medical device projects to enter the special review process. 1. Human homologous recombination repair defect detection kit (high-throughput sequencing method): Xiamen Aide Biomedical Technology Co., Ltd Xiamen Aide Biopharmaceutical Technology Co., Ltd. (hereinafter referred to as Aide Biotechnology) was established in 2008. It has long been deeply involved in the field of tumor gene testing, focusing on tumor drug co diagnosis. Relying on powerful bioinformatics algorithms, it has laid out detection reagents, software, and supporting instruments for various technology platforms, and provides detection services and drug clinical research services. In terms of products, Eide Biological Products has a wide range of products, which can detect the mutations of EGFR, KRAS, BRAF and other common genes, covering the disease ...
- Source: drugdu
- 63
- September 20, 2024
Novo Nordisk’s new anchor

In the first half of 2024, Novo Nordisk achieved revenue of 133.4 billion Danish kroner, a year-on-year increase of 24%, and its performance continued to grow. The increase in the volume of semaglutide is a key factor in the growth of performance. Ozempic, a semaglutide hypoglycemic injection, achieved revenue of 56.7 billion Danish kroner, Rybelsus, a semaglutide hypoglycemic oral agent, achieved revenue of 10.9 billion Danish kroner, and Wegovy, a semaglutide weight loss injection, achieved revenue of 21 billion Danish kroner. The total sales of semaglutide were 88.7 billion Danish kroner, a year-on-year increase of 43%, accounting for 2/3 of Novo Nordisk’s total revenue. While semaglutide is selling well around the world, Novo Nordisk is also constantly adjusting and optimizing its R&D strategy and business layout. By enriching its product portfolio, it will further strengthen its dominant position in the field of blood sugar and fat reduction. At the same ...
- Source: drugdu
- 53
- September 20, 2024
How many drugs does Biotech need to sell to avoid losing money?

Looking around the world, biotech is a group with extremely high “metabolism”. According to statistics from GF Securities, since 1990, more than 600 biotech companies have IPOed on Nasdaq. However, as of June 30, 2020, only 12 biotechs have relatively stable income and positive cash flow. Extending the timeline, from the rise of the concept of biotech in the 1980s to the present, in 40 years, there are only a few who have entered the pharma camp by buying on their own. Why is it difficult for biotech to survive for a long time? This is determined by the business model. Compared with large pharmaceutical companies with average growth but strong certainty, biotech is a divergent innovation model, and the growth process is full of uncertainty. In other words, due to the high risk of R&D and the uncertainty of sales, most biotechs can’t run the business model at all, ...
- Source: drugdu
- 52
- September 20, 2024
Andon Health has a tendency to invest in unmanned aerial vehicle medical transportation

According to the Qichacha APP, Tianjin Jiuyin Electronic Technology Co., Ltd. was recently established, with Li Kang as the legal representative and a registered capital of 500000 yuan. Its business scope includes: sales of satellite mobile communication terminals; Sales of navigation terminals; Sales of wearable smart devices; Sales of intelligent unmanned aerial vehicles, etc. Qichacha’s equity penetration shows that the company is wholly owned by Andon Health. In the field of medical applications, the “low altitude+medical rescue” unmanned aerial vehicle comprehensive solution has achieved normalized low altitude medical transportation services in multiple provinces and cities across the country. With the help of unmanned aerial vehicle technology, it innovates three key medical logistics scenarios: blood transportation, medical material distribution, and rapid response to emergency supplies. Will Jiu’an be involved in this direction in the future? Worth paying attention to. Has launched multiple wearable products, with asset management becoming one of its ...
- Source: drugdu
- 61
- September 19, 2024
1.5 billion US dollars! Capricor Therapeutics partners with Nippon Pharmaceutical Co., Ltd

Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. On September 17, 2024, Capricor Therapeutics, a biotechnology company developing transformed cell and exosome therapies for the treatment of rare diseases, announced that it had signed a binding term sheet with Nippon Pharma. The terms state that Nippon Pharma will commercialize and distribute Capricor’s main asset, deramiocel, in Europe for the treatment of Duchenne muscular dystrophy (DMD). Capricor will receive a $15 million equity investment at a 20% premium and a $20 million advance payment upon signing the final agreement. The potential milestone amount is as high as $715 million, with product revenue accounting for double digits. The total ...
- Source: drugdu
- 56
- September 19, 2024
Chinese non-opioid long-acting analgesics “break through one after another”

Recently, Kelun Pharmaceutical announced that its subsidiary Hunan Kelun Pharmaceutical’s chemical drug “Bupivacaine Liposome Injection” was approved for marketing by the National Medical Products Administration (trade name Bruco®), which was approved according to Class 3 chemical drugs and deemed to have passed the generic drug quality and efficacy consistency evaluation. Kelun Pharmaceutical’s Bruco® is the second bupivacaine liposome injection product to be launched in China. Hengrui Medicine’s bupivacaine liposome injection generic drug (trade name: Aihengping) was approved in November 2022. It is the world’s first generic drug and also the first long-acting postoperative analgesic drug to be launched in China. In July this year, Aihengping was approved for marketing by the FDA, becoming the world’s first manufacturer to obtain generic drug approval for this variety in the United States. Behind the successful breakthroughs of domestic pharmaceutical companies is the growing market demand in the field of long-acting postoperative analgesic preparations ...
- Source: drugdu
- 58
- September 19, 2024
The light of domestic production! Kangnuo’s IL-4R α antibody drug has been approved for market by NMPA

On September 12th, Konya announced that the company’s independently developed Class 1 new drug, Kangyueda ® (Sipuximab Injection) has been officially approved for marketing by the National Medical Products Administration for the treatment of moderate to severe atopic dermatitis in adults. As the first domestic and second globally approved IL-4R alpha antibody drug, Kangyueda ® The launch of Sipuqibai monoclonal antibody not only fills the gap in the field of domestic atopic dermatitis biologics, but also brings new hope for patients with moderate to severe atopic dermatitis to achieve higher treatment goals. Kangyueda ® (Sprucubizumab) Kangyueda ® The Phase III clinical trial of (Sipuximab) is the largest randomized controlled trial of dermatological subjects completed in China to date. The research results show that, The first dose takes effect quickly: Kangyueda ® The first dose of single agent treatment with (Sipuximab) can quickly relieve itching symptoms within one day; After 2 ...
- Source: drugdu
- 68
- September 14, 2024
Obeticolic acid ‘fate judgment’

Since its launch in 2016, Ocaliva (obeticolic acid) has not only failed to successfully develop a new indication for MASH, but also struggled to survive in primary biliary cirrhosis (PBC), and is now facing regulatory scrutiny once again. Recently, the FDA released a pre conference briefing document questioning the effectiveness and safety of Ocaliva for PBC in its approved indications. In this briefing document, the FDA criticized two clinical studies, 747-302 and 747-405. The FDA pointed out that the 747-302 trial failed to demonstrate statistically significant benefits of Ocaliva for PBC, but instead increased the risk of liver transplantation or death in patients. For 747-405, the clinical trial did not meet sufficient and well controlled regulatory standards. Today, members of the FDA Expert Advisory Committee will vote on whether to convert it from accelerated approval to full approval. Out of NASH Ocaliva is a potent and specific agonist of ...
- Source: drugdu
- 73
- September 14, 2024

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