Search Results for “FDA” – Page 79 – media

FDA approval granted to Emmaus for sickle cell therapy

Emmaus Medical recently received FDA (The U.S. Food and Drug Administration) approval for sickle cell disease therapy Endari (L-gluitamine), ending two decades of drought for treatment of the disease and giving an alternative to the only other drug on the market, hydroxyurea.
- Source: fiercebiotech
- 531
- June 9, 2017
Company Insight FDA therapy
Total investment is 500 million yuan! The first integrated intelligent factory project for synthetic biology CDMO full process in Jiangsu Province has been launched

On the morning of October 22nd, Fenghuang Town successfully signed a contract with Suzhou Womei Biotechnology Co., Ltd. for the “Womei Biosynthetic CDMO Factory” project, which is the first project to settle in Feixiang Pharmaceutical Industrial Park since its approval. Teng Xiaonuo, General Manager of Suzhou Womei Biotechnology Co., Ltd., Professor Ren Guobin, Vice Dean of the Research Institute of East China University of Science and Technology, Wang Weimin, Secretary of the Phoenix Town Party Committee, Tian Wenhua, Deputy Secretary of the Town Party Committee and Mayor, Ji Xiaoyang, Deputy Secretary of the Town Party Committee, and others participated in the signing. This project is based on leading process control and intelligent manufacturing technologies at home and abroad, and aims to establish a green intelligent factory that integrates consumables, process engineering, and equipment. It balances production efficiency and cost control, and strives to build a first-class synthetic biology CDMO industry ...
- Source: drugdu
- 29
- November 1, 2024
Determination to break up

The operations of Cinda, a star company in China’s biotech industry, in the past two days have finally made an investor who has firmly held Cinda shares for many years determined to break up: no longer obsessed with Cinda’s future, and resolutely clear all Cinda shares. The spin-off of Cinda’s subsidiaries and the founder’s “low-price” purchase of the subsidiary’s equity are still fermenting. The news was announced on Friday night. In the bull market where all industries have been rising for several weeks, Cinda fell 12.54% on Monday, and fell again on Tuesday after a conference call to explain the matter, closing down 4.01% on the day. On Wednesday, Cinda’s stock continued to fall, falling 4.85% in midday trading today. “It’s mainly because it’s a bull market now. If it were three months ago, it would have basically fallen by 30%.” An industry insider said. The market’s disappointment with Innovent ...
- Source: drugdu
- 31
- November 1, 2024
brain-computer interface only costs $5,000

In reality, the brain-computer interface is connected to your brain at one end, extracting your ideas from the dense and complex neuronal electrical signals, and connected to external devices such as computers or machinery at the other end, directly bypassing your body to turn ideas into control signals and further execute commands. It does not need to rely on the peripheral nerves and muscle systems of your limbs to directly establish direct information exchange between the brain center and external devices. Musk released a monkey for experiment in 2021. The monkey typed a line of words “I want to eat snacks” on the computer through mind operation. This is supported by brain-computer interface technology. The cochlear implant that helps the disabled to obtain sound is the most successful and most popular technology for brain-computer interface so far. Its principle is to convert sound signals into electrical signals and transmit them ...
- Source: drugdu
- 26
- November 1, 2024
“Plan B” for Chinese pharmaceutical companies to go overseas

Weighing the risks is the primary issue that all pharmaceutical companies need to consider when going overseas. The cost of going overseas is not cheap. Not to mention the time cost required to build overseas clinical, promotion, and registration experience, the capital cost is the top priority. BeiGene provides a good reference: although it has seen the dawn of profitability, this is based on the total loss of nearly 50 billion yuan in the past five years; Legend Biotech’s overseas cost is not low either. It is estimated that it has spent at least 1 billion US dollars since the establishment of the Xidaqiolunsai project. Industry insiders commented that this is far more expensive than imagined. From the perspective of capital investment alone, it can be asserted that there are not many pharmaceutical companies that can play the two cards of “local + going overseas” at the same time. To ...
- Source: drugdu
- 41
- October 30, 2024
Apple’s “killer move” will change the world of diabetes?

Recently, Bloomberg reported that Apple selected some employees to conduct a blood sugar APP test. During the test, the subjects actively monitored their blood sugar through various devices on the market, and then recorded the changes in blood sugar levels caused by food intake. This study may allow Apple to more deeply integrate third-party blood sugar tracking into its own products. Apple has been planning blood sugar monitoring for a long time. In 2010, Jobs led the acquisition of RareLight, a non-invasive blood sugar monitoring company. In 2015, Apple’s frontier exploration department XDG took over the non-invasive blood sugar detection project and has invested a lot of money in recent years for concept verification. In February last year, Apple’s non-invasive blood sugar monitoring project was reported to have a major breakthrough. According to reports, Apple is developing a silicon photonic chip and a measurement process called “optical absorption spectroscopy”, which ...
- Source: drugdu
- 39
- October 30, 2024
BeiGene PD-1 issues first prescription in the United States, opens new chapter with its own international solid tumor commercialization team

In late October, BeiGene’s self-developed PD-1 inhibitor, Trastuzumab (English trade name: TEVIMBRA), was launched ®， Chinese product name: Baize An ®） The first prescription was issued in the United States, officially entering the American market and bringing new treatment options to local patients. This milestone also marks the beginning of a new chapter for BeiGene’s own commercialization team for solid tumors in the United States.Teralizumab was approved by the US Food and Drug Administration (FDA) in March 2024 for the treatment of adult patients with unresectable or metastatic esophageal squamous cell carcinoma (ESCC) who have previously received systemic chemotherapy (excluding PD-1/L1 inhibitors). In October 2024, BeiGene announced the commercial launch of Trastuzumab in the United States, benefiting this patient population at a price 10% lower than other PD-1 therapies approved for this indication. The first prescription of Trastuzumab in the United States has become another important milestone in the company’s ...
- Source: drugdu
- 41
- October 29, 2024
Hengrui Medicine Reports Revenue and Net Profit Growth in Q3

On the evening of October 24, Hengrui Medicine announced its Q3 performance report for 2024, showcasing steady growth in performance. For the first three quarters of 2024, Hengrui reported an operating revenue of 20.189 billion yuan, marking an increase of 18.67% year-on-year. The net profit attributable to shareholders reached 4.620 billion yuan, an increase of 32.98%, while the net profit after deducting non-recurring gains and losses was 4.616 billion yuan, reflecting a 37.38% increase, demonstrating robust development momentum. According to the report, Hengrui’s R&D expenditures reached 4.549 billion yuan in the first three quarters of 2024, marking a significant increase of 22% year-on-year. This ongoing high-intensity investment in R&D is providing strong momentum for the transformation of the company’s innovative achievements. As a result of these sustained investments, Hengrui is seeing a continual emergence of innovative outcomes. During the reporting period, Hengrui launched its self-developed Class 1 new drug, Fuhuanqi ...
- Source: drugdu
- 55
- October 28, 2024
GLP-1 counterfeit drugs rampant, Lilly will file another lawsuit

Eli Lilly has taken further legal action against the continuous emergence of counterfeit products of Tilpotide. Recently, Eli Lilly has filed a lawsuit against three suppliers of counterfeit tiltrotide products that have not been approved by the FDA. The company is seeking a court order to stop the sale of these counterfeit tiltrotide products and demand economic compensation from these suppliers. The rampant use of counterfeit drugs The soaring demand for GLP-1 has not only made Novo Nordisk and Eli Lilly one of the most valuable companies in Europe, but also led to long-term supply shortages around the world. In order to get a share of the pie, some illegal merchants have engaged in rampant counterfeiting and forgery of the products of the two companies. These unregulated counterfeit drugs pose significant risks to the health of patients and may even endanger their lives. In December last year, the FDA issued ...
- Source: drugdu
- 44
- October 26, 2024
Eight commonly used immune cell therapies open up a new era of healthcare

Introduction: The era of chemotherapy cannot solve the “pain points” of relapsed and refractory diffuse large B-cell lymphoma, but the era of new cell drugs has solved them. And this new cellular drug, CAR-T cell therapy, which has become a hot topic in recent years, has opened up a new era of medical treatment, with a market size of trillions of dollars. Immune cell therapy aims to enhance the immune system’s ability to fight cancer. Manufacturing cell therapy requires collecting a specific set of cells from the blood, modifying them to produce more powerful attacks on the patient’s cancer cells, and then re injecting them into the patient’s body. At present, many types of cancer cell therapies are being explored, including CAR-T cells, other genetically modified T cells, tumor infiltrating lymphocytes (TIL), NK cells, CIK cells, B cells, etc. Extracting immune cells from patients’ bodies and modifying them to make ...
- Source: drugdu
- 47
- October 26, 2024

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