Search Results for “FDA” – Page 88 – media

Another new COPD drug is coming

On September 6, GlaxoSmithKline (GSK) announced that its Phase 3 MATINEE study of its IL-5 antibody Nucala (mepolizumab) in the treatment of COPD achieved positive results. Compared with the placebo group, the Nucala treatment group achieved a statistically significant reduction in the annualized rate of moderate to severe exacerbations, but specific data have not yet been released. Two months ago, two COPD drugs with new mechanisms: ensifentrine and dupilumab were approved for marketing in the United States and Europe, refreshing the treatment model of this severe respiratory disease. Mepolizumab is expected to join this new round of competition. COPD: The third leading cause of death in humans Chronic obstructive pulmonary disease (COPD), referred to as COPD, is a common, preventable and treatable heterogeneous disease. According to statistics from the World Health Organization, COPD has become the third leading cause of death in humans, with about 11% of people dying from ...
- Source: drugdu
- 59
- September 14, 2024
A Chinese innovative pharmaceutical company “died”

On September 5, Connect (Nasdaq: CNTB), a global clinical-stage biopharmaceutical company headquartered in the United States, announced its financial results for the six months ended June 30, 2024 and announced plans to large-scale attrition. In addition, as part of Connect’s transformation into a U.S.-focused company, the company plans to significantly reduce the scale of its operations in China. Just a few months ago, Connect was an innovative pharmaceutical company in China. All these changes are rooted in the clinical setbacks of Connect’s core pipeline product, Rademikibart (CBP-201). This is a fully human monoclonal antibody targeting IL-4Rα, which is a common subunit of IL-4Rα and IL-13 receptors. It directly targets Sanofi’s new autoimmune drug Duprilumab. anti. In the CBP-201 clinical data previously announced by Connect, although some connotations of long-term efficacy data were seen, the improvement in the 16-week data was weaker than that of dupilumab; in addition, because it was ...
- Source: drugdu
- 51
- September 13, 2024
【EXPERT Q&A】What certification is required for medical device export clearance to the United States?

Drugdu.com expert’s response: Exporting medical devices to the United States for customs clearance involves fulfilling a series of certifications and requirements, primarily encompassing the following aspects: Ⅰ. FDA Registration and Certification FDA Registration: Manufacturers or exporters need to register with the Food and Drug Administration (FDA) in the United States to legally sell medical devices in the American market. This process is typically completed through FDA’s Electronic Registration System (FURLS). 510(k) Premarket Notification: For medical devices classified as “Class II” (Premarket Notification), a 510(k) submission is generally required. This application demonstrates that the device is technologically similar to a legally marketed device and meets FDA requirements. The review period typically takes 90 days. PMA Application: For high-risk medical devices classified as “Class III” (Premarket Approval), a PMA (Premarket Approval Application) may be necessary. This is a more rigorous application requiring substantial clinical data and evidence to prove the safety and ...
- Source: drugdu
- 65
- September 13, 2024
The highest increase was 103398%! The revenue of these pharmaceutical companies soared

In September, the 2024 semi-annual reports of various companies have basically been disclosed. According to statistics from Cyber Blue, among the 493 A-share listed pharmaceutical companies (according to the industry classification of Tonghuashun, the same below), the number of companies with year-on-year decline and growth is close to “50-50” – 242 pharmaceutical companies have a year-on-year decline in revenue, accounting for 49% of the total; 252 have an increase in revenue, accounting for 51% of the total. Among the 242 pharmaceutical companies whose revenue decreased compared with the same period last year, 40% of them fell by less than 10%; there were 12 companies with a decline of more than 50%, of which the company with the largest decline had a year-on-year revenue decline of more than 97%. Among the 252 pharmaceutical companies with year-on-year revenue growth, 183 had an increase of less than 20%, accounting for ...
- Source: https://mp.weixin.qq.com/
- 52
- September 12, 2024
Optical equipment giant, entering the ‘ophthalmic metaverse’

Recently, optical giant Zeiss announced that it has reached a cooperation agreement with Swiss AR/VR company Creal to jointly develop a new digital vision healthcare platform based on light field display technology, planning to completely revolutionize existing vision diagnosis and treatment procedures. Light field display is a method that utilizes ray tracing to reconstruct 3D scenes in space, and is currently the most likely practical 3D display technology. Compared with holographic display technology, which is also a true 3D display technology, light field display has smaller data volume, lower cost, and smaller volume. Zeiss will introduce CREAL’s light field display technology to create a device that can digitally reproduce real refractive testing. The new device will be able to virtually simulate traditional glasses and contact lenses, eliminating the need to switch lenses repeatedly. Objects in front of us will be displayed at different focal lengths, and through precise digital imaging, ...
- Source: drugdu
- 46
- September 12, 2024
Vaxcyte’s stock price soared after achieving a ‘stunning’ victory in the competition against Pfizer’s 31 valent pneumococcal conjugate vaccine (PCV)

Editor’s Bio Products Circle Vaxcyte has released Phase 1/2 data for its 31 valent pneumococcal vaccine candidate, which analysts have described as “astonishing”. If these data can be replicated in large-scale critical studies, it could pose a serious threat to Pfizer’s Prevnar 20. Vaxcyte’s half period data for VAX-31 in adults aged 50 and above against Prevnar 20 is “extraordinary” and suggests a “killer product in the pneumococcal conjugate vaccine category,” said analysts at Leerink Partners in a report on Tuesday. Leerink analyst said, “We believe that these data support VAX-31’s potential to gain a significant market share in the pneumococcal conjugate vaccine market expected to exceed $10 billion by 2030+ Due to this positive reading, Mizuho analysts referred to it as the “best case scenario,” and Vaxcyte’s stock price jumped about 44% at the release time on Tuesday morning.Today, we are opening a new chapter for Vaxcyte as we ...
- Source: drugdu
- 68
- September 9, 2024
Chinese neurological device giant rushes for IPO

Recently, Beijing Pinchi Medical Equipment Co., Ltd. (hereinafter referred to as “Pinchi Medical”) completed the listing guidance registration and planned IPO at the Beijing Securities Regulatory Bureau, and the guidance institution is CICC. According to the counseling work arrangement, CICC plans to complete the counseling plan for Pinchi Medical in November and December this year, and apply to the Beijing Securities Regulatory Bureau for counseling acceptance. After the counseling is completed and accepted, Pinchi Medical may apply for an IPO. This is another brain pacemaker company that plans to go public through an IPO in 2023 after Jingyu Medical started filing for listing counseling. According to Smart Medical Equipment, so far, the only two local companies that mass-produce brain pacemakers have embarked on the road to IPO. Founded in 2008, Pinchi Medical is a high-tech enterprise specializing in the research and development, production and sales of a series of neuromodulatory ...
- Source: drugdu
- 61
- September 9, 2024
Domestic neural device giant sprints for IPO

Recently, Beijing Pinchi Medical Equipment Co., Ltd. (hereinafter referred to as “Pinchi Medical”) completed its IPO counseling and registration with the Beijing Securities Regulatory Bureau, with the counseling agency being China International Capital Corporation (CICC). According to the coaching work arrangement, CICC plans to complete the coaching plan for Pinchi Medical in November December this year and apply for coaching acceptance from the Beijing Securities Regulatory Bureau. After completing the coaching acceptance, Pinchi Medical may apply for IPO. This is another brain pacemaker company planning to go public in 2023, following Jingyu Medical’s IPO guidance filing. According to reports from Smart Medical Devices, the only two local companies that mass produce brain pacemakers have now embarked on the path of IPO and planned to go public. Tsinghua endorsement, Pinchi Medical is aiming for IPO Pinchi Medical was founded in 2008 and is a high-tech enterprise specializing in the research, development, ...
- Source: drugdu
- 68
- September 7, 2024
【EXPERT Q&A】Where to check pharmacovigilance data?

Drugdu.com expert’s response: Regarding the inquiry of pharmacovigilance data, you can access the following specific agencies: Ⅰ. National Medical Products Administration (NMPA) and Its Subsidiaries NMPA Official Website: Each year, the NMPA releases the “Annual Report on National Adverse Drug Reaction Monitoring,” which informs the public of the annual status of adverse drug reaction monitoring in China. These reports and related pharmacovigilance information can be found on the NMPA’s official website (nmpa.gov.cn). National Center for Adverse Drug Reaction Monitoring (NCADR): The NCADR regularly compiles and publishes domestic pharmacovigilance information, as well as international pharmacovigilance alerts. This information can also be accessed on the NMPA’s official website or the NCADR’s official website (cdr-adr.org.cn). Ⅱ. Local Governments and Agencies Some local governments or drug regulatory agencies may have established their own pharmacovigilance databases or information platforms. For instance, Shandong Province has the “Medication ‘Alert’ Platform,” which utilizes information technology to provide channels ...
- Source: drugdu
- 77
- September 5, 2024
semaglutide is gaining ground

As we enter 2024, the global competition for “King of Medicine” is becoming increasingly fierce. In the first half of the year, Merck’s PD-1 monoclonal antibody pembrolizumab (trade name: Keytruda, “Keytruda”) successfully won the title of the world’s “king of medicine” with $14 billion. Novo Nordisk’s semaglutide (including 3 brands: Ozempic/Rybelsus/Wegovy) ranked second with sales of about $13 billion in the first half of this year, further narrowing the gap with Keytruda, and the year-on-year growth rate exceeded 40%, leaving suspense for the “king of medicine” competition in the second half of the year. On the other hand, in terms of sales growth, Eli Lilly’s tirpotide (including two brands: Mounjaro/Zepbound) grew 330% year-on-year in the first half of this year to $6.658 billion, making it the fastest-growing drug in history. Since its first indication was approved in 2022, it has grown into a super blockbuster with annual sales of over ...
- Source: drugdu
- 58
- September 5, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.