Search Results for “EC” – Page 184 – media

The “wolf” is really here, and the elimination of zombie approvals has begun

While the industry is still waiting to see whether the “zombie” approvals will really be eliminated, the new regulations of the National Medical Products Administration have provided a policy basis for the elimination of “zombie” approvals-On October 12, 2024, the National Medical Products Administration issued a notice on the application procedures and application materials requirements for re-registration of domestically produced drugs (No. 38 of 2024), which will be implemented from January 1, 2025. According to the new regulations on re-registration, three types of approvals will face the risk of delisting. The first type of risky products: “zombie” approvals, especially those with missing production scope and production address The “zombie” approvals mentioned above are very likely to be delisted: The “Application Procedures for Re-registration of Domestically Produced Drugs” clearly requires “strengthening the management of drugs that have not been produced on a commercial scale during the period from the approval of ...
- Source: drugdu
- 57
- October 16, 2024
“Sniper War” of Star Targets of Lung Cancer

Recently, Ascentage Pharmaceuticals’ APG-2449 has obtained CDE approval and will conduct two registered Phase III clinical studies for the treatment of non-small cell lung cancer. APG-2449 is a small molecule FAK inhibitor independently developed by Ascentage Pharmaceuticals with oral activity. It is a third-generation ALK/ROS1 TKI and the first FAK inhibitor in China to be approved by CDE for clinical trials. This may mean that the node for domestic drugs to disrupt the ALK target pattern is getting closer and closer, and it also indicates that the next blockbuster product of China’s innovative drugs is on the way. The saying “He who gets lung cancer gets the world” is widely circulated in the field of tumors. Lung cancer is the leading cause of morbidity and mortality of malignant tumors in China. The large number of lung cancer patients has always been a must-fight place for pharmaceutical companies. This is also ...
- Source: drugdu
- 45
- October 16, 2024
Africa Health

Organiser：Informa Markets Time：October 22 – 24, 2024 Address：19 Richards Drive Johannesburg Gauteng Midrand 1685 South Africa Exhibition hall：Gallagher Convention Centre Product range: Medical Devices: Laboratory equipment and configurations, emergency and transportation facilities, surgical equipment, nursing and monitoring equipment, etc. Medical Technologies: Orthopedic and rehabilitation technologies, medical building facilities and technologies, medical information and communication technologies, etc. Pharmaceuticals: Various types of finished pharmaceuticals, medicinal products, medical excipients, etc. Hospital Supplies: Disposable medical supplies, medical disinfectants, etc. Medical Supplies: Medical clothing and laundry technologies, nutritional meal preparation equipment, medical furniture, etc. About Africa Health： The Africa Health Exhibition in Johannesburg, South Africa, is the most significant healthcare event on the African continent. For many years, our mission and vision at Africa Health, aligned with the African Health Organization, have been to bridge the gap in healthcare business, knowledge, and skill development through meaningful connections, bringing the future of healthcare to ...
- Source: drugdu
- 74
- October 15, 2024
Victory! FDA approves Pfizer’s hemophilia A or B monoclonal antibody drug Marstacimab

Pfizer – after starting a showdown with a radical investor, being betrayed by two former executives, reuniting with two former executives, and ending work on an RSV drug – finally has some good news, straightforward. On Friday, the FDA approved Pfizer’s hemophilia A or B drug Marstacimab, which will be sold under the Hympavzi brand. This therapy is an anti tissue factor pathway inhibitor that helps hemophilia patients form blood clots to limit their bleeding episodes. A Pfizer spokesperson stated in an email to Endpoint News that the wholesale procurement cost for this weekly drug is $795600 per year, which is consistent with the WAC pricing for available prophylactic treatments for hemophilia A or B. It plans to start selling this drug this quarter. This drug is packaged as a pre filled automatic injection pen, which analysts say can help it find a place in the market. Given the maturity ...
- Source: drugdu
- 61
- October 15, 2024
FDA Approves Pfizer’s Hemophilia A or B Monoclonal Antibody Drug Marstacimab

On Friday, the FDA approved Pfizer’s hemophilia A or B drug Marstacimab, which will be sold under the Hympavzi brand. This therapy is an anti tissue factor pathway inhibitor that helps hemophilia patients form blood clots to limit their bleeding episodes. A Pfizer spokesperson stated in an email to Endpoint News that the wholesale procurement cost for this weekly drug is $795600 per year, which is consistent with the WAC pricing for available prophylactic treatments for hemophilia A or B. It plans to start selling this drug this quarter. This drug is packaged as a pre filled automatic injection pen, which analysts say can help it find a place in the market. Given the maturity of factor replacement and the moderate improvement of Mastacrolizumab compared to conventional prevention, Pfizer will have to rely to some extent on the argument of convenience to gain traction, “TD Cowen analyst wrote in a ...
- Source: drugdu
- 59
- October 15, 2024
Sanxi Group’s Synthetic Biology Production Line is Delivered as Scheduled

It is reported that the total investment of the production line is about 60 million yuan, and it is equipped with four fully automatic precision fermentation production lines. These production lines are all equipped with advanced automated separation and purification systems, which can monitor various key parameters in the production process in real time, ensuring comprehensive, efficient, and precise control of product quality. The successful delivery of this project not only demonstrates Sanxi Group’s profound technical accumulation in the field of synthetic biological equipment manufacturing, but also demonstrates its efficient project management and delivery capabilities. In recent years, with the continuous development of technologies such as gene editing and artificial intelligence, synthetic biology has sparked a new wave of research. Scientists have high hopes for this cutting-edge science, hoping to use this technology to improve human health, address food crises, alleviate global warming and other common problems faced by humanity. ...
- Source: drugdu
- 57
- October 15, 2024
After the 2024 Nobel Prize is announced, what is the commercial value?

The 2024 Nobel Prize in Physiology or Medicine has finally been announced, and surprisingly, the previously highly requested GLP-1 target and alphafold system have not been awarded, and the award-winning fields are similar to last year, which are pioneers in the field of RNA. Last year it was mRNA, this year it is microRNA. On October 7 at 5:30 p.m., the Sweden Carolinska Institutet announced that the 2024 Nobel Prize in Physiology or Medicine was awarded to Victor Ambros and Gary Ruvkun · · for their “discovery of microRNAs and their role in post-transcriptional gene regulation.” It is reported that the two are professors at the University of Massachusetts Medical School and Harvard Medical School, respectively. As we all know, the winner of the Nobel Prize needs to go through a long time from making relevant achievements to winning the Nobel Prize: the Nobel Prize needs time to test its ...
- Source: drugdu
- 71
- October 15, 2024
InnoCare’s “novel TYK2 inhibitor” ushered in progress

Recently, InnoCare announced that the Phase II clinical study of ICP-488, a novel self-developed tyrosine kinase 2 (TYK2) inhibitor, in the treatment of moderate to severe plaque psoriasis, met the primary endpoint. In patients treated for 12 weeks, ICP-488 demonstrated superior efficacy and safety. ICP-488 met multiple efficacy endpoints in the once-in-a-day 6 mg and once-daily 9 mg dose groups, including Psoriasis Area and Severity Index (PASI) 75, PASI 90, PASI 100 (PASI score improvement from baseline ≥75%, ≥90%, and ≥100%), and static Clinician’s Global Assessment (sPGA) 0/1 (i.e., complete or basic clearance of lesions). The response rate of PASI 75 was 77.3% and 78.6%, respectively, in the once-daily 6 mg and 9 mg dose groups, compared with 11.6% in the placebo group (p<0.0001). The response rate of PASI 90 in the two dose groups reached 36.4% and 50.0%, respectively, compared with 0% in the placebo group (p<0.0001); The response ...
- Source: drugdu
- 68
- October 15, 2024
HUTCHMED’s Elunate ® (fruquintinib) was fully funded for inclusion in the Hong Kong Hospital Authority’s Drug Formulary

Chi-Med (China) Limited (“HUTCHMED”) today announced that Elunate ® (fruquintinib) has been added to the Drug Formulary of the Hong Kong Hospital Authority (“HA”) in the category of “Specialty Drugs”. Patients who are prescribed the new drug for specific clinical applications in public hospitals or clinics are only required to pay the standard fee. Elunate ® received approval from the Pharmacy and Poisons Board of Hong Kong in January 2024 for the treatment of adult patients with metastatic colorectal cancer who have been treated. The first innovative anti-oncology drug to be directly included in the HA’s Drug Formulary category, and the first new drug to be approved under the “1” mechanism of the HA’s Drug Formulary, which was quickly included in the Drug Matrix and the “1” mechanism, helping patients accelerate access to important treatment options. Elunate ® is the first oral targeted therapy approved in Hong Kong for the ...
- Source: drugdu
- 60
- October 15, 2024
460 million! Migraine innovative medical device company completes Series B financing

Recently, ShiraTronics, an innovative medical device company for migraine, announced the completion of a $66 million (approximately RMB 460 million) Series B financing to support its innovative migraine treatment system. This round of financing was led by new investor Norwest Venture Partners, and other new investors included Seroba, OSF Ventures, Global BioAccess Fund, and an undisclosed strategic investor. In addition, some existing investors such as U.S. Venture Partners, Amzak Health, Treo Ventures, and Aperture Venture Partners also participated in this round of financing. ShiraTronics, located in Minneapolis, Minnesota, is a clinical-stage medical device company focused on developing neurostimulation therapies for chronic migraine patients. It is committed to improving the lives of chronic migraine patients and received the FDA breakthrough device designation in 2021. The name of the disease migraine is not unfamiliar, and it is often heard in life, so the migraine market is also quite extensive worldwide. According to ...
- Source: drugdu
- 49
- October 15, 2024

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