PharmaFocus Today – Page 15 – 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
Important document! Secondary bargaining is “stopped”

Regarding the scope of the special rectification of “secondary bargaining” defined in the notice, the author consulted the relevant responsible personnel of the Finance Department of the Hunan Provincial Health Commission, and received the reply: This “secondary bargaining” rectification focuses on the behavior of public hospitals not settling according to the agreed purchase and sale prices in order to obtain irregular rebates. At present, most hospitals in Hunan Province are involved in “secondary bargaining” rebates to varying degrees and in different forms, such as bearing the cost of drug consumption fund recovery and deducting penalties for excessive drug use as the name and method of rebates. The rebate income from “secondary bargaining” is used by hospitals to supplement related operating costs. This time, the Hunan Provincial Health and Health System carried out a special rectification work on “secondary bargaining” of drug consumption, requiring it to be completed in October. In ...
- Source: drugdu
- 74
- October 16, 2024
Yunnan Baiyao executive team adjustment

On October 11, Yunnan Baiyao issued the “Announcement on the Appointment of Senior Management Personnel”, appointing Li Shengli as its senior vice president. Li Shengli has held important positions in many pharmaceutical companies, including general manager, president, CEO, and chairman of Jiangsu Wanbang Pharmaceutical Marketing Biochemical Oncology Division, co-president, president, and chairman of Jiangsu Fosun Pharmaceutical Sales Co., Ltd., assistant to the president, vice president, senior vice president, executive president, and chief development officer of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. The joining of Li Shengli once again verified the change in Yunnan Baiyao’s talent training model, from internal talent training to the “internal training + external introduction” dual-channel talent model, to create a high-quality talent team that meets its future development needs. Pharmaceutical companies have established their own talent training and selection system, and the company and employees understand each other, have high loyalty, and there is almost no ...
- Source: drugdu
- 59
- 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
GCGR agonist rejected twice

Original Time Biopharmaceutical Editor October 14, 2024 09:20 Shanghai The weight loss drug concept stock Zealand has suffered another setback, as its new drug Dasiglucagon, which was launched to treat congenital hyperinsulinemia (CHI) in children, has once again been rejected by the FDA. Last December, Dasiglucagon was rejected by the FDA for the first time due to the discovery of defects in a third-party contract manufacturing factory. Zealand pointed out that the main reason for Dasiglucagon’s second rejection was that the FDA failed to complete the re inspection of third-party production factories, resulting in the approval process being put on hold. The FDA did not raise any concerns about the effectiveness or safety of Dasiglucagon. Dasiglucagon is a glucagon receptor (GCGR) agonist that acts to release stored glycogen from the liver into the bloodstream. Hypoglycemia is one of the most common acute complications of diabetes, and patients who have the ...
- Source: drugdu
- 56
- 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
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- 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
- 72
- 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

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