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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
- 69
- 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
- 109
- 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
- 71
- 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
- 70
- 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
- 115
- 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
- 80
- 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
- 105
- 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
- 61
- October 15, 2024
$2.2 billion settlement, GSK pays for safety

Zantac was originally a popular heartburn drug. From being popular all over the world to being withdrawn from the market due to carcinogenic risks, the years-long litigation disputes can be regarded as a slow and bumpy roller coaster for patients and manufacturers. This storm can be traced back to June 2019. At that time, Valisure discovered and informed the FDA during routine batch testing that the active ingredient ranitidine in Zantac would degrade under certain conditions and produce N-nitrosodimethylamine (NDMA), a Class 2A carcinogen. In September of the same year, Valisure formally submitted a citizen petition to the FDA, requesting the recall of all products containing ranitidine. Since then, Zantac has been deeply involved in the carcinogenic storm. The FDA further found that the higher the storage temperature or the longer the storage time of Zantac, the higher the risk of exceeding the standard of NDMA, which was originally very ...
- Source: drugdu
- 106
- October 14, 2024
A tumultuous time for the king of orphan drugs

More than 20 years ago, research on rare diseases and the treatment of rare diseases were very rare in the medical community. The small market size of rare diseases and the huge difficulty in research and development have made pharmaceutical companies shy away from this field. In the past 25 years, BioMarin has launched eight rare disease drugs with strong R&D capabilities. Arguably, this record is unmatched by few companies in the biotech industry. However, with the failure of the commercialization of its highly-anticipated hemophilia A gene therapy, Roctavian, a strategic review began. Since the beginning of this year, BioMarin has been in turmoil. Over the past nine months, there have been layoffs, executive restructuring, spending cuts, and research projects on hold. With the reshuffle of the business structure and the arrival of new competition, it remains to be seen when BioMarin will be able to get out of this ...
- Source: drugdu
- 88
- October 14, 2024

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