Search Results for “FDA” – Page 83 – media

460 million! Migraine innovative equipment company completes Series B financing

Recently, migraine innovative equipment company ShiraTronics announced the completion of a Series B financing of $66 million (approximately RMB 460 million) to support its innovative migraine treatment system. This round of financing is led by new investor Norwest Venture Partners, with other new investors including 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. The world’s first medical device to treat migraine ShiraTronics, located in Minneapolis, Minnesota, is a clinical stage medical device company dedicated to developing neurostimulation therapies for chronic migraine patients. It is committed to improving the lives of chronic migraine patients and was awarded the FDA Breakthrough Device designation in 2021. The name migraine is not unfamiliar and is often heard in daily life, so the migraine market is ...
- Source: drugdu
- 57
- 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
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
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
- 48
- 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
- 66
- 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
- 62
- October 14, 2024
Dental laser equipment boss, bankruptcy and acquisition

On October 9, 2024, Biolase, which occupies the top spot in the world’s dental laser equipment, announced that it has signed an agreement to sell the majority of the company’s assets to rival Sonendo for $14 million. Biolase Company of United States, the world’s leading oral laser expert, has long been committed to the research and development and manufacturing of full-function lasers, with a global laser market share of 70%. However, due to long-term losses, the stock price continued to be depressed, and it was delisted from the Nasdaq in June this year and declared bankruptcy on October 1. The buyer of the acquisition, Sonendo, a dental giant dedicated to root canal treatment devices, sued Biolase in 2023 for a patent dispute, claiming no less than $59 million in damages. This acquisition not only marks the end of an era for the giant Biolase, but also announces the end of ...
- Source: drugdu
- 57
- October 14, 2024
intensified BD trading competition in the pharmaceutical market, pharmaceutical companies launch market competition war

Source: 21st Century Business Herald Has the cow arrived? The A-share market is booming, don’t miss the opportunity, open an account and layout now>> Recently, there has been a frequent wave of business development (BD) cooperation transactions between Chinese and foreign pharmaceutical companies. On October 9th, Baiaotai announced that it has reached an authorization license, production, supply, and commercialization agreement with Gedeon Richter Plc. for BAT2206 (ustekinumab) injection solution. According to the agreement, Baiaotai will license the exclusive commercial rights of the injection in the EU, UK, Switzerland, Australia, and other European markets to Gedeon Richter Plc for a fee. The amount involved in this transaction includes a down payment of $8.5 million, milestone payments up to a cumulative total of $101.5 million, and revenue sharing based on a double-digit percentage of net sales. In addition to Baiaotai, several Chinese pharmaceutical companies have also recently received positive news regarding BD ...
- Source: drugdu
- 78
- October 12, 2024
Dental laser equipment leader, bankrupt and acquired

On October 9, 2024, Biolase, which dominates the global dental laser equipment market, announced that it has signed an agreement to sell most of its assets to competitor Sonendo for $14 million. Biolase, a leading dental laser expert in the world, has long been committed to the research and manufacturing of fully functional lasers, with a global laser market share of 70%. But due to long-term losses, the stock price remained low, and it was delisted from NASDAQ in June this year, and declared bankruptcy on October 1st. The buyer of this acquisition case, Sonendo, is a dental giant dedicated to root canal treatment equipment. Its subsidiary sued Biolase in 2023 for a patent dispute and demanded compensation of no less than $59 million. This acquisition not only marks the end of an era for giant Biolase, but also declares the end of the aforementioned patent dispute. 01. The world’s ...
- Source: drugdu
- 72
- October 12, 2024
intensified BD trading competition in the pharmaceutical market, pharmaceutical companies launch market competition war

October 11, 2024 09:03 Source: 21st Century Business Herald Has the cow arrived? The A-share market is booming, don’t miss the opportunity, open an account and layout now>> Recently, there has been a frequent wave of business development (BD) cooperation transactions between Chinese and foreign pharmaceutical companies. On October 9th, Baiaotai announced that it has reached an authorization license, production, supply, and commercialization agreement with Gedeon Richter Plc. for BAT2206 (ustekinumab) injection solution. According to the agreement, Baiaotai will license the exclusive commercial rights of the injection in the EU, UK, Switzerland, Australia, and other European markets to Gedeon Richter Plc for a fee. The amount involved in this transaction includes a down payment of $8.5 million, milestone payments up to a cumulative total of $101.5 million, and revenue sharing based on a double-digit percentage of net sales. In addition to Baiaotai, several Chinese pharmaceutical companies have also recently received ...
- Source: drugdu
- 72
- October 11, 2024

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