Search Results for “FDA” – Page 87 – media

1.5 billion US dollars! Capricor Therapeutics partners with Nippon Pharmaceutical Co., Ltd

Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. On September 17, 2024, Capricor Therapeutics, a biotechnology company developing transformed cell and exosome therapies for the treatment of rare diseases, announced that it had signed a binding term sheet with Nippon Pharma. The terms state that Nippon Pharma will commercialize and distribute Capricor’s main asset, deramiocel, in Europe for the treatment of Duchenne muscular dystrophy (DMD). Capricor will receive a $15 million equity investment at a 20% premium and a $20 million advance payment upon signing the final agreement. The potential milestone amount is as high as $715 million, with product revenue accounting for double digits. The total ...
- Source: drugdu
- 56
- September 19, 2024
Chinese non-opioid long-acting analgesics “break through one after another”

Recently, Kelun Pharmaceutical announced that its subsidiary Hunan Kelun Pharmaceutical’s chemical drug “Bupivacaine Liposome Injection” was approved for marketing by the National Medical Products Administration (trade name Bruco®), which was approved according to Class 3 chemical drugs and deemed to have passed the generic drug quality and efficacy consistency evaluation. Kelun Pharmaceutical’s Bruco® is the second bupivacaine liposome injection product to be launched in China. Hengrui Medicine’s bupivacaine liposome injection generic drug (trade name: Aihengping) was approved in November 2022. It is the world’s first generic drug and also the first long-acting postoperative analgesic drug to be launched in China. In July this year, Aihengping was approved for marketing by the FDA, becoming the world’s first manufacturer to obtain generic drug approval for this variety in the United States. Behind the successful breakthroughs of domestic pharmaceutical companies is the growing market demand in the field of long-acting postoperative analgesic preparations ...
- Source: drugdu
- 58
- September 19, 2024
$1.8 billion! Lilly builds factory and expands GLP-1 production

Disclaimer: Due to limited proficiency, errors are inevitable, or some information may not be timely. Please feel free to leave a message to indicate. This article only provides an introduction to medical and health-related drugs, and does not recommend treatment plans (if applicable); This article does not constitute any investment advice. Lilly said that the company had completed the $800 million Kinsale factory expansion project to increase the production of its obesity and diabetes drugs Mounjaro and Zepbound. At the same time, the pharmaceutical company will also invest $1 billion to build a factory in Limerick to increase the production of biopharmaceutical raw materials, especially Kisunla, a drug approved by the FDA to treat Alzheimer’s disease two months ago. The production of active pharmaceutical ingredients is expected to begin in 2026. Lilly stated that Limerick’s expansion will add tools for artificial intelligence, automated robots, and machine learning to the website. ...
- Source: drugdu
- 73
- September 16, 2024
WHO approves first mpox vaccine to boost access in Africa

The MVA-BN vaccine from the Danish pharmaceutical company Bavarian Nordic was prequalified by the WHO on Friday and has already been approved in Europe and the United States, for use by adults. WHO approval will accelerate access for millions, to reduce transmission and help contain the outbreak. WHO’s Director-General, Tedros Adhanom Ghebreyesus said the prequalification of this vaccine is an important step in the fight against the mpox virus in Africa and for the future. “We now need urgent scale up in procurement, donations and rollout to ensure equitable access to vaccines where they are needed most, alongside other public health tools, to prevent infections, stop transmission and save lives,” Mr. Ghebreyesus said. The MVA-BN vaccine can be given in two doses to people 18 years and older, four weeks apart, which has an estimated 82 per cent effectiveness. For infants, young children, pregnant women and immunocompromised people, the vaccine ...
- Source: drugdu
- 65
- September 16, 2024
After CXO, will the United States start to take action against Chinese APIs?

In response to whether the bill is feasible, the FDA once said, “If there is not enough data to calculate which APIs come from China, what proportion and how much impact, no one can guarantee that there will not be fatal drug shortages, and no one is willing to take such responsibility.” Now, the API industry base survey and assessment initiated by the U.S. Department of Commerce is a comprehensive survey of industry data, which means possible variables in the future. According to reports, in July this year, the Bureau of Industry and Security (BIS) of the U.S. Department of Commerce officially announced that it would cooperate with the Strategic Preparedness and Response Administration (ASPR) under the U.S. Department of Health and Human Services (HHS) to conduct a comprehensive investigation and assessment of the U.S. active pharmaceutical ingredients, or API industry base. The survey aims to understand the supply chain ...
- Source: drugdu
- 47
- September 16, 2024
The light of domestic production! Kangnuo’s IL-4R α antibody drug has been approved for market by NMPA

On September 12th, Konya announced that the company’s independently developed Class 1 new drug, Kangyueda ® (Sipuximab Injection) has been officially approved for marketing by the National Medical Products Administration for the treatment of moderate to severe atopic dermatitis in adults. As the first domestic and second globally approved IL-4R alpha antibody drug, Kangyueda ® The launch of Sipuqibai monoclonal antibody not only fills the gap in the field of domestic atopic dermatitis biologics, but also brings new hope for patients with moderate to severe atopic dermatitis to achieve higher treatment goals. Kangyueda ® (Sprucubizumab) Kangyueda ® The Phase III clinical trial of (Sipuximab) is the largest randomized controlled trial of dermatological subjects completed in China to date. The research results show that, The first dose takes effect quickly: Kangyueda ® The first dose of single agent treatment with (Sipuximab) can quickly relieve itching symptoms within one day; After 2 ...
- Source: drugdu
- 68
- September 14, 2024
Obeticolic acid ‘fate judgment’

Since its launch in 2016, Ocaliva (obeticolic acid) has not only failed to successfully develop a new indication for MASH, but also struggled to survive in primary biliary cirrhosis (PBC), and is now facing regulatory scrutiny once again. Recently, the FDA released a pre conference briefing document questioning the effectiveness and safety of Ocaliva for PBC in its approved indications. In this briefing document, the FDA criticized two clinical studies, 747-302 and 747-405. The FDA pointed out that the 747-302 trial failed to demonstrate statistically significant benefits of Ocaliva for PBC, but instead increased the risk of liver transplantation or death in patients. For 747-405, the clinical trial did not meet sufficient and well controlled regulatory standards. Today, members of the FDA Expert Advisory Committee will vote on whether to convert it from accelerated approval to full approval. Out of NASH Ocaliva is a potent and specific agonist of ...
- Source: drugdu
- 73
- September 14, 2024
Johnson&Johnson increases investment in medical imaging

Recently, medical imaging company Spectra has completed its Series B financing and raised $50 million (approximately RMB 356 million) in funding. It is understood that the funds raised in this round of financing will support the commercial expansion and product increase of Spectra ‘Hypervue imaging system to benefit patients with coronary artery disease. It is worth noting that this round of financing is led by Johnson and Johnson Innovation and supported by investors such as S3 Ventures, Lumira Ventures, SV Health Investors, Deerfield Management, NovaVenture, and Heartwork Capital. Spectrawave， The intravascular imaging system has been approved by the FDA According to publicly available information, Spectra was founded in 2017 and is located in Massachusetts, USA. It is a medical imaging company focused on improving the treatment and prognosis of patients with coronary artery disease (CAD). The Spectral Medical Imaging Platform is the most advanced integration of mature imaging technologies, designed ...
- Source: drugdu
- 56
- September 14, 2024
Baird Medical’ successfully went public in the United States

Recently, Baird Medical’s business merger with overseas special purpose acquisition company ExcelFin Acquisition Corp. has been approved by the US SEC, and the F-4 application documents have officially come into effect, with a declaration of registration effectiveness issued. Baird Medicalhas achieved listing on the NASDAQ Stock Exchange in the United States through the merger with ExcelFin Acquisition Corp., a foreign special purpose acquisition company. In addition, Baird Medicalalso announced that ExcelFin has arranged a special shareholders’ meeting to be held on September 26, 2024. After the meeting, it is expected to receive approval from ExcelFin shareholders and the merger will be completed soon. The bumpy road falls on the eve of going public Before going public in the United States, Baird Medicalhad a bumpy road to going public in Hong Kong. Founded in 2012, Baird Medicalis a leading developer and provider of microwave ablation medical devices for minimally invasive treatment ...
- Source: drugdu
- 53
- September 14, 2024
Increasing Investment in R&D Innovation to Deepen Product Competitive Moats

CSPC Pharmaceutical Group has achieved significant milestones in research and development, securing conditional approval for its self-developed Class 1 new drug, Enlansub, and for the injectable version of Rayzoprazole. The company has also received approval for clinical trials in the U.S. for its antibody-drug conjugate, clinical trial approval for its mRNA vaccine against respiratory syncytial virus, and clinical trial approval for the first CAR-T cell injection based on mRNA-LNP technology. As an innovation-driven enterprise and a key player in the national industrial chain, CSPC continues to enhance its R&D investments, elevate its international influence, and fortify its product competitive edge. This year, various in-development drugs have reached key progress points, with some approved for market launch or clinical trials both domestically and internationally. Currently, CSPC is conducting over 130 innovative drug projects, with more than 50 new drugs expected to be launched in the next five years. Comprehensive Market Coverage ...
- Source: drugdu
- 60
- September 14, 2024

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