PharmaFocus Today – Page 32 – media

The Heyuan Hemei Regenerative Medicine Center has been officially established, and Heyuan Biotech is embarking on a new journey with the wind

On September 13th, as the autumn atmosphere grew stronger, the establishment ceremony of Heyuan Hemei Regenerative Medicine Center was successfully held at 3888 Canghai Road and Heyuan Intelligent Manufacturing Precision Medical Industry Base in Lingang New Area, Shanghai. At the event, all the guests gathered together to witness this milestone moment.The successful holding of the establishment ceremony of Heyuan and Hemei marks a further expansion of Heyuan Group’s business map and a solid step forward in the strategic layout of cell therapy. As a high-tech enterprise deeply involved in the fields of cell and gene therapy, Heyuan Group relies on its own nearly 5000 square meters of comprehensive research and development production platform, as well as nearly 80000 square meters of port base, to continuously accelerate the research and commercialization process of cell and gene therapy. The establishment of Heyuan Hemei Regenerative Medicine Center will help enterprises build a more ...
- Source: drugdu
- 65
- September 18, 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
- 74
- September 16, 2024
Antibody therapy receives FDA approval again

biopharmaceutical era 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 11th, Johnson&Johnson announced that the US FDA has approved Tremfya (guselkumab) for the treatment of moderate to severe active ulcerative colitis (UC) in adult patients. According to the press release, Tremfya is the first dual acting mechanism interleukin-23 (IL-23) inhibitor approved for the treatment of active ulcerative colitis. In the critical QUASAR project, the drug demonstrated a highly statistically significant endoscopic response rate. The approval of Tremfya this time is supported by data from the ongoing Phase 2b/3 QUASAR study, which evaluates the efficacy and safety of Tremfya in adult patients with moderate to severe ...
- Source: drugdu
- 61
- September 16, 2024
WHO chief hails ‘massive success’ of polio campaign amid tragic reality

WHO chief Tedros Adhanom Ghebreyesus tweeted that it had been “a massive success amidst a tragic daily reality of life” for more than two million Gazans who have been caught up in the intense fighting since last October’s terror attacks by Hamas unleashed the war in Gaza. In three phases over twelve days, from 1 to 12 September, UN agencies and partners provided novel oral polio vaccine type 2 (nOPV2) to some 558,963 children, reaching families living in shelters, tents and camps for the displaced. Tweet URL Richard Peeperkorn, WHO Representative for the occupied Palestinian territory applauded the “incredible resilience” of health and community workers in conducting the campaign “at an unprecedented scale and speed under the toughest conditions” in the war-battered enclave. “Swift action by the Global Polio Eradication Initiative – from the moment the virus was detected to the launch of the vaccination campaign – speaks to the ...
- Source: drugdu
- 63
- 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
- 77
- September 16, 2024
Milestone! Symptoms completely disappeared, dual-antibody treatment of autoimmune diseases published in the New England Journal of Medicine

Targeting B cells and plasma cells is a key strategy for treating a variety of autoimmune diseases. In recent years, chimeric antigen receptor T cell (CAR-T) therapy has made some progress in autoimmune diseases, and many patients who received CD19-targeted CAR-T therapy have achieved long-term drug-free remission. However, the long production process of this type of therapy, the need for patients to undergo pretreatment in advance, and the inability to flexibly adjust the dose of CAR-T cells after the start of treatment have limited its widespread application. In addition, for some patients, their disease may be caused by long-lived plasma cells that express B cell maturation antigen (BCMA) but not CD19. Therefore, even after receiving CD19-targeted CAR-T therapy, autoimmune antibodies such as antinuclear antibodies and polymyositis-scleroderma-associated antibodies (PM-Scl) still exist in patients. In view of the limitations of CAR-T therapy in the application of autoimmune diseases, researchers have set their ...
- Source: drugdu
- 84
- 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
- 52
- 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
- 83
- 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
- 76
- 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
- 61
- September 14, 2024

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