Recently, the Q3 financial reports of MNCs have been released one after another, and some are happy and some are sad. When a number of MNCs began to lower their full-year EPS, Amgen’s Q3 financial report earnings gave a high score answer sheet. Among them, Amgen’s total revenue in the third quarter increased by 23%, and its GAAP net earnings per share (EPS) increased by 62% year-on-year, from US$3.22 to US$5.22. What is more imaginative is that with the data catalysis of the new macromolecular weight loss drug AMG133, this macromolecular antibody that goes against the grain and antagonizes GIPR may become Amgen’s next gold mine. According to Amgen’s Q3 2024 financial report, the most significant year-on-year growth is LUMAKRAS (AMG510) – a targeted drug for KRASG12C mutation-positive lung cancer. The sales ceiling of this gene mutation in European and American countries will be much higher than that in Asian ...
Novo Nordisk recently partnered with 10 Indian artificial intelligence (AI) startups, marking an important moment for the Indian AI ecosystem. The Danish company, best known for its weight loss drug Wegovy, is leveraging AI innovations to streamline operations and improve efficiency. The moves are part of the Danish drugmaker’s expansion plans for operations in Bangalore, which it opened 17 years ago. The center helps manage the vast amounts of data collected about the safety and effectiveness of its drugs, including clinical trial information and reports of potential side effects. One of the factors driving the move is that demand for obesity and diabetes-related drugs is expected to grow, especially as global attention to these health issues grows. By strategically positioning itself in India, one of the world’s largest markets for diabetes drugs, Novo Nordisk expects to meet the growing demand by increasing its production capacity. The partnership also has a ...
These measures are part of the business expansion plan launched by this Danish pharmaceutical company in Bangalore 17 years ago. The center helps manage a large amount of data collected regarding the safety and efficacy of its drugs, including clinical trial information and potential side effect reports. One of the factors driving this initiative is that the demand for obesity and diabetes related drugs is expected to grow, especially with the increasing global attention to these health problems. Through strategic positioning in India (one of the world’s largest diabetes drug markets), Novo Nordisk is expected to meet the growing demand by improving its production capacity. This partnership has also had a broader impact on the operations of Novo Nordisk. It is expected that Novo Nordisk’s Bangalore center will become an approximate mirror of its Danish headquarters within three years. The company plans to increase the number of employees in Bangalore ...
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 ...
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 ...
On September 29, 2024, two acceptance numbers for Junshi Biosciences’s PCSK9 antibody marketing application were notified, indicating that they have not been approved (possibly due to voluntary withdrawal or pending approval). In April 2023, Junshi Biosciences received 4 acceptance numbers for its PCSK9 antibody market application, of which 2 were notified this time, and the other 2 have not yet received results. Four acceptance numbers involve two specifications (pre filled syringes, pre filled automatic syringes) and two indications. This two notifications indicate that a certain specification or indication has not been approved. The competition for PCSK9 targets is particularly fierce. In addition to antibodies from Amgen and Sanofi, PCSK9 antibodies from Sinovac Biotech and PCSK9 siRNA from Novartis have already been approved for marketing. Among them, Novartis’ PCSK9 siRNA only needs to be administered once every six months. For this target, there are more differentiated products under development, including Merck’s ...
Recently, well-known industry media Endpoint News released the “Biopharma’s Most Exciting Startups in 2024” list, which includes 11 biotechnology companies. These emerging research fields include gene editing, immunotherapy, antibody conjugated drugs (ADCs), weight loss therapy, and multiple other directions. This article will introduce these 11 rising stars (listed in no particular order) to readers, based on this ranking and official information from various companies. Lifordi Immunotherapies is a biotechnology company dedicated to developing ADC therapies for the treatment of autoimmune and inflammatory diseases. Lifordi was founded in 2023 and has secured $70 million in Series A funding from ARCH Venture Partners, 5AM Ventures, and Atlas Venture, with the goal of advancing the main candidate drug LFD-200 into clinical trials and obtaining preliminary data by the end of 2025. Lifordi’s main ADC therapy LFD-200 targets myeloid cells and lymphocytes by targeting highly internalized cell surface facial mask proteins. This therapy has ...
On September 6, GlaxoSmithKline (GSK) announced that its Phase 3 MATINEE study of its IL-5 antibody Nucala (mepolizumab) in the treatment of COPD achieved positive results. Compared with the placebo group, the Nucala treatment group achieved a statistically significant reduction in the annualized rate of moderate to severe exacerbations, but specific data have not yet been released. Two months ago, two COPD drugs with new mechanisms: ensifentrine and dupilumab were approved for marketing in the United States and Europe, refreshing the treatment model of this severe respiratory disease. Mepolizumab is expected to join this new round of competition. COPD: The third leading cause of death in humans Chronic obstructive pulmonary disease (COPD), referred to as COPD, is a common, preventable and treatable heterogeneous disease. According to statistics from the World Health Organization, COPD has become the third leading cause of death in humans, with about 11% of people dying from ...
On September 5, Connect (Nasdaq: CNTB), a global clinical-stage biopharmaceutical company headquartered in the United States, announced its financial results for the six months ended June 30, 2024 and announced plans to large-scale attrition. In addition, as part of Connect’s transformation into a U.S.-focused company, the company plans to significantly reduce the scale of its operations in China. Just a few months ago, Connect was an innovative pharmaceutical company in China. All these changes are rooted in the clinical setbacks of Connect’s core pipeline product, Rademikibart (CBP-201). This is a fully human monoclonal antibody targeting IL-4Rα, which is a common subunit of IL-4Rα and IL-13 receptors. It directly targets Sanofi’s new autoimmune drug Duprilumab. anti. In the CBP-201 clinical data previously announced by Connect, although some connotations of long-term efficacy data were seen, the improvement in the 16-week data was weaker than that of dupilumab; in addition, because it was ...
It looks like Lexicon Pharmaceuticals’ second bid to get US Food and Drug Administration (FDA) approval for Zynquista (sotagliflozin) will be as arduous as the first go around, as the regulatory agency has convened an advisory committee (AdComm) to evaluate its efficacy. The FDA’s Endocrinologic and Metabolic Drugs AdComm will discuss the benefit/risk profile of Zynquista as an adjunct to insulin therapy for glycaemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD). The AdComm is set to meet on 31 October 2024. Lexicon added that convening of the AdComm will not affect the Prescription Drug User Fee Act (PDUFA) goal date of 20 December 2024 set by the FDA. An AdComm is convened upon request of the FDA to review and evaluate the safety and efficacy data of a therapy. However, the AdComm recommendations are non-binding, with the final decision made by the FDA. The ...
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