Pharma giant AstraZeneca will spend $26.5 million to build a new production line for its diabetes treatments dapagliflozin and metformin hydrochloride at the Taizhou National Medical High-tech Development Zone in Jiangsu, China Daily reports. The facility is forecast to have an annual output value of $1.4 billion and is expected to become a global manufacturing outpost for the company’s diabetes therapies, according to the publication. Marketed in the U.S. as Farxiga, dapagliflozin helps prevent absorption of glucose in the kidneys to help lower blood sugar. Metformin, meanwhile, reduces the absorption of sugar from the stomach. As a combination therapy, the medicines are marketed as Xigduo. Fierce Pharma Manufacturing has reached out to AstraZeneca for additional details on the project. AstraZeneca’s operations in China were the focus of market speculation last summer when the Financial Times reported that the company had explored separating its business in the country amid increasing geopolitical ...
Mike Hollan The company also announced that it has submitted its new glucose monitoring system to the FDA for approval. Dexcom announced that the company’s revenue for the fourth quarter of 2023 is expected to be at least $1.03 billion in a presentation at the JP Morgan Healthcare Conference. These numbers are preliminary and unaudited. This revenue would be a 26% over the earnings of the same quarter in the previous year. Similarly, the preliminary and unaudited revenue for the fiscal year 2023 is expected to $3.62 billion. Dexcom is a San Diego-based company that develops, manufactures, and sells continuous glucose monitoring systems for diabetes. In a press release, Dexcom’s chairman, president, and CEO Kevin Sayer said, “Dexcom had an incredible year in 2023 with the largest expansion of coverage in our company’s history, a successful rollout of Dexcom G7 in the U.S. and expansion of G7 to more than ...
The US Food and Drug Administration (FDA) released an update on its evaluation of suicidal risk related to glucagon-like peptide-1 receptor agonists (GLP-1 RAs). The agency did not find a clear link to suicidal risk through a review of reports of suicidal thoughts or actions received in the FDA Adverse Event Reporting System agency (FAERS) and a meta-analysis of GLP-1 RA clinical trials. Looking at FAERS data, regulators found that reported incidents were often limited in the information provided and did not offer enough evidence to determine a clear relationship with GLP-1 RA use. Furthermore, the large outcome studies and observational studies showed no association between suicidal thoughts or actions and the use of the drug class. Despite this, the agency said that due to the small number of suicidal ideation cases, it would not yet definitively rule out a potential link with GLP-1RA use. The FDA will share its ...
Recently, Hengrui Pharmaceuticals’ subsidiary Shandong Shengdi Pharmaceutical Co., Ltd. received the Certificate of Drug Registration approved for issuance by the State Drug Administration, approving the company’s self-developed Hengrui Pharmaceuticals Metformin Extended-Release Tablets (I) (II) (Ruicinda®) for marketing, which, together with dietary control and exercise, is applicable to adult patients with type 2 diabetes mellitus (T2DM) who are suitable for receiving treatment with Hengrui Pharmaceuticals and Metformin, in order to improve the glycemic control of such patients. This marks the successful launch of China’s first self-developed sodium-glucose cotransporter protein 2 inhibitor (SGLT2i) combined with metformin in a fixed-complex, extended-release formulation, which will bring more convenience to T2DM patients in China. Diabetes mellitus has become the third chronic disease that seriously endangers human health after tumor and cardiovascular disease. At present, China has become the first country with diabetes, in which patients with type 2 diabetes mellitus (T2DM) have a progressive decline ...
Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for the quality, efficacy, and safety of new drug therapies. By DAVID BLACKMAN Clinical research is in the midst of a data explosion, and that’s a good thing. Technological advances are enabling access to secure and de-identified data sources for researchers, and the optimization of this data holds enormous potential for conducting clinical trials more efficiently, both from a cost and timeline perspective. The incorporation of real-world data (RWD), data gathered from actual patient experiences, in many ways represents an important step toward a fundamentally better understanding of states of disease and health. Biomarkers, electronic health records (EHR), genomic data, imaging data, labs, social media, wearable sensors, and more provide enormous new sources of RWD that can aid in new discoveries for ...
BY SEAN WHOOLEY The Omnipod 5 hybrid closed-loop insulin delivery system worn on the back of an arm. [Image courtesy of Insulet] Insulet (Nasdaq:PODD) supports new National Institute for Health and Care Excellence (NICE) guidance supporting automated insulin delivery for type 1 diabetes. NICE published guidance recommending hybrid closed-loop systems for eligible people with type 1 diabetes in England and Wales. Hybrid closed-loop systems, like the Insulet Omnipod 5, deliver insulin automatically based on calculations from glucose monitors. Medtronic, Tandem Diabetes Care and Beta Bionics also compete with Insulet in the automated insulin delivery space. Medtronic applauded automated insulin delivery recommendations from NICE last month. NICE’s guidance, published this week, outlines that the systems require less input from the user, but manual insulin dosing is still needed sometimes, for example, around mealtimes. So, they may reduce the mental burden and improve people’s quality of life. In a LinkedIn post from ...
Recently, Fosun Diagnostics announced that its fully automated chemiluminescence immunoassay analyzer, F-i1000, has received approval for EU IVDR CE registration. The issuance of the registration certificate under the IVDR regulation signifies international recognition of the quality of Fosun Diagnostics’ chemiluminescence products and the ability to meet diverse testing requirements for projects in various levels of medical institutions such as hospitals, core laboratories, and clinics, both domestically and internationally. CE certification is granted based on relevant EU laws, regulations, and standards, serving as a passport for products to freely circulate in the EU market. On May 5, 2017, the EU released the In Vitro Diagnostic Medical Devices Regulation (IVDR) (Regulation (EU) 2017/746), replacing the original EU In Vitro Diagnostic Medical Devices Directive (IVDD, Directive 98/79/EC). After the transition period following the regulation’s implementation, in vitro diagnostic medical devices without IVDR CE certification will no longer be allowed to enter the EU ...
Tonghua Dongbao Pharmaceutical Co., Ltd. (hereinafter referred to as “the Company” or “Tonghua Dongbao”), a wholly-owned subsidiary Dongbao Zixing (Hangzhou) Biopharmaceutical Co., Ltd., received the approval notice for the clinical trial of injectable THDBH120 (GLP-1/GIP dual receptor agonist) from the National Medical Products Administration Drug Evaluation Center. The company has initiated the Phase I clinical trial and recently completed the enrollment of the first subject. After the approval for clinical use of injectable THDBH120, the company completed the enrollment of the first subject in the Phase I clinical trial in just around half a month, showcasing the company’s accelerated progress in the research and development of innovative products, as well as its ability and determination to transition into an innovative pharmaceutical enterprise. The company will further explore and uncover the potential of injectable THDBH120 in other indications such as obesity, continually opening up new therapeutic areas to maximize the value ...
Pharmaceutical Executive Editorial Staff In clinical trials, Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) produced a statistically significant improvement in survival compared to platinum-based chemotherapy alone in patients with locally advanced or metastatic urothelial cancer. Image credit: Olivier Le Moal | stock.adobe.com The FDA has approved Padcev (enfortumab vedotin-ejfv; Astellas Pharma and Seagen [now owned by Pfizer]) plus Keytruda (pembrolizumab; Merck) for patients with locally advanced or metastatic urothelial cancer (la/mUC).1 The FDA previously granted the application with priority review and breakthrough designation. The efficacy of the combination was evaluated in the open-label, randomized EV-302/KN-A39 (NCT04223856) trial, which enrolled 886 patients with la/mUC who received no prior systemic therapy for advanced disease. Patients were randomly assigned 1:1 to receive either Padcev with Keytruda or platinum-based chemotherapy consisting of gemcitabine with either cisplatin or carboplatin. The trial’s major efficacy outcomes were overall survival (OS) and progression-free survival (PFS) as assessed by blinded ...
Sanofi, which markets the two primary treatments for Pompe disease, was trying to add a third one by licensing rights to a Maze Therapeutics drug candidate with a different therapeutic approach. A Federal Trade Commission complaint alleges the deal amounts to a monopoly player taking out its competition. By FRANK VINLUAN Sanofi is walking away from a deal to license an experimental Maze Therapeutics drug for a rare enzyme deficiency after the Federal Trade Commission challenged the transaction as anti-competitive. The French pharmaceutical giant already markets Lumizyme and Nexviazyme for the disorder, called Pompe disease. Until this year, they were the only available Pompe treatments. In an administrative complaint filed Monday, the anti-trust regulator said Sanofi’s deal for Maze’s drug candidate amounts to a large company trying to eliminate a smaller competitor. Both Sanofi and Maze disagree with the FTC’s position. South San Francisco-based Maze said it is reviewing its ...
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