Search Results for “EC” – Page 215 – media

Bayer Looks to Expand Kerendia’s Label to Heart Failure After Phase 3 Win

Bayer reported a Phase 3 test of Kerendia in heart failure led to statistically significant reductions in cardiovascular death and hospitalizations. Detailed results will be presented during the European Society of Cardiology annual meeting in September. By Frank Vinluan Bayer’s Kerendia, already FDA approved in one cardiometabolic indication, now has data from a pivotal test that support expanding the drug’s label to heart failure. In preliminary results reported Monday, Bayer said Kerendia reduced cardiovascular death and hospitalizations in heart failure patients, meeting the main goal of the Phase 3 clinical trial. The company did not release specific figures detailing the reductions, but said it will present the clinical data next month during the European Society of Cardiology Congress, which will be held in London. Bayer added that it plans to meet with the FDA to discuss a submission seeking regulatory approval for the drug in heart failure. Kerendia is a small ...
- Source: drugdu
- 64
- August 7, 2024
KOREA PHARM & BIO

Organiser：KOREA PHARM & BIO Time：April 22nd – 25th, 2025 address：217-59 Kintekseu-ro, Daehwa-dong, Ilsanseo-gu, Goyang-si, Gyeonggi-do, Korea Exhibition hall：KINTEX Product range: Pharmaceuticals: Pharmaceutical Raw Materials, Active Pharmaceutical Ingredients (APIs), Pharmaceutical Fine Chemicals, Intermediates, Pharmaceutical Additives, Pharmaceutical Dosage Forms, Natural Extracts, Biotechnology, Pharmaceutical Outsourcing and Services, Laboratory Equipment, Pharmaceutical Manufacturing Equipment, etc. Chemicals: Chemical Raw Materials, Chemical Equipment, Instrumentation, Automation Control Technology, Heat Exchangers, Crystallization, Gas Absorption, Drying, Filtration, Centrifugal Separators, Dust Collection, Chemical Reactors, Crushers, Mixers, etc. Cosmetics: Cosmetic Raw Materials, Cosmetic Additives, Functional Materials, Natural Extracts, etc. About KOREA PHARM & BIO： KOREA PHARM & BIO is one of the most influential pharmaceutical and biotechnology exhibitions in Korea and Asia. It is jointly organized by the Korea Food and Drug Administration (KFDA), Korea Pharmaceutical Manufacturers Association (KPMA), and Kyungyon Exhibition Company in Korea.
- Source: drugdu
- 115
- August 7, 2024
【EXPERT Q&A】What do regulatory and non-regulatory markets mean?

Drugdu.com expert’s response: Drug regulatory market and non-regulatory market are two relative concepts, and they have significant differences in the regulation, production and sale of drugs. Ⅰ. Pharmaceutical Regulatory Market The pharmaceutical regulatory market can be understood as one that adheres to the standards and guidelines set forth by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). These markets typically operate under stringent legal and regulatory frameworks, imposing rigorous oversight on drug research and development, production, and sales. Specifically, the pharmaceutical regulatory market necessitates that drugs comply with relevant quality and safety standards and undergo rigorous approval processes before being marketed and sold. In such markets, government regulatory authorities rigorously supervise and manage drugs to ensure their quality and safety. Ⅱ. Unregulated Market The unregulated market, on the other hand, refers to markets that operate in violation of local laws and regulations. These markets ...
- Source: drugdu
- 89
- August 7, 2024
WuXi Biologics’ Four Manufacturing Facilities and Biosafety Testing Center Certified Again by European Medicines Agency for Ten Biologics

WUXI and SUZHOU, China, Aug. 1, 2024 /PRNewswire/ — WuXi Biologics (“WuXi Bio”) (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that four manufacturing facilities and Suzhou Biosafety Testing Center in China have received Good Manufacturing Practice (GMP) certificates from the European Medicines Agency (EMA), demonstrating the company’s commitment to meeting rigorous international industry quality standards across its global network. Following comprehensive inspections of the company’s facilities– specifically MFG1, MFG2, MFG5, and DP1 in Wuxi– EMA GMP certificates were issued for commercial and New Drug Application (NDA)-ready manufacturing and services for eight biologics, an endorsement to the company’s capabilities in providing such services for global clients. All of these facilities were previously approved by the EMA and other major regulatory authorities for the development of multiple biologic therapeutics. Furthermore, the company’s Suzhou Biosafety Testing Center was once again certified by the EMA to provide services ...
- Source: drugdu
- 75
- August 6, 2024
Researchers reveal CAR-enhancer therapy could help overcome cancer relapse

Cancer is estimated to affect more than three million people living in the UK, according to Macmillan Cancer Support Researchers from the Dana-Farber Cancer Institute have revealed in a study that CAR-enhancer (CAR-E) therapy could help patients overcome cancer relapse. In the findings published in Nature Biotechnology, researchers report on a technique to prevent relapse and researchers hope to launch the first trial in the near future. It is estimated that there are more than three million people living in the UK with cancer, according to Macmillan Cancer Support, with breast cancer being the most prevalent, accounting for more than 55,000 new cases every year. A common challenge faced when using CAR T-cell therapies is that many patients, including those whose cancer has gone into full remission, eventually relapse. To eliminate this problem, the new techniques create what researchers consider a CAR-E therapeutic platform, which causes CAR T cells to ...
- Source: drugdu
- 103
- August 6, 2024
Otsuka Commits $800M in M&A Deal Bringing a Phase 3-Ready Metabolic Disorder Drug

Otsuka Pharmaceutical is acquiring Jnana Therapeutics, whose lead drug is a potential treatment for the rare metabolic disorder phenylketonuria (PKU). Jnana’s drug could provide an alternative to two FDA-approved PKU medicines from BioMarin Pharmaceutical. By Frank VinluanOtsuka Pharmaceutical is broadening its scope in rare disease, striking a deal to acquire Jnana Therapeutics and its lead drug candidate, a small molecule on track for pivotal testing in a metabolic disorder with few treatments. Per deal terms announced Thursday, Otsuka is paying $800 million up front to buy Boston-based Jnana. The Japanese pharma company could shell out up to $325 million more if the lead drug candidate of privately held Jnana achieves development and regulatory milestones. Jnana’s lead program, JNT-517, is in development for phenylketonuria (PKU), an inherited disorder that leads to deficiency of an enzyme needed to break down phenylalanine, an amino acid found in certain foods. Buildup of phenylalanine in ...
- Source: drugdu
- 80
- August 5, 2024
Tirzepatide Shows Statistically Significant Improvements in Reducing Heart Failure Risk, Enhanced Symptoms

By Don Tracy, Associate Editor Data from the SUMMIT clinical trial demonstrated that tirzepatide lowered the risk of negative heart failure outcomes and enhanced symptoms and physical limitations when tested with three different doses. Results from the SUMMIT Phase III clinical trial found that Eli Lilly’s tirzepatide, tested at doses of 5 mg, 10 mg, and 15 mg, showed statistically significant improvements in reducing heart failure with preserved ejection fraction (HFpEF) and obesity, as measured by the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS), compared to placebo. According to the company, tirzepatide also demonstrated improved exercise capacity as measured by the 6-Minute Walk-Test Distance (6MWD), reduction in the inflammation marker high-sensitivity C-reactive protein (hsCRP), and a noteworthy mean body weight reduction at 52 weeks.1 “HFpEF accounts for nearly half of all heart failure cases, and in the U.S. almost 60% of those impacted also live with obesity.1,2 Despite ...
- Source: drugdu
- 68
- August 5, 2024
Innovative Imaging Method to Revolutionize Microscopy

Currently, scanning transmission electron microscopes (STEMs) employ a highly focused electron beam that traverses a sample, creating images point by point. Traditionally, at each point, the beam pauses for a constant, predetermined duration to gather signals, akin to how cameras with photographic film function, resulting in uniformly exposed images across all areas. This method continuously exposes the sample to electrons until the set “dwell-time” for each pixel elapses. Although simple to implement, this technique can subject the sample to excessive radiation, potentially altering or destroying it. Now, a pioneering imaging technique utilizing advanced microscopes has significantly reduced the time and radiation needed for imaging. This advancement is particularly beneficial for fields like medicine, where it promises enhanced imaging of sensitive materials, such as biological tissues, which are highly susceptible to damage. The new method, devised by an international research group led by Trinity College Dublin (Dublin, Ireland), fundamentally rethinks the ...
- Source: drugdu
- 66
- August 5, 2024
Sanofi invests $1.4bn in insulin production in Germany

Sanofi has announced a significant investment of €1.3bn ($1.4bn) to increase its insulin production capabilities with an expanded facility in Frankfurt, Germany. The facility will cover 36,000m² at Sanofi’s existing BioCampus site and become operational in 2029. Sanofi will execute the project with support from the German national government and the Hesse state government, subject to European Union approval. Sanofi manufacturing and supply global head Brendan O’Callaghan stated: “With this project, we reaffirm our commitment to help diabetes sufferers around the world. “We’re using the long-time expertise of our Frankfurt BioCampus and its highly qualified personnel.” The investment comes in the wake of the German government’s adoption of an official pharma strategy in 2023 to bolster support for pharmaceutical companies. The approach also aids in streamlining approval processes and enhances conditions for research and development within the country. Sanofi Germany chairman Heidrun Irschik-Hadjieff said: “Our planned investment underscores the central ...
- Source: drugdu
- 65
- August 5, 2024
Rejuvenate and SAS partner to harness AI for age-related diseases

Belgian biotech Rejuvenate Biomed has teamed up with data and AI solutions company SAS to create a tool for researchers to repurpose existing drugs to tackle age-related diseases at their core. The low-code tool aims to simplify the process of analysing biomedical data. It will use SAS’s analytics to reveal hidden biological patterns and interactions, allowing researchers to create detailed reports with SAS visual analytics. The tool will be built on SAS Viya, a cloud-based AI and data platform. According to the companies, the tool is designed to be user-friendly for researchers who don’t have a wealth of coding experience but will also be powerful enough for advanced teams working on complex biological problems. Founded in 2017, Rejuvenate raised €15.7m ($16.9m) in a Series B round led by Zürich-based biotech Rejuveron Life Sciences in 2021. The funds built on a €3.2m ($3.46m) Series A in the same year. The start-up ...
- Source: drugdu
- 84
- August 5, 2024

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