Live Breaking News & Updates on Regulatory agency

Stay informed with the latest breaking news from Regulatory agency on our comprehensive webpage. Get up-to-the-minute updates on local events, politics, business, entertainment, and more. Our dedicated team of journalists delivers timely and reliable news, ensuring you're always in the know. Discover firsthand accounts, expert analysis, and exclusive interviews, all in one convenient destination. Don't miss a beat — visit our webpage for real-time breaking news in Regulatory agency and stay connected to the pulse of your community

Trial date set for four men and woman accused of selling prescription medicine illegally online

Trial date set for four men and woman accused of selling prescription medicine illegally online
expressandstar.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from expressandstar.com Daily Mail and Mail on Sunday newspapers.

Willenhall , Walsall , United-kingdom , Regulatory-agency , Wolverhampton-crown-court-on , Criminal-enforcement-unit , Wolverhampton-crown-court ,

AMGEN TO SUBMIT TEPROTUMUMAB MARKETING AUTHORIZATION APPLICATION TO THE EUROPEAN MEDICINES AGENCY

/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the imminent submission of a Marketing Authorization Application (MAA) to the European Medicines Agency...

Puerto-rico , Saudi-arabia , Brazil , United-states , Japan , Milano , Lombardia , Italy , Australia , Canada , United-kingdom , Great-britain

AMGEN TO SUBMIT TEPROTUMUMAB MARKETING AUTHORIZATION APPLICATION TO THE EUROPEAN MEDICINES AGENCY

AMGEN TO SUBMIT TEPROTUMUMAB MARKETING AUTHORIZATION APPLICATION TO THE EUROPEAN MEDICINES AGENCY
marketscreener.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from marketscreener.com Daily Mail and Mail on Sunday newspapers.

Canada , Australia , Milano , Lombardia , Italy , United-kingdom , Brazil , Saudi-arabia , Puerto-rico , Japan , United-states , Kingdom-of-saudi-arabia

Santhera Announces Preliminary Unaudited 2023 Annual Results and Provides Corporate Update Ahead of Full Report Publication in May

Ad hoc announcement pursuant to Art. 53 LR A conference call will be held on April 25, 2024, at 14:30 CEST / 13:30 BST / 08:30 EDT. Details are at the end of this news release. Santhera Announces Preliminary Unaudited 2023 Annual Results and Provides Corporate Update Ahead of Full Report Publication in May 2023 financial key figures: Revenue from contracts with customers of CHF 103.4 million (2022: CHF 7.5 million) Net result of CHF 54.8 million (2022: CHF -71.1 million) Cash flow from operating

Italy , United-states , Highbridge , Somerset , United-kingdom , Spain , Pratteln , Switzerland-general- , Switzerland , France , Austria , China

Sage Therapeutics Announces First Quarter 2024 Financial Results and Highlights Pipeline and Business Progress

Sage Therapeutics Announces First Quarter 2024 Financial Results and Highlights Pipeline and Business Progress
streetinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from streetinsider.com Daily Mail and Mail on Sunday newspapers.

Cambridge , Cambridgeshire , United-kingdom , Matthew-henson , Barry-greene , Ashley-kaplowitz , National-pregnancy-registry-for-antidepressants , Sage-therapeutics-inc , European-medicines-agency , Biogen-inc , Nasdaq , Regulatory-agency

Effect of combination treatment with glucagon-like peptide-1 receptor agonists and sodium-glucose cotransporter-2 inhibitors on incidence of cardiovascular and serious renal events: population based cohort study

Objective To determine whether the combined use of glucagon-like peptide-1 (GLP-1) receptor agonists and sodium-glucose cotransporter-2 (SGLT-2) inhibitors is associated with a decreased risk of major adverse cardiovascular events and serious renal events compared with either drug class alone among patients with type 2 diabetes, and to assess the effect of the combination on the individual components of major adverse cardiovascular events, heart failure, and all cause mortality.

Design Population based cohort study using a prevalent new-user design, emulating a trial.

Setting UK Clinical Practice Research Datalink linked to Hospital Episode Statistics Admitted Patient Care and Office for National Statistics databases.

Participants Two prevalent new-user cohorts were assembled between January 2013 and December 2020, with follow-up until the end of March 2021. The first cohort included 6696 patients who started GLP-1 receptor agonists and added on SGLT-2 inhibitors, and the second included 8942 patients who started SGLT-2 inhibitors and added on GLP-1 receptor agonists. Combination users were matched, in a 1:1 ratio, to patients prescribed the same background drug, duration of background drug, and time conditional propensity score.

Main outcome measures Cox proportional hazards models were fitted to estimate the hazard ratios and 95% confidence intervals of major adverse cardiovascular events and serious renal events, separately, comparing the GLP-1 receptor agonist-SGLT-2 inhibitor combination with the background drug, either GLP-1 receptor agonists or SGLT-2 inhibitors, depending on the cohort. Secondary outcomes included associations with the individual components of major adverse cardiovascular events (myocardial infarction, ischaemic stroke, cardiovascular mortality), heart failure, and all cause mortality.

Results Compared with GLP-1 receptor agonists, the SGLT-2 inhibitor-GLP-1 receptor agonist combination was associated with a 30% lower risk of major adverse cardiovascular events (7.0 v 10.3 events per 1000 person years; hazard ratio 0.70, 95% confidence interval 0.49 to 0.99) and a 57% lower risk of serious renal events (2.0 v 4.6 events per 1000 person years; hazard ratio 0.43, 0.23 to 0.80). Compared with SGLT-2 inhibitors, the GLP-1 receptor agonist-SGLT-2 inhibitor combination was associated with a 29% lower risk of major adverse cardiovascular events (7.6 v 10.7 events per 1000 person years; hazard ratio 0.71, 0.52 to 0.98), whereas serious renal events generated a wide confidence interval (1.4 v 2.0 events per 1000 person years; hazard ratio 0.67, 0.32 to 1.41). Secondary outcomes generated similar results but with wider confidence intervals.

Conclusions In this cohort study, the GLP-1 receptor agonist-SGLT-2 inhibitor combination was associated with a lower risk of major adverse cardiovascular events and serious renal events compared with either drug class alone.

This study is based on data from the Clinical Practice Research Datalink obtained under license from the UK Medicines and Healthcare products Regulatory Agency. The data are provided by patients and collected by the UK National Health Service as part of their care and support. The interpretation and conclusions contained in this study are those of the authors alone. Because electronic health records are classified as “sensitive data” by the UK Data Protection Act, information governance restrictions (to protect patient confidentiality) prevent data sharing via public deposition. Data are available with approval, through the individual constituent entities controlling access to the data. Specifically, the primary care data can be requested via application to the Clinical Practice Research Datalink (<https://www.cprd.com>).

United-kingdom , Bristol , City-of , Montreal , Quebec , Canada , Canadian , British , Canadian-institutes-of-health-research , Novartis , Setting-united-kingdom-clinical-practice-research-datalink

Alectinib: Adjuvant Treatment for Lung Cancer Approved by US FDA

Alectinib approved by US FDA for auxiliary treatment of patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who underwent tumor resection.

Israel , United-kingdom , Canada , Australia , Australian , Israel-ministry-of-health , Australian-therapeutic-goods-administration , Genentech-inc , Drug-administration-on , Regulatory-agency , Oncology-center