Search Results for “FDA” – Page 160 – media

Why Small Biotech Needs To Plan Ahead For Global Reach

If small biotech does more to plan ahead for ex-US market requirements, companies and their investors – and crucially patients – will benefit.
- Source: https://invivo.pharmaintelligence.informa.com/IV124998/Missed-Opportunities-Why-Small-Biotech-Needs-To-Plan-Ahead-For-Global-Reach
- 1,718
- April 6, 2022
biotech commercializing
Prioritize, Optimize And Modernize

Medtech’s resilience and flexibility have been clear to see during the COVID-19 pandemic. In this forward-looking view for 2022, CEOs from some of the Top 50 global medtechs share their perspectives on the present and the future, from company and health care system standpoints.
- Source: https://invivo.pharmaintelligence.informa.com/IV124946/The-PostCOVID-Mantra-For-Medtechs-Prioritize-Optimize-And-Modernize
- 819
- April 6, 2022
Health Care Transformation Modernize Post-COVID Mantra
Bayer’s Kerendia approved in the US to slow CKD in type 2 diabetes patients

Bayer’s first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) Kerendia has received approval in the US to slow chronic kidney disease (CKD) progression in patients with type 2 diabetes (T2D). The US Food and Drug Administration (FDA) has cleared Kerendia (finerenone) to reduce the risk of sustained eGFR decline, kidney failure, cardiovascular death, non-fatal myocardial infarction (MI) and hospitalisation for heart failure in adult patients with CKD associated with T2D. The approval is based on data from the Phase III FIDELIO-DKD renal outcomes study, which showed Kerendia significantly reduced the combined primary endpoint of chronic kidney disease progression, kidney failure or kidney death versus placebo when added to standard of care. The drug also lowered the risk of a composite of time to first occurrence of CV death, non-fatal myocardial infarction, non-fatal stroke or heart failure hospitalisation, thereby by also meeting secondary targets. “Kerendia is the first and only nonsteroidal mineralocorticoid receptor ...
- Source: drugdu
- 1,036
- August 26, 2021
diabetes
10 Triumphant Drug Launches Of The Decade

The view from 2020: Scrip looks back at the most successful commercial launches of the decade.
- Source: https://scrip.pharmaintelligence.informa.com/SC141426/10-Triumphant-Drug-Launches-Of-The-Decade
- 2,652
- August 26, 2021
Ddu College Market Views
The New CRISPR-Based Covid-19 Test Could Be a Game-Changer

A new test based on gene targeting technology CRISPR could diagnose Covid-19 infections in 45 minutes. It was recently outlined in a paper in the journal Nature Biotechnology.
- Source: drugdu
- 1,545
- August 26, 2021
Covid-19 Covid-19 Test gene targeting technology
China’s Import and Export Market Report of Rheumatoid Arthritis Drugs

Rheumatoid arthritis (RA) is an autoimmune disease with complex pathogenesis and an extremely high morbidity rate, which seriously affects the quality of the life of patients and brings economic burden to society. Thus, effective treatments of RA has become a global concern of the pharmaceutical industry.
- Source: Ddu
- 3,945
- August 26, 2021
Ddu College Market Reports RA
Ddu College——WHO vaccine pre-certification How to conduct effective consultation?

From November 1st to 2nd, 2018, the annual World Health Organization (WHO) Prequalification (PQ) consultation will be held in Kunming, China. Unlike previous years, this year’s consultation will only take the one-on-one format, namely the World Health Organization Vaccine Pre-Certification Review Team and small meetings of various domestic vaccine manufacturers. Although the part of the centralized consultation meeting will be cancelled, which means companies and international organizations are unable to discuss and share the importance of pre-certification, but it’s believed that after several years of consultations, everyone has already cooked up the importance and significance of pre-certification. Evidence? This year’s 14 vaccine manufacturers actively participate in the one-on-one consultation is the best proof. As of November 2018, there were 4 manufacturers and vaccines that successfully passed the pre-certification of vaccines in China, namely, Chengdu institution’s Yinao, Hualan’s Liugan, Kexing’s Miejia and Beishengyan’s bOPV. At the PQ consultation meeting in Beijing ...
- Source: drugdu
- 1,507
- August 25, 2021
Ddu College：Pharmacovigilance

Pharmacovigilance,A discipline that collects, monitors, researches, and evaluates information about health care providers and patients regarding to the adverse drug reactions , biological products, herbs, and traditional medicine.
- Source: Ddu
- 2,092
- August 24, 2021
US approves Pradaxa as oral blood thinning med for children

The Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Pradaxa as the first oral blood thinning medication to treat children aged three months to less than 12 years old in the US. The FDA has cleared Pradaxa (dabigatran etexilate) for use in children with venous thromboembolism, immediately after treatment with a blood thinner given by injection for at least five days. Pradaxa oral pellets have also been approved to prevent recurrent clots among children aged three months to less than 12 years old, who have complete treatment for their first venous thromboembolism. Lastly, the drug has been approved in capsule form to treat blood clots in patients eight years and older with venous thromboembolism, directly after they have been treated with a blood thinner given for at least five days, and to prevent clots in patients aged eight years and older who have completed treatment for their first venous ...
- Source: drugdu
- 172
- June 23, 2021
Pradaxa
Gilead’s Trodelvy scores accelerated approval in advanced bladder cancer

Gilead’s antibody drug conjugate (ADC) Trodelvy has received an accelerated approval from the US Food and Drug Administration (FDA) for the treatment of locally advanced or metastatic urothelial cancer (UC), the most common form of bladder cancer. The approval covers the use of Trodelvy (sacituzumab govitecan-hziy) in patients with advanced UC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. Trodelvy was approved on the basis of results from Gilead’s Phase II TROPHY study, which evaluated the drug as monotherapy or as a combination therapy in patients with metastatic UC after progression on a platinum-based chemotherapy and PD-1/L1 inhibitor. In 112 patients who were evaluable for efficacy, 27.7% of those who were treated with Trodelvy responded to treatment, with 5.4% experiencing a complete response and 22.3% experiencing a partial response. The study also found a median duration of response of 7.2 months for those treated ...
- Source: drugdu
- 179
- April 15, 2021
bladder cancer

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