!
“Resultatene og en søknad om å få innpass i markedet skal nå i nærmeste fremtid sendes videre til det kinesiske byrået for medisinske produkter (NMPA).”
Dette må da nærmest være en formalitet nå? Hvor lang tid bør man påregne for klarsignal?
Har vi noen ide om utplasering av scopes? er det nærmest som vedheng på nyere scopes at det er blått lys f.eks?
Germany & Austria: 2nd edition informs patients and professionals
Gain an Advantage – Together against Bladder Cancer! Photocure’s 2nd Bladder Cancer awareness tour goes on the road again. The 2023 Roadshow starts on September 7 and will continue for a month, with 15 stops at hospitals and clinics in Germany and Austria.
As in 2021, the aim of the impressive bus and awareness campaign is to provide in-depth information to professionals and those affected by the disease about its risk factors and warning signs ‒ of which patients are often unaware when they are first diagnosed ‒ diagnostic procedures and treatment of bladder cancer.The roadshow brings the motto “Together against Bladder Cancer” to life: questions are explicitly welcome because information and exchange can provide reassurance.
A look at the numbers and facts reveals why the information campaign is important:
More than 570 000 people are diagnosed with bladder cancer annually.1b This makes bladder cancer the eighth most common cancer worldwide.1a
See the Roadshow tour plan: Die Blasenkrebs Roadshow 2023 quer durch Deutschland und Österreich » Wir heißen Sie herzlich Willkommen
About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths in 2020.1b
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with up to 61% in year one and up to 78% over five years.2Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3
Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4
1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: https://gco.iarc.fr/today, accessed [January 2022].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html
SHANGHAI, Sept. 20, 2023 /PRNewswire/ – Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, has announced that the multinational Phase III clinical trial of APL-1702 (Cevira®), a novel, non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), has met its primary endpoint. Based on the results, APL-1702 holds the potential to become the world’s first non-vaccine product with verified clinical efficacy against cervical HSIL. The company will be in communication with regulatory authorities on new drug application and market approval in the coming months.
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Lenke til nyhet på Asieris side:
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Photocure Partner Asieris announces that the First Non-Vaccine Investigational Product for Cervical HSIL has Achieved Its Primary Endpoint
Neste utbetaling fra Asieris vil bli ifbm NDA approval. Behandlingstid for innsendt NDA er 2-10 mnd.
$ tegn ved Study endpoint achived også. Hva med den? Bør komme som milepæl på Q3 eller Q4 rapporten før NDA.
Neste etter det er NDA.
Jepp, tenkte neste utbetaling etter endpoint😊
New Health Economic analysis in France concludes there is insignificant cost difference between White Light and Blue Light Cystoscopy use when applying ccAFU guidelines
Ny børsmelding på mandagsmorgenen da sikkert, pent med Late Breaking Abstract