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Understanding Recent Changes to 505(b)(2) Drugs and Reimbursement

Pharmacy Times

In 2022, CMS reevaluated 505(b)(2) drugs in relation to section 1847A of the Social Security Act (SSA). In 2022, based upon a complaint filed by a pharmaceutical company, CMS was asked to reevaluate the SSA section that establishes the J-code,” Soefje said. “In This went into effect in January 2022.”

FDA
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2nd Hit ID Summit

pharmaphorum

Skip to main content Friday 18 July 2025 BlueSky linkedin youtube rss User account menu Subscribe Channels Channels Digital Market Access Oncology Patients R&D Sales & Marketing Spotlight on Content type Content type Digital -News -Views & Analysis -Deep Dive -Webinars -Podcasts -Video -White Papers -Event Market Access -News -Views & (..)

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Low-Priced Oncology Disruptors: The Cuckoo in the PD-1/PD-L1 Nest or the Runt of the Clutch?

pharmaphorum

The Life Sciences Practice works with leading biotech, medical device, and pharmaceutical companies; law firms; regulatory agencies; and national and international industry associations. online] Available at: <[link] [Accessed 13 April 2022]. online] Available at: <[link] [Accessed 13 April 2022]. References.

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2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients

ISPE

2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. Tue, 11/01/2022 - 06:49. 2022 ISPE Annual Meeting & Expo Opening Keynotes Focus on Quality, Transformation, and Patients. 1 November 2022. 2022 ISPE Annual Meeting & Expo. Trudy Patterson. iSpeak Blog. Susan Sandler.

FDA
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NK cell immunotherapy: what’s next in clinical development?

European Pharmaceutical Review

Pharmaceutical companies such as Sanofi and AstraZeneca are currently conducting several high-potential clinical development programmes in oncology in collaboration with Innate Pharma. Detailed results from COAST were published in the Journal of Clinical Oncology in 2022.

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EU approves AZ’s Imfinzi plus chemo for advanced biliary tract cancer

pharmaphorum

AstraZeneca’s (AZ) Imfinzi (durvalumab) has been approved in the European Union (EU) as first-line treatment of adult patients with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin). with chemotherapy. Updated median overall survival (OS) was 12.9 months versus 11.3

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The GoCART Coalition: Guidance for pharmacists

Hospital Pharmacy Europe

GoCART aims to promote patient access to novel cellular therapies, bringing together different stakeholders, including healthcare professionals, health authorities, pharmaceutical companies, patient representatives, health technology assessment bodies, reimbursement agencies and medical non-profit organisations. GoCART Coalition.