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

Pharmacy Times

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. So, the pharmaceutical companies then pushed to get their 505(b)(2) drugs declared sole source,” Soefje said. “If This went into effect in January 2022.”

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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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Chemo-free regimen demonstrates efficacy in NSCLC

European Pharmaceutical Review

Janssen Pharmaceutical Companies of Johnson & Johnson’s Phase III MARIPOSA study is the first to show a clinically meaningful benefit in a chemotherapy-free regimen compared to the small molecule treatment TAGRISSO ® ( osimertinib ).

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Country focus: China & APAC’s growing medical needs bring opportunities and challenges

pharmaphorum

At the same time, lots of people with experience at multinational pharmaceutical companies have chosen to return home. All these factors will support the growth of in-house R&D-driven pharmaceutical companies and bring more innovative drugs to Asian markets.”. Chemotherapy still accounted for 72.6%

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GlobalData forecasts ADC NSCLC market to reach $3.9 bn in 2032

Express Pharma

Datroway is currently being evaluated in five Phase III clinical trials as a first-line therapy in combination with immune checkpoint inhibitors (ICIs), bispecific antibodies, and epidermal growth factor receptor inhibitors. AbbVie, AstraZeneca, and Daiichi Sankyo. 7MM: The US, France, Germany, Italy, Spain, the UK, and Japan.

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In the precision medicine era, the line between products and services is blurred

pharmaphorum

Traditionally, cancer patients are treated using “one size fits all” interventions like chemotherapy, radiotherapy and surgery. To deliver these unique therapies to patients, pharmaceutical companies must partner with a wide range of specialized third parties including laboratories, manufacturers, shipping and storing providers.

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

European Pharmaceutical Review

He discusses why NK cell therapy’s ability to generate ‘synthetic immunity’ in the body means this modality holds potential as an anti-cancer treatment. We specialise in the development of new cutting-edge immunotherapies , based on the use of therapeutic antibodies capable of activating the immune system to fight cancer.