Remove 2018 Remove Biosimilars Remove Disease Remove Trials
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European Commission vs Big Pharma, or profit vs access?  

Drug Discovery World

UMNs have been defined in the context of the draft as diseases where there’s a lack of good treatments, and which have a high burden 3. For rare disease drugs, a variable RDP period of five, nine, or ten years, depending on the novelty of the drug.

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Trends in Pharmaceutical Mergers and Acquisitions

DrugBank

Gilead's assessment of the IP portfolio would have involved a detailed analysis of the patent claims, the remaining patent life, the potential for generic or biosimilar competition, and the expected revenue streams from Trodelvy in various markets. However, such acquisitions also entail significant risks for biotech firms.

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A review of Japan’s drug discovery and development landscape  

Drug Discovery World

Similarly, biosimilars are expected to grow. In 2018, for instance, Tohoku University signed a partnership agreement with Phillips Japan, a subsidiary of Dutch multinational Phillips, to conduct joint research in the field of healthcare. Indeed, Phillips has a co-creation space at Tohoku University’s CRIETO hub. .

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Innovation Drives Excellence, Innovent Successfully Held 2020 Virtual R&D Day

The Pharma Data

that are fast progressing clinical trials. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of cancer, metabolic, autoimmune and other major diseases. TYVYT® is the only PD-1 inhibitor included in the NRDL.

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CHOICE-01 Phase III Study of Toripalimab at the Interim Analysis Met Pre-Specified Primary Endpoint of Progression-Free Survival at the First-Line Treatment of Advanced NSCLC

The Pharma Data

The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety.

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FDA Grants Toripalimab Fast Track Designation for Mucosal Melanoma

The Pharma Data

Meanwhile, the FDA has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial). and a disease control rate (DCR) of 86.2%

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Analysis Life Sciences Thank You Keeping track of FDA’s user fee program performance

Agency IQ

BY ALEXANDER GAFFNEY, MS, RAC JUL 10, 2023 10:02 AM CDT As of FY2023, the FDA has five user fee programs applicable to its life sciences portfolio: PDUFA (for non-generic prescription drugs and certain biologics), MDUFA (for medical devices), GDUFA (for generics), BsUFA (for biosimilars), and OMUFA (for over-the-counter monograph products).

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