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Q BioMed’s Uttroside-B Receives U.S. FDA Orphan Drug Designation in the Treatment of Liver Cancer

The Pharma Data

Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to Uttroside-B , a small molecule chemotherapeutic for the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer. billion by 2027. (OTCQB: QBIO), announced today that the U.S.

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AI-Designed Drugs vs. Traditional Drug Discovery: Pros and Cons

Vial

billion by 2027 , at a compound annual growth rate (CAGR) of 45.7% This acceleration of the drug discovery process could potentially save countless lives by bringing effective treatments to market more quickly. This is evident in the estimated market value for AI in drug discovery, which was US$0.6 between these years.

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How Many Clinical Trials Are Run by CROs?

Vial

The Clinical Trials Outsourcing Market – Global Outlook & Forecast 2022-2027 report lists the following key trends in the future of the CRO global market. The growth of patient populations worldwide will increase the demand for advanced treatments, driving the need for CRO services and support.

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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog: Biosimilars

This time, rather than use codes and patent certifications, the fight is over orphan drug exclusivity (“ODE”), with Jazz challenging FDA’s clinical superiority decision concerning sodium oxybate in the treatment of narcolepsy.

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FDA’s LDT Proposal and Its Impact on Clinical and Regulatory Professionals

The Premier Consulting Blog

years after publication; no earlier than October 1, 2027) End of Enforcement Discretion for: Premarket review for high-risk IVDs. Phase 3 (3 years after publication) End of Enforcement Discretion for: QS requirements (good manufacturing practice for medical devices). Phase 4 (3.5

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Analysis Life Sciences Thank You Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform

Agency IQ

Sponsors claimed that if TGA’s process was closer aligned to those of the FDA and EMA, they would submit applications for rare disease products much sooner, reducing current disparities in treatment availability for patients in Australia compared to those jurisdictions.

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Breakthrough drug candidates and cancer treatment innovations

Drug Target Review

It also supports the argument for developing ZW171 for the treatment of other MLSN-expressing solid tumours. What is the significance of ZW191 demonstrating strong responses in FRα-low expressing PDX models for the treatment of oncology indications with lower levels of FRα?

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