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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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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. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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

The Premier Consulting Blog

The FDA is proposing a change to its regulations to explicitly classify In Vitro Diagnostics (IVDs) as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), irrespective of the manufacturer being a laboratory that previously conducted business and was certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

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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

Roche post-approval change submission to be first test of Accumulus Synergy’s cloud platform Although individual regulators are increasingly adopting online, cloud-based approaches to interface with sponsors, there’s been no centralized cloud platform to support efficient submissions to multiple regulators.

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Article EMA Thank You What we expect European regulators to do in August and September 2024

Agency IQ

What we expect European regulators to do in August and September 2024 In this recurring feature, AgencyIQ, through public data and previous analysis, determines what European medicine and device regulators will likely do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods, and more.

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BioMarin Boosts Enzyme Therapy Business with Inozyme Acquisition

The Pharma Data

This significant move underscores BioMarin’s ongoing expansion and strengthening of its portfolio in enzyme therapy a key area for the treatment of rare and serious disorders with high unmet medical need. This is where INZ-701 comes in.

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Article Periodic Thank You Why comprehensive state-level bans on PFAS in products are faltering

Agency IQ

Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. In addition, the law prohibits the sale of carpets or fabric treatments containing PFAS as of January 1, 2023.