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FDA Calls for New Safety Warning for the Class of CAR T Cancer Therapies

MedCity News

Two months after announcing an inquiry into reports of new cancers in patients treated with CAR T-cell therapies, the FDA is directing makers of these therapies to add new safety warnings to product labels describing this risk. Companies have 30 calendar days to comply.

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Patient Death Prompts FDA Hold on Tests of Drug in Atopic Dermatitis & Asthma

MedCity News

The FDA clinical hold follows a patient death from liver failure that may be associated with zelnecirnon, an experimental Rapt Therapeutics drug. The biotech notes that no other patient has experienced liver problems and this safety signal has not been seen in any other tests of the molecule.

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6 research and development life sciences predictions for 2023

pharmaphorum

From enabling patient choice during clinical trials to strengthening vital partnerships across the quality ecosystem, connected data will become the lifeblood that enables life sciences teams to collaborate efficiently and effectively in 2023. Patient choice will push sponsors toward operational excellence.

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Generative AI’s potential to speed delivery of improved patient outcomes

Clarivate

We’re mindful of some challenges that life science and healthcare organizations must work through before this technology is mature enough for use in critical business decisions that may impact patient health. Our customers entrust our products and services to help them improve patient health, and we will not jeopardize that mission.

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A sad day for us all as the FDA continues to lose credibility

World of DTC Marketing

The Financial Times said , “Michael Carome, director of the health research group at Public Citizen, said, “these costs to patients, to their families, are just not justified based upon what we know about this drug”. There are no efficacy data to clearly demonstrate this drug helps patients. Nowhere to be seen.

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How Risk-Based Quality Management Improves Data Quality, Patient Safety, Accelerating Drug Development

MedCity News

Risk-based quality management, or RBQM, is the process by which pharmaceutical organizations monitor and manage quality throughout clinical trials.

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MHRA approves first gene therapy for infusion into the brain

European Pharmaceutical Review

The product, produced by biopharma company PTC Therapeutics, is approved for patients 18 months and over. Upstaza is administered through a minimally invasive neurosurgical stereotactic procedure used to treat several neurological disorders in paediatric and adult patients. Upstaza clinical trials.