Pharmaceutical Technology

JUNE 15, 2023

Drug development is already a difficult endeavor, with the vast majority of R&D efforts failing to produce a market-worthy product. Even reaching the clinical trial phase offers no guarantees, as only 12% of such drugs receive U.S. While this process is essential, it’s also slow, expensive and unpredictable.

Drug Development 52

Drug Development Compounding Adverse Reactions Dosage 52

FDA Law Blog: Biosimilars

MARCH 7, 2024

As a final example, current regulations require a sponsor of an investigational medical device to report to FDA (and others) “unanticipated” adverse events, which are defined in part as “serious,” and sponsors of investigational drugs to report to FDA serious and unexpected suspected adverse reactions.

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Documentation Adverse Reactions Communication Drug Development 105

RX Note

MAY 1, 2025

For example, The patient in intensive care who develops a rash while receiving multiple medications The ambulatory with complex chronic diseases who develops a new and unexplained symptom while taking many medications. The main questions that arise in such situations include: Is the adverse event related to a drug?

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Adverse Reactions Immunization Immunity Drug Development 52

Pharmaceutical Technology

SEPTEMBER 19, 2022

Additionally, no new safety events linked to the combination treatment were reported versus nivolumab monotherapy. Fatigue, musculoskeletal pain, rash, arthralgia diarrhoea and pruritus among others were found to be the most prevalent adverse reactions in the trial. In the Opdualag arm, median PFS was 6.7

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Adverse Reactions Drug Development 52

pharmaphorum

JANUARY 26, 2022

The regulatory move applies only to trials of magrolimab given alongside Bristol-Myers Squibb’s Vidaza (azacitidine), and stems from an “imbalance” in investigator-reported serious adverse events between study arms, said the drugmaker.

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Adverse Reactions Chemotherapy Immunization Immunity 40

European Pharmaceutical Review

JULY 20, 2022

Withdrawing drugs over safety concerns requires careful analysis of the health benefits and risks by regulators. 1 But while data on adverse reactions is rightly used to help with these decisions, there is currently no additional modelling on the positive impact regulatory action could have on public health. Study focus.

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Adverse Reactions Diabetes Hospitals Vaccines 97