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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Observational studies should not be seen as competition to RCTs but as complementary to them, and as a sector we need to stop working in silos and develop an integrated and more comprehensive approach to evidence-based decision-making in safeguarding public health. 2018; 8(1). EMA/95098/2010.

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Sanofi trumpets data with haemophilia treatment duo at ISTH

pharmaphorum

The company had been eyeing a possible regulatory filing for fitusiran this year, but has now set back the timeline – possibly until 2024 – while it gathers data on the revised dosing schedule, in the hope of maintaining efficacy with fewer clotting side effects. Sanofi acquired the drug when it bought Bioverativ in 2018 for $11.6

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Pharma’s temporary reputation bump

World of DTC Marketing

How long do you believe it will be before the media once again runs stories about drug prices or drug side effects? They have “paid to delay” competition for their top drug while taking a slew of price increases. We just the CEOs of Lilly and GSK get huge compensation packages when, again, pharma raised prices.

Pharma 164
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Can the FDA keep the momentum going for rare disease drug approvals?

Pharmaceutical Technology

In 2022, the FDA approved only 37 new medicines, an underwhelming number compared to 98 in 2018. However, while only around 34% of the approvals in 2018 were for orphan drugs, 54% new approvals in 2022 were for drugs to treat rare diseases. rises/second (SD 0.0628) in the placebo group.

FDA 126
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FDA proposes new model for easy-to-understand prescription guides

Pharmaceutical Technology

The document would include the drug/biological product name, side effects, directions for use, safety information, and a concise summary of indications and uses. According to a 2018 study , nonadherence is especially an issue in the case of chronic illness where patients may be expected to take medications at least once daily.

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The “Medical Bypass”: new drugs to strike obesity

Pharmaceutical Technology

A 2017–2018 National Health and Nutrition Examination Survey (NHANES), showed that 30.7% In the past, obesity medications were often dismissed due to insufficient efficacy data and the fact that they were associated with a high occurrence of side effects. The same can be said for the US. of adults were overweight, 42.4%

Medical 105
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Pharma Fix: The quest for the next tuberculosis vaccine

Pharmaceutical Technology

Fox says adjuvant protein subunit vaccines can be a safer approach compared to live attenuated virus vaccines as there is a minimized risk of developing side effects. Results from the Phase II trial were released for the vaccine in September 2018.

Pharma 64