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Are timely access and robust safety mutually exclusive?

pharmaphorum

And how can regulators balance timely access with robust safety? A European Federation of Pharmaceutical Industries and Associations (EFPIA) report published earlier this year, for example, compared the timelines of six regulatory agencies between 2011 and 2020. The post Are timely access and robust safety mutually exclusive?

Safety 98
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Thursday pharma headlines

World of DTC Marketing

regulators knew about reports of suicidal behavior in men taking the anti-baldness treatment Propecia when they decided not to warn consumers of those potential risks in a 2011 update of the popular drug’s label. The national vaccine safety surveillance program run by the Centers for Disease Control and Prevention (CDC) and the U.S.

Pharma 180
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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4

Medicine 116
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FDA extends review of GSK’s myelofibrosis drug

Pharmaceutical Technology

The trial’s data readout found that the momelotinib group had a favourable safety profile and the drug caused clinically significant improvements in myelofibrosis-associated symptoms, anaemia symptoms, and more, in comparison to the danazol group.

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Innovating allergy drug delivery with a needle-free alternative

European Pharmaceutical Review

World Allergy Organization (WAO) White Book on Allergy 2011-2012: Executive Summary. neffy, Epinephrine Nasal Spray, Demonstrates a Positive Efficacy and Safety Profile for the Treatment of Allergic Reactions in Pediatric Patients at Risk of Anaphylaxis: Phase 3 Study Results. Hand (N Y). 2007; 2(1):5-11.

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Early cell therapy successes start to turn the tide in lupus

Pharmaceutical Technology

In August 2021, Saphnelo, a type 1 interferon receptor antibody, became the first lupus treatment to be approved since GSK’s Benlyta (belimumab) won a regulatory nod in 2011. The CAR-T therapies for conditions like lupus continue to look promising, but their safety is a concern, says Gilkeson. MSCs and CAR-Ts for lupus.

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Botanical drugs – what is the best way forward for regulatory and market approval?

European Pharmaceutical Review

The FDA’s role in the regulation of botanical drug products includes an assessment of their safety and efficiency 5 but insufficient evidence for efficacy is one of the most common reasons why new drug candidates fail to reach this step. 6 Thus, it is critical to ensure the consistency of therapeutic effect across batches (see box).

Marketing 103