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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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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
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Hip Innovation Technology Announces Initiation of FDA Approved Investigational Device Exemption Study

Legacy MEDSearch

The IDE Study is being conducted to determine the safety and effectiveness of the HIT Reverse HRS in Primary Total Hip Arthroplasty (THA). Safety will be assessed through the collection of device-related adverse events and patient quality of life metrics. About Hip Innovation Technology, LLC.

FDA 98
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Using RWE in rare disease drug development: effective innovations with historical controls

European Pharmaceutical Review

11 have recently conducted an analysis of international HTA submissions from 2011-2019 to determine the acceptability of single arm clinical studies and ECs as part of the drug reimbursement process. 2011 May; 46(3): 399–424. Patel et al. FDA presentation. Available at: [link]. Multivariate Behav Res. doi: 1080/00273171.2011.568786.