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Advancing AOCs to transform the delivery of RNA therapeutics

European Pharmaceutical Review

mAbs have well-established safety profiles, high specificity and affinity and long half-lives – they have been used in drug development for more than 30 years. Known linkers in the RNA field are used to bond together the two pharmacologically active molecular entities and can be applied to multiple oligonucleotide modalities.

Safety 98
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FDA suggests ways to curb constraints with rare disease gene therapy trials

Pharmaceutical Technology

Still, Blank suggested that companies enroll the patient population that is most likely to benefit, because early phase studies contain the most safety risks. Blank acknowledged that in many cases, an exclusively paediatric patient population could lead to difficulties with drawing consent for early phase trials.

FDA 105
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Pharmacodynamics and Pharmacokinetics: The Science Behind Drug Action (Understanding the different characteristics of a drug and how they are important for therapeutic success)

Pharmaceutical Representative Training

3 Together, these processes determine the drugs concentration in the bloodstream and tissues over time, directly impacting its effectiveness and safety. A highly effective drug (PD) may pose safety concerns if it accumulates due to slow metabolism or excretion (PK). Rang & Dale’s Pharmacology. Accessed January 3, 2025.

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Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

Legacy MEDSearch

The primary safety endpoint is a performance goal for device and procedure related adverse events at 30 days. The FDA-approved randomized IDE trial has been designed to validate the safety and effectiveness of PiCSO.” The PiCSO Impulse System received ‘Breakthrough Designation’ from the FDA in 2019 and the CE-Mark in 2020.

Medical 52
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Digital Self-Neuromodulation Therapy for PTSD: Interview with Oded Kraft, CEO of GrayMatters Health

Medgadget

While for other patients the possible adverse side effects from medication may prevent them from finding pharmacological therapies effective. Throughout 2016 and until mid-2019 we conducted a deep technology due diligence, as well as market research, and met and spoke with dozens of mental healthcare providers.

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Embracing green innovation in life sciences

European Pharmaceutical Review

At Chiesi, we are conducting the same rigour in terms of safety and bioavailability studies as we would for a new molecule, navigating regulatory and reimbursement discussions, and having to build entirely new manufacturing sites and capabilities. Pulmonary Pharmacology & Therapeutics. 2024; 85: 1-9. Internet] The Aerosol Society.

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MHRA Chief Executive to step down

European Pharmaceutical Review

While she is stepping down from her current role, Dame June shared that she still hopes to contribute] “to patient safety and public health in other ways” “It has been an enormous privilege to have led the MHRA through a time of change which is unprecedented in UK medical products regulation.

Safety 111