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FDA Releases Draft Guidance on Essential Drug Delivery Outputs

FDA Law Blog

FDA recently released a much-anticipated draft guidance to address these frequent questions: Essential Drug Delivery Outputs for Devices Intended to Deliver Drugs and Biological Products. Drug delivery includes successful product preparation and the initiation, progression, and completion of dose delivery.

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Intranasal Therapeutics and Drug Delivery Systems: The Perfect Alternative to Conventional Route of Administration

Roots Analysis

Interestingly, over the past few years, drug developers focused on non-respiratory diseases have also shifted their attention towards intranasal drug formulations. This can be attributed to ease of delivery, increased bioavailability and by-pass of first-pass metabolism offered by this type of route of administration.

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Scilex buys rights to acute migraine treatment Elyxyb in Canada and the US

Pharmaceutical Technology

Elyxyb is a prescription nonsteroidal anti-inflammatory drug (NSAID) used for acute migraine treatment in adult patients with or without aura. It is formulated using a self-micro-emulsifying drug delivery system that improves the drug’s bioavailability and solubility.

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Pharmanovia taps Nanoform to improve bioavailability of ‘iconic branded medicine’

Outsourcing Pharma

The pharmaceutical company has forged a partnership with the nanotechnology specialist to use nanoparticle tech and formulation to advance its products.

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Vevye: A New Cyclosporine Solution for Dry Eye Disease

XTalks

Furthermore, the bioavailability of the active pharmaceutical ingredient (API) into the cornea is up to four times stronger with EyeSol technology. Attendees will understand best practices for novel drug delivery design and development. What Is Dry Eye Disease?

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Oral Protein / Peptide-based Drugs: Addressing Key Unmet Needs Across Disease Indications

Roots Analysis

However, it is important to highlight that there are still several challenges which need to be addressed in order to develop biologic drugs capable of effectively being administered via the oral route without undergoing significant losses in specificity and / or bioavailability. Oral Protein / Peptide-based Drugs. Web: [link].

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Considerations for Neuroscience Trials with Intrathecal Delivery and Other Methods of Direct CNS Administration

XTalks

One of the biggest challenges with developing therapies to treat CNS disorders is the delivery of systemically administered investigational products (IPs) to the brain, which is limited by the blood-brain barrier. Some methods of direct CNS administration include intrathecal, intraparenchymal and intracerebroventricular (ICV) delivery.

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