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FDA tackles opioid crisis with OTC Narcan approval

Pharmaceutical Technology

On March 29, the US Food and Drug Administration (FDA) granted approval for the first nonprescription, “over-the-counter” (OTC) naloxone nasal spray, Narcan. The overdose death rate in the US increased more than 250% from 1999 to 2019, as per a Canada-US joint white paper on substance use and harms.

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CMO Moves: Regulatory catalysts for drug manufacturing – March 2023

Pharmaceutical Technology

Based on the individual contract, these CMOs manufacture small molecules or biological active pharmaceutical ingredients (APIs), as well as packaging material, and are charged with other related functions. Sharp Packaging Services is producing the solid dose of the drug and packaging it.

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Quality first: How pharma can meet injectables demand while staying compliant

Pharmaceutical Technology

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.

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CMO Moves: Regulatory catalysts for therapy manufacturing -January

Pharmaceutical Technology

While Catalent Inc and PCI Pharma Services are in charge of the solid dose and packaging of Lupkynis, Lonza is manufacturing the small molecule API. FDA expands approval labels. The FDA passed several positive supplementary approval decisions involving younger patients. Source: GlobalData Pharmaceutical Intelligence Center.

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‘Right shoring’ API production in Europe

Pharmaceutical Technology

The European Commission plans to launch its revised EU pharmaceutical package in Q1 2023 to ease drug shortages,” she says. Among other things, supply chain optimisation, maintaining access to affordable vaccines, and supporting innovation for unmet clinical needs will be the discussion topics, she adds.

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The Important Role that Biopharmaceutics Plays in Accelerating Early-Phase Drug Development

Pharmaceutical Technology

Fraction absorbed is directly related to the solubility, dissolution, and permeability of a compound and is the amount of drug that enters the intestinal enterocyte in our gastrointestinal tract (FDA definition), whereas bioavailability (F) is the amount of drug in the systemic circulation able to have a therapeutic effect.

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What’s next for Container Closure Integrity Testing?

Pharmaceutical Technology

A vitally important assay used across various stages of drug development and manufacturing, container closure integrity testing (CCIT) involves evaluating packaging systems to determine their ability to protect the stability and sterility of pharmaceutical products. The evolution of CCIT. Many test methods have thus been developed.