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AI-driven drug discovery, precision medicine, and sustainable manufacturing can redefine the pharma industry

Express Pharma

and Europe held manufacturers accountable for their environmental impact, leading to an increase in partnerships with tech companies focused on sustainable packaging and production solutions. Regulatory bodies in the U.S. Finally, reshoring and localised production emerged as key strategies for improving supply chain resilience.

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Beyond instruments: streamlining process technology implementation in biopharmaceutical manufacturing

European Pharmaceutical Review

Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Figure 1 : Process analytical technology implementation in (bio)pharmaceutical GMP manufacturing. Sustainability. 2020; 12(3), 981. Lezotre PL.

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The MEK effect on cancer — a slow and steady approach to drug resistance

PharmaVoice

The FDA approved the first MEK inhibitor, a melanoma drug from Novartis, in 2013. The broad mechanism allows them to target multiple tumor types, including those with RAS mutations, which are common in melanoma, pancreatic, colorectal and lung cancers. More MEK drugs approvals followed for Genentech, SpringWorks Therapeutics and AstraZeneca.

Immunity 130
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GE HealthCare’s PET imaging agent gains Alzheimer’s label expansion

Pharmaceutical Technology

Vizamyl was first approved in 2013 to estimate beta amyloid neuritic plaque density in adult patients with cognitive impairment. Now quantification can also play a critical role in initiating and monitoring amyloid-targeted therapy for Alzheimer’s disease and determining when it can be discontinued.”

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Salt

RX Note

In 2013, the WHO recommends that adults consume <2000 mg/day of sodium. meats, fruits and vegetables) rather than their packaged counterparts. Almost all national and international organizations recommend dietary sodium reduction as part of the nonpharmacologic therapy for hypertension. breakfast cereals, canned or frozen foods).

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PDA revises report on glass container manufacturing

European Pharmaceutical Review

The long-awaited PDA TR 43 report provides an approach to a quality decision-making process and represents best practices for the identification and classification of visual nonconformities for (empty) glass containers as pharmaceutical product packaging.

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Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

FDA Law Blog: Biosimilars

However, the vast majority of the CRLs posted in the openFDA database are already available in the action packages posted on FDA’s Drugs@FDA database and approved biologics product pages. 355(l) ) requires that action packages (which include CRLs, if issued) for approved original NDAs and BLAs (i.e.,