Pharmaceutical Technology

FEBRUARY 17, 2023

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage. The focus on identifying the ideal drug dosage is not new.

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Pharmaceutical Technology

MARCH 6, 2023

Currently, most drugs being investigated for their healthy aging or anti-aging properties are being repurposed from readily accessible FDA-approved drugs. Barzilai hopes that the well-established profile of the drug may allow the FDA to accept the trial more easily and then other aging-related studies can follow.

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ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. He presented on “Quality: A Key Ingredient for Stable Pharmaceutical Supply Chains.”. Director, Office of Pharmaceutical Quality. Tue, 11/01/2022 - 06:49.

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pharmaphorum

JUNE 29, 2022

Non-COVID prescription medicines didn’t stop launching during the pandemic — approvals by both the FDA and the EMA were, in fact historically high in both 2020 and 2021. She has an extremely wide experience of international pharmaceutical industry issues, consulting to the world’s leading pharmaceutical companies on global issues.

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Pharmaceutical Technology

FEBRUARY 1, 2023

RSV researchers at major pharmaceutical companies are currently working to develop new RSV drugs to beat future waves of RSV infection and gain the first RSV vaccine FDA approval. Pharmaceutical companies are pushing to develop drugs and vaccines for RSV with these populations in mind.

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Pharmaceutical Technology

MARCH 22, 2023

In the 1990s, generic pharmaceutical companies in the European Union (EU) offshored the manufacturing of active pharmaceutical ingredients (API) primarily to China. It was a money-saving strategy that was paying off until Covid-19 hit.

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Pharmaceutical Technology

FEBRUARY 6, 2023

The FDA approved both drugs in 2014. In an email , a Pliant spokesperson told Pharmaceutical Technology , “As currently approved therapies are not well tolerated, a new agent with a favorable safety profile and demonstrated efficacy would be a welcome addition to the IPF treatment armamentarium”.

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