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In Conversation: Dr. Shane Hegarty from Axonis Therapeutics

Zymewire

Over t his period , Axonis has brought together and become world leaders in KCC2 biology , which has further separated us from our competition. To what extent has the prospect of a looming recession influenced your research & development strategy? It was a “Technology in Space” grant put together by the ISS NL , NASA, and Boeing.

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Building Your Brand In Medical Device Sales With Pat Kothe

Evolve Your Success

We have launched into the US marketplace and got the product design through FDA. My company standpoint is, “Online is the new prospecting tool.” Online is the new prospecting tool. I’ve got an FDA issue.” It’s very competitive. We are launching it here in the US. I embrace it too.

Sales 52
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FDA gives Ferring go-ahead for Adstiladrin gene therapy manufacturing

Pharmaceutical Technology

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). The company aims to then increase supplies in 2024.

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FDA drug dosage optimisation guidelines signal clinical trial reform

Pharmaceutical Technology

In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.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.

FDA 115
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Exforge antitrust settlement caps Novartis’ year of legal disputes

Pharmaceutical Technology

The alleged actions violated the Hatch-Waxman Act, formally known as the “Drug Price Competition and Patent Term Restoration Act of 1984,” which allows generic manufacturers to market their generic versions of previously approved generic medications. These actions allegedly led to the extension of Novartis’ patents.

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Humira biosimilars set the stage for long-awaited 2023 US launches

Pharmaceutical Technology

There are seven FDA-approved Humira biosimilars, of which Amgen’s Amjevita will be launched in January. Others are made by big pharma giants like Boehringer Ingelheim , Novartis , or Pfizer , which has raised the expectations for a competitive market. . Biosimilar uptake could be more gradual.

Marketing 104
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Covid-19 vaccine success bolsters nanoparticle drug delivery research

Pharmaceutical Technology

Covid-19 vaccines from Moderna and Pfizer /BioNTech, which use lipid nanoparticles, became the only two FDA-approved vaccines for almost all ages. However, after a period of slow movement in the field, the FDA approved the first nanodrug, Doxil, for Kaposi sarcoma in 1995. GlobalData is the parent company of Pharmaceutical Technology.