Remove 2024 Remove FDA Remove Pharma Remove Prospecting
article thumbnail

Microbiome therapies: a maturing movement

European Pharmaceutical Review

Notably, gut microbiome was found to linked to cancer CAR T therapy response, based data from the largest prospective study of its kind, published in Nature Medicine in March 2023. Of note, the US Food and Drug Administration (FDA) and ANSM (French regulatory authorities) have established themselves as early leaders to develop guidelines.

article thumbnail

From viral vectors to nucleic acids: biopharma’s evolving manufacturing landscape

European Pharmaceutical Review

Vikas Gupta (VG): In the years preceding the Covid pandemic, the ATMP s market, including both the innovators as well as the contract development and manufacturing organisations (CDMOs), was a bit too optimistic about its growth prospects as it was building significant manufacturing capacity focusing primarily on viral vectors.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Building Your Brand In Medical Device Sales With Pat Kothe

Evolve Your Success

He reflects on his early career in pharma and B2B sales, and how it led him to his entrepreneurship journey. He had a small stint in pharma at the very beginning of his career and even had a stint in B2B sales right out of college. We have launched into the US marketplace and got the product design through FDA.

Sales 52
article thumbnail

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In January, amidst calls to improve patient safety by optimizing licensed drug formulations, the FDA released a draft guidance that signalled a departure from the most commonly used method of identifying a new therapy’s ideal dosage.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

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.

article thumbnail

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. .

Marketing 104