Alta Sciences

APRIL 17, 2024

Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues. Asia, and Europe.

Drug Development 52

Drug Development Treatment FDA Approval Drugs 52

Drug Target Review

SEPTEMBER 10, 2024

Drug developer companies across the pharma industry report notable reductions in drug development timelines where 10 to 12 months, from lead monoclonal antibody (mAb) identification to IND application, is the new norm and in which earlier Tox material generation has been a critical component for shortening IND timelines.

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Drug Development Clinical Supply Production FDA 64

Conversations in Drug Development Trends

MAY 30, 2024

Differences in regulatory sentiments and industry sponsors’ subsequent clinical development strategies historically restricted access based on geography.

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Treatment Clinical Trials Small Molecule Therapies 81

FDA Law Blog: Drug Discovery

DECEMBER 6, 2024

Valentine On November 19, 2024, FDA released a draft guidance titled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products. Where vector presence is detected, transgene mRNA and/or protein expression levels should also be measured. Tobolowsky & Charles G. Raver & James E.

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Therapies FDA Production Disease 59