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  1. FDA issues first cGMP warning letter citing AI misuse in pharmaceutical manufacturing A Michigan-based lab has become the subject of the FDA's first dedicated enforcement action on artificial intelligence misuse in drug manufacturing — a landmark event with...
  2. Epitopea receives MHRA approval for first-in-human trial of RNA vaccine for ovarian cancer The company has received regulatory approval from the MHRA and Regional Ethics Committee to initiate its OVACT Phase I/Ib clinical trial of CryptiVax-1001, an off-the-shelf...
  3. Japanese pharma companies shifting to earlier CDMO outsourcing as peptide complexity increases Neuland Laboratories has reported a notable shift in Japanese pharmaceutical outsourcing patterns during the past 12-24 months, with companies engaging CDMOs earlier in the...
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    Britain's biotech potential (part I): world-class science, second-class support? The UK produces top-tier life sciences research, offers favourable conditions for early-stage investment and hosts a growing network of internationally competitive clusters. So...
  5. UK REACH reform falls short as industry warns of £500m+ compliance bill The UK chemicals industry has condemned the Government's long-awaited response to the UK REACH Alternative Transitional Registration model consultation, arguing it does little...

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Related Content

Cell & Gene Therapy

CPTx appoints David Maier as President of ssDNA CDMO Unit: gxstrands

Mr Maier comes to gxstrands with more than 20 years of biopharmaceutical executive and commercial experience
Finance

CPTx and NanoCell awarded EU funding for in vivo CAR T therapy with immune-silent single-stranded DNA

The QUIET-CAR project that targets cancer and autoimmune diseases is top-ranked among the 120-plus Eurostars Grant submissions
Research & Development

Opening new doors to precision medicine with single-stranded DNA (ssDNA): part II

In the second part of this article, the benefits of ssDNA in terms of efficient cellular uptake and stability, the application of self-folding nanocarriers for gene delivery and mechanisms of action are discussed, along with a forward-thinking review of future perspectives and challenges
Research & Development

Opening new doors to precision medicine with single-stranded DNA (ssDNA): part I

In this two-part article, the science behind ssDNA manufacturing is explored, along with the innovations that are enhancing the therapeutic benefits of ssDNA-derived constructs. A comparative analysis of traditional double-stranded DNA (dsDNA) and other nucleic acid-based methods is also included
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