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First patient receives new engineered mRNA epigenetic

European Pharmaceutical Review

revealed the first patient to be dosed with OTX-2002, the first programmable mRNA therapeutic for c-Myc (MYC) oncogene overexpression, which targets cancer cells while sparing healthy cells. OTX-2002 is delivered via lipid nanoparticles (LNPs) and controls the expression of specific genes using epigenetics, a new era of medicine. .

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Key developments: mRNA vaccines and therapeutics

European Pharmaceutical Review

Robust analytical methods are needed to establish safety, potency, and purity of mRNA therapeutics in large-scale manufacturing. Sarah Bundra, Pharmaceutical Analyst at GlobalData also warned about patient safety: “introducing mRNA carries the risk of activating the immune system.”

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EU proposes new blood, tissues and cells Regulation

European Pharmaceutical Review

The European Commission (EC) has issued a draft proposal for a new EU Regulation on blood, tissues and cells (BTC) to help increase the safety and quality of substances of human origin (SoHO). The EC noted that the EDQM’s standards “will now become the primary means to meet the EU standards of quality and safety for BTC.”.

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Personalizing the Cancer Patient Journey

Pharma Marketing Network

The IMPORTANCE of PHARMACOVIGILANCE Safety Monitoring of Medicinal Products. Reach out at swhite@xaviercreative.com. Connect at linkedin.com/in/sunnywhite/ . REFERENCES: Organization, World Health. Accessed June 18, 2022. The post Personalizing the Cancer Patient Journey appeared first on Pharma Marketing Network.

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Competition is on the horizon for costly narcolepsy treatments

pharmaphorum

Sodium oxybate — which in the late 1980s was marketed to bodybuilders and then became known as GHB and criminally used as a date rape drug — has been sold under the brand name Xyrem after gaining FDA approval in 2002. Two decades of exclusivity.

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mRNA non-vaccine therapeutics to generate $2 billion by 2028

European Pharmaceutical Review

GlobalData stated that if development is successful for Ultragenyx’s OTX-2002 , which has potential to be the first programmable epigenetic medicine, it could generate $1.6 Robust analytical methods are needed to establish safety, potency, and purity of mRNA therapeutics in large-scale manufacturing. billion during 2028.

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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Over the past few years, we have researched the types of evidence used in regulatory decisions for drug product withdrawals due to safety concerns in Europe. But from a safety point of view, observational studies can be more representative of the population the drug will serve. Meta-analyses contributed least frequently (31.4

Medicine 116