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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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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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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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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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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

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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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Indivior must go to court over addiction drug monopoly claim

pharmaphorum

.” Indivior paid $600 million to settle criminal fraud charges of improper marketing of Suboxone in 2020, and last year agreed another payment of $300 million to resolve civil claims brought by US states.