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DEA Reaffirms Synthetic THC Compounds Are Schedule I Controlled Substances

The FDA Law Blog

THC acetate esters are different than delta-9-THC, the psychoactive compound found naturally in the cannabis plant. Dr. Boos explained that delta-9-THCO and delta-8-THCO have similar chemical structures and pharmacological activities as compounds in the cannabis plant so they fall within the definition of THC. Terrence L. Boos, Ph.D.,

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AbbVie, Anima Biotech announce collaboration worth $580M plus

pharmaphorum

Anima uses its mRNA Lightning platform to discover small molecules and determine their mechanisms of action for diseases previously deemed undruggable, with scientists searching for compounds that target proteins with roles in regulating mRNA, so as to affect disease states through post-transcriptional regulation (i.e.

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3D printing and personalised medicines: embracing innovative technologies

Hospital Pharmacy Europe

Supporting the successful compounding of drugs with 3D printing processes has the potential to not only fulfil unmet patient needs but also drive efficiencies in hospital pharmacies. 2 The first drug produced through printing technology based on inkjet on powder was approved by the US FDA in 2015.

Hospitals 111
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HPLC-MS/MS for NDMA impurity determination in sartans

European Pharmaceutical Review

In 2018, one batch of the generic drug valsartan was recalled due to unacceptable levels of the nitrosamine impurity NDMA. Nitrosamine impurities are undesirable organic compounds with genotoxic, carcinogenic and mutagenic activity. This was the first of numerous recalls due to N -nitrosamine impurities in these types of drug.

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Targeting tumours with novel radiopharmaceuticals

European Pharmaceutical Review

The development of novel radiotherapeutics ushered in a new era in targeted treatment 1 for cancer, with two separate radiotherapeutic approvals in Europe and the US, in 2018 and 2022. With alpha particles, you must be very careful how the drug is made to ensure that the compound remains stable between manufacturing and use.

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2020 review – Pharma’s progress outside of COVID-19

pharmaphorum

The FDA has gone on to grant a fast review of the results ahead of a regulatory decision on the new lung cancer indication next year. There was some steady progress in neurology – in February FDA approved Lundbeck’s eptinezumab prophylactic treatment for migraine, the last from a gang of four drugs from a new class.

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ViiV claims $1.25bn settlement from Gilead in HIV patent dispute

pharmaphorum

The litigation extends back to 2018, when ViiV – a joint venture majority owned by GlaxoSmithKline alongside Pfizer and Shionogi – accused Gilead of infringing its patents on HIV integrase inhibitor dolutegravir. A patent dispute between ViiV Healthcare and Gilead Sciences has been resolved, with Gilead agreeing to pay a $1.25