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Clinical trials authorised for 3D-printed ulcerative colitis drug

European Pharmaceutical Review

a China-based pharma company has announced it has received clearance for its Investigational New Drug (IND) application from the US Food and Drug Administration (FDA) to initiate clinical studies of T21, a 3D-printed medicine that can target specific segments in the colon to more safely deliver oral ulcerative colitis (UC) drugs.

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Merck gives taxpayers the middle finger

World of DTC Marketing

to produce, according to a report issued last week by drug pricing experts at the Harvard School of Public Health and King’s College Hospital in London. Remdesivir was the first drug approved by the Food and Drug Administration to treat COVID-19. And while it costs $17.74 Merck charges the U.S.

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Novel haemophilia B gene therapy approved

European Pharmaceutical Review

The US Food and Drug Administration (FDA) has approved the adeno-associated virus (AAV)-based gene therapy BEQVEZ (fidanacogene elaparvovec-dzkt) for certain adults with haemophilia B. This authorisation of BEQVEZ is based on results from the pivotal Phase III BENEGENE-2 study.

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Citrate-free HCF of adalimumab biosimilar gets positive opinion

European Pharmaceutical Review

Upon approval, the adalimumab citrate-free high concentration (100mg/ml) formulation will have the same auto-injector, the currently offered drug delivery option. According to the EMA, TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Hyrimoz is used to treat.

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Novel oral chemotherapeutic holds potential for stomach cancer patients

European Pharmaceutical Review

Several lifestyle factors have been shown to increase the risk of developing stomach cancer, including alcohol consumption, smoking and consuming foods preserved by salts. There is an urgent need for more effective chemotherapy treatments with less severe toxicity and side effects.

Patients 104
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EMA validates first regulatory submission for CRISPR-based medicine

European Pharmaceutical Review

The edited cells, exa-cel, are then infused back into the patient as part of an autologous hematopoietic stem cell transplant (HSCT). The elevation of HbF by exa-cel has the potential to reduce or eliminate painful and debilitating vaso-occlusive crises for patients with SCD and alleviate transfusion requirements for patients with TDT.

Medicine 111
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ESG Top Trends: Technology trends

Pharmaceutical Technology

AI also speeds up the drug development process, which could translate into cheaper drugs for patients. Additionally, AI can improve patient wellbeing by automating health records, predicting illness, and enhancing treatment efficiency. 3D bioprinting offers an alternative to animal testing in drug development.