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Scottish regulator approves first chronic hepatitis delta virus drug

Drug Discovery World

The Scottish Medicines Consortium (SMC) has become the first UK health authority to permit routine NHS use of Gilead Sciences’ Hepcludex (bulevirtide) for the treatment of chronic hepatitis delta virus (HDV) infection. HDV infection is rare, but the effects of chronic HDV infection are potentially extremely serious.

Virus 130
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FDA clears genetically engineered TIL therapy for solid tumour trials

Drug Discovery World

Technology platforms supporting Grit’s TIL and other cell therapy development include StemTexp (proprietary stemness TIL expansion platform), StaViral (stable virus transduction system), KOReTIL (efficient CRISPR KO system) and ImmuT Finder (genome-wide CRISPR/Cas screening platform).

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Successful clinical trial for re-engineered Covid vaccine 

Drug Discovery World

The University of Queensland’s re-engineered clamp platform has produced a vaccine that is equally safe and virus-neutralising as an approved Covid vaccine considered among the best in its class. He said: “CEPI is striving towards vaccines being developed within 100 days of a new virus emerging: a goal known as the 100 Days Mission.

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UK regulator approves first generic raltegravir drugs for HIV

Drug Discovery World

HIV produces an enzyme called HIV integrase which enables multiplication of the virus in cells within the body. Appropriate data have been provided to assure us that these medicines are the same as, and considered interchangeable with an already licensed reference medicine, called Isentress.

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Preclinical data supports arenaviral therapeutic vaccine for hepatitis B

Drug Discovery World

HB-400, a novel arenaviral therapeutic vaccine developed by HOOKIPA Pharma and Gilead Sciences, has been shown to generate robust T cell responses specific to hepatitis B virus with high antibody levels in a preclinical setting. A Phase I clinical trial to evaluate the safety and tolerability of HB‑400 in humans is ongoing.

Vaccine 130
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GSK’s respiratory syncytial virus

The Pharma Data

The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. The most frequently observed solicited adverse events were injection site pain, fatigue, myalgia, and headache. These were typically mild to moderate and transient.

Virus 40
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US and UK fast track designations for Parkinson’s gene therapy

Drug Discovery World

AB-1005 is an investigational adeno-associated virus 2 glial cell line-derived neurotrophic factor (AAV2-GDNF) neurorestorative gene therapy. The UK MHRA Innovation Passport is the entry point to the Innovative Licensing and Access Pathway (ILAP), which aims to accelerate time to market, facilitating patient access.

Therapies 148