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Alzheimer’s vaccine granted Fast Track designation

European Pharmaceutical Review

AC Immune SA has received Fast Track designation from the US Food and Drug Administration (FDA) for its anti-amyloid beta (Abeta) active immunotherapy vaccine candidate for Alzheimer’s disease. The anti-Abeta therapy “specifically targets the most toxic forms of Abeta” according to Dr Andrea Pfeifer, CEO of AC Immune SA.

Vaccines 105
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FDA grants GSK first-ever approval for RSV vaccine

Pharmaceutical Technology

After a winter marked by a rise in hospitalisations due to the RSV, the FDA has granted its first approval for an Respiratory Syncytial Virus (RSV) vaccine to GSK’s Arexvy for adults ages 60 years and above. These recommendations and the FDA approval were based on positive AReSVi-006 Phase III trial data.

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Low Dose Naltrexone and Hashimoto’s

The Thyroid Pharmacist

You may be familiar with naltrexone, which is an FDA-approved medication that has been used since the 1980s for opioid withdrawal. However, low doses of this medication (hence, low dose naltrexone or LDN), have been found to modulate the immune system and have shown promise in improving cases of autoimmune disease. Doses of 1.5-4.5

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SNIPR targets antibiotic resistance with CRISPR-based gene therapy trial

Pharmaceutical Technology

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. Several CRISPR-based gene therapies are in development , with one for sickle cell disease and transfusion-dependent beta thalassemia (TDT), being examined by the FDA for an approval. Please check your email to download the Report.

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Eucure Biopharma and Chipscreen NewWay sign licence deal for YH008

Pharmaceutical Technology

It was engineered with an Fc-silent IgG1 isotype to avoid activation of Fc-receptor-mediated non-specific immune. The bispecific antibody was found to conditionally activate the immune pathway in the tumour microenvironment in vitro and in vivo trials. Please check your email to download the Whitepaper.

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Sunshine Biopharma signs licence deal for Covid-19 treatment

Pharmaceutical Technology

PLpro is the second coronavirus protease responsible for suppressing the human immune system, causing more severe Covid-19. Recently, the US Food and Drug Administration (FDA) granted emergency use authorisation (EUA) for Paxlovid, an inhibitor for the first protease of SARS-CoV-2 (Mpro).

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The future of the gene therapy market: driving innovations in biotherapeutics

Pharmaceutical Technology

The first FDA-approved gene therapies (Luxturna and Kymriah) entered the market in 2017. Today, the number of FDA and EMA-approved gene therapies is on the rise, with many more currently under development. Additional research includes identifying ways in which immune systems can be altered to better recognise cells that are a threat.

FDA 52