MHRA and NICE launch aligned pathway for faster medicine regulation
The Medicines and Healthcare products Regulatory Agency (MHRA) and the National Institute for Health and Care Excellence (NICE) will make …
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Quintessence debuts first ‘living’ artificial cell for CGT bio-separation
Quintessence Biotech has launched a bio-separation tool to reduce the manufacturing bottleneck suffered by cell and gene therapies (CGTs), creating …
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Huntington’s gene therapy research has reached a turning point, expert says
Despite unanticipated regulatory hurdles following promising clinical results with a novel investigational treatment for Huntington’s Disease, the significance of the …
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Calls for change as access to cell and gene therapies in the Netherlands falls short
The Netherlands is falling behind other European countries in providing access to advanced therapy medicinal products (ATMPs) according to Peter …
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Excalipoint debuts with $68.7m to progress TCE pipeline
Chinese biotech Excalipoint Therapeutics is looking to progress its pipeline of T-cell engager (TCE) therapies in immunology and oncology as …
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GSK prepared for potential expansion of meningitis vaccine schedule amid UK outbreak
Amid an ongoing outbreak of meningococcal disease in Kent, England, GSK has said it is ready to work with UK …
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Navigating the valley of death: a how-to from an investor’s perspective
In a crowded biotech landscape full of potential, especially in advanced therapeutic medicinal products (ATMPs), companies must differentiate themselves from …
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R1 Therapeutics raises $77.5m to progress AP306 for hyperphosphatemia
R1 Therapeutics has raised $77.5m in an oversubscribed Series A funding to advance AP306 for hyperphosphatemia in chronic kidney disease …
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FDA issues CRL to Aldeyra’s reproxalap drug application
The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) to Aldeyra Therapeutics for its new …
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Transient but transformative: Sanofi’s mRNA CAR-T enters in vivo race
In a recent article in Molecular Therapy, Sanofi presented preclinical data for an in vivo CAR-T platform that reengineers T …
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Autologous versus allogeneic: how cell therapy development is changing in oncology
Cell therapies have gained steam in oncology since Novartis’s Kymriah (tisagenlecleucel) became the first chimeric antigen receptor (CAR)-T cell therapy …
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RFK Jr’s vaccine overhaul halted by federal judge’s ruling
US health secretary Robert F Kennedy (RFK) Jr’s ongoing overhaul of the vaccine sector in the US has hit a …
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FDA accepts Sun Pharma’s Ilumya sBLA for psoriatic arthritis
The US Food and Drug Administration (FDA) has accepted for review Sun Pharmaceutical’s supplemental biologics licence application (sBLA) submitted for …
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Sentynl and PRG partner for Progerinin licence
Zydus Lifesciences subsidiary Sentynl Therapeutics has signed an agreement with Korean company PRG S&T to license Progerinin (SLC-D011), an investigational molecule …
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Most London patients go private to access weight loss drugs
The majority of patients in London taking weight loss medications are doing so privately, with slow rollouts meaning only a …
