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Sanofi’s Sarclisa wins in transplant-eligible multiple myeloma trial

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Sanofi’s Sarclisa (isatuximab) plus standard of care has been shown to extend the time that some multiple myeloma patients remain stable without disease progression. This was demonstrated in a Phase III trial (NCT03617731) with 662 newly diagnosed patients who were eligible for a stem cell transplant. The trial found that adding Sarclisa to the standard drugs – lenalidomide, bortezomib, and dexamethasone (Rvd) – resulted in a statistically significant and clinically meaningful improvement in progression-free survival compared to RVd induction therapy. Sanofi said that these results reinforce the potential of Sarclisa as a backbone therapy when added to the current standard of care in various multiple myeloma patient populations. These recent findings build on data from 2021, where the trial met a different primary endpoint of minimal residual disease (MRD) negativity after induction therapy and before transplant. Around 50.1% of the newly diagnosed multiple myeloma patients achiev...
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MDMA Papers Retracted for ‘Unethical Conduct’ on Heels of Lykos’ FDA Rejection

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A day after the regulator denied approval of Lykos’ MDMA-assisted PTSD therapy, a medical journal pulled three studies related to the use of the psychedelic in the indication. The medical journal Psychopharmacology on Saturday retracted three papers related to the use of the psychiatric substance MDMA for the treatment of post-traumatic stress disorder. The decision to pull the studies was driven by “protocol violations amounting to unethical conduct” at one of the study sites, according to the journal’s retraction note. The authors of the studies also confirmed to Psychopharmacology that they knew of these breaches when they submitted their manuscript “but did not disclose this information to the journal or remove data generated by this site from their analysis.” Many of the authors failed to fully disclose a “potential competing interest, ” according to the retraction notice, while some of the researchers were affiliated with either the Multidisciplinary Association for Psychedelic...
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Cell and gene therapy companies must demonstrate strong value proposition for investment

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Investment for companies developing cell and gene therapies (CGTs) was discussed during the GenScript Biotech Global Forum London 2024 conference held on 20 November 2024. Following a sharp drop in CGT investment in 2022, trends suggest that CGT investment is currently undergoing a “renormalisation”. However, investors continue to be selective, said speakers Josh Resnik, senior managing director at RA Capital Management, and Ping Shek, managing director at Stifel’s Healthcare Investment Banking Division. CGTs have faced challenges attracting investment due to the large amount of capital required to manufacture CGTs, as well as hurdles relating to reimbursement of one-off, high-cost therapies and patient access. Resnik noted that investor sentiment about CGTs was impacted by competitive pressures from “not-so-complicated biologics” such as antibody-drug conjugates, radiopharmaceuticals, and T-cell engagers in oncology and immunology. Resnik noted that CGTs must demonstrate a stron...
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