- The FDA has issued two guidance documents that it says should help make the drug development process more efficient.
- The first addresses the use of minimal residual disease (MRD) as a biomarker in clinical trials for certain blood cancers. The agency believes it clarifies how best to use MRD as a general measure of tumor burden or assess the likelihood of relapse.
- The second is final guidance on the regulatory framework for finding treatments that address underlying molecular changes that cause or contribute to disease (e.g., gene therapies). It includes an approach for drug developers for enrolling patients with rare genetic variants in clinical trials and the evidence required to demonstrate efficacy.
- Selected tickers: BIB, GRX, THW, BME, BIS, IXJ, ARKG, CHNA, XLV, XBI, IBB, XBI, XPH, IHE, PPH, VHT, OTCQX:RHHBY, ABBV, AGN, AZN, BMY, GSK, JNJ, MRK, NVS, BHC, TEVA, AMGN, BIIB, GILD, VRTX, OTCPK:TKPYY, ESRX, WBA, CVS, UNH, PFE, CELG
- Now read: THW: A Comforting Healthcare Fund In A Turbulent Market
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