FDA Approves First Treatment For MASH Liver Disease
The drug, called Rezdiffra, is manufactured by Madrigal Pharmaceuticals. Separately, Gilead Pharmaceuticals says it will be able to quadruple production of its CAR-T cancer therapy by 2026 due to manufacturing process improvements.
Stat:
First U.S. Drug Developed To Treat Liver Disease MASH Is Approved
The Food and Drug Administration on Thursday approved the first medicine developed specifically to treat the serious liver disease known as MASH. The pill, called Rezdiffra, is made by Madrigal Pharmaceuticals. (Feuerstein, 3/14)
Reuters:
Gilead CAR-T Cancer Therapy Capacity To Quadruple By 2026
Gilead Sciences will be able to quadruple production of its cell therapy cancer treatments by 2026 due to improvements in the U.S. biotech's manufacturing processes, an executive in charge of that business told Reuters. (Erman, 3/15)
Axios:
Safety Risks Hang Over CAR-T Therapies For Myeloma
Food and Drug Administration advisers Friday will weigh the risk of premature patient deaths from adverse events when they consider expanding the use of two CAR-T therapies for multiple myeloma. (Reed, 3/15)
Stateline:
New Way For States To Cover Pricey Gene Therapies Will Start With Sickle Cell Disease
The new sickle cell treatments have brought hope to those with the debilitating blood disorder, which is hereditary and disproportionately affects Black people. But the therapies come with a price tag of as much as $3 million for a course of treatment, which can take up to a year. Despite those high upfront costs, cell and gene therapies have the potential to reduce health care spending over time by addressing the underlying cause of the disease. (Hassanein, 3/14)
The Washington Post:
Ibogaine Is Hailed For Healing Powers. U.S. Patients Ask Why It’s Illegal
The increased interest in ibogaine arrives amid urgent efforts to ease the nation’s deadly addiction crisis and comes as companies race to develop psychedelics to treat mental health ailments. In Ohio, a prominent ibogaine advocate in February partnered with a nonprofit that supports people with addiction and called for using state opioid-settlement money to study the drug. It mirrors a much-publicized plan in Kentucky that sought to allocate up to $42 million in settlement money for research, an effort that fizzled amid shifting politics. (Ovalle and Gilbert, 3/14)
Stat:
Ebola: Gilead Sciences Antiviral Shows Promise As New Treatment
Anew study suggests the antiviral drug obeldesivir may be effective in curing Ebola Sudan infections, for which there are currently no approved vaccines or treatments. (Branswell, 3/14)