Bionest

Psychedelic Drug Research Making a Comeback

In the 1950s and early 1960s, researchers within both academic and governmental institutions extensively investigated the clinical potential of psychedelic drugs, notably both LSD and psilocybin, the psychoactive substance in “magic mushrooms.” This early research aimed to understand the biological underpinnings of schizophrenia and to find new treatments for psychological disorders such as depression, anxiety...

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Long Awaited CMS Rules on Medicare Coverage for CAR-T Therapies

In August, the Centers for Medicare and Medicaid Services (CMS) finalized long-sought rules framing the coverage of chimeric antigen receptor T-cell (CAR-T) treatments. Two CAR-T therapeutics are currently on the market: Gilead’s Yescarta and Novartis’ Kymriah, both approved for diffuse large B-cell lymphoma (DLBCL) with the latter also approved for acute lymphocytic leukemia (ALL). Under...

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New Approvals for Tumor-Agnostic Cancer Treatments — and the Questions They Raise

On August 15, the U.S. Food and Drug Administration granted accelerated approval to Genentech/Roche’s Rozlytrek (entrectinib) for the treatment of adult and adolescent patients with solid tumors that exhibit neurotrophic tyrosine receptor kinase (NTRK) fusions and for whom there are no existing effective treatments. While NTRK fusions are rare, appearing in about 1% of solid...

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Focusing on NASH

Non-alcoholic fatty liver disease (NAFLD), the build-up of fat in the liver that is not caused by alcohol, affects almost 100 million people in the United States alone. With no drug therapies available for the condition, treatment has focused mostly on weight loss. The more severe form of NAFLD, non-alcoholic steatohepatitis (NASH), causes the liver...

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Zolgensma Launch “On Track,” but Significant Challenges Remain

On July 18, Novartis told analysts its Zolgensma launch was “on track.” Despite the gene therapy’s $2.1 million price tag, the company states the launch is “one of the most successful launches from an access standpoint in rare diseases.” Novartis said it had reached coverage deals with more than 20 commercial insurance plans, covering approximately 40%...