27
Apr
2020
Tag: FDA
13
Apr
2020
Bionest
FDA Finalizes Gene Therapy Guidelines and Adds New Draft Guidance on Orphan Drug Exclusivity
The field of gene and cell therapy is flourishing. How is the FDA responding?
17
Feb
2020
Bionest
New Treatments for Alzheimer’s Disease? Maybe.
No new treatments for Alzheimer’s disease have been approved since 2003. What's on the horizon?
16
Dec
2019
Bionest
New Risk-Based Oversight of Software as a Medical Device
A review of new FDA draft guidance documents that describe how the agency plans to regulate software designed to aid clinical decision making.
9
Dec
2019
Bionest
First Peanut Allergy Immunotherapeutic Recommended for FDA Approval
No standardized oral immunotherapeutics have existed for peanut allergies. Could this soon change?
4
Nov
2019
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...
28
Oct
2019
Bionest
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...
7
Oct
2019
Bionest
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...
16
Sep
2019
Bionest
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...
2
Sep
2019