17
Jan
2022
Tag: pharma
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FDA Finalizes Gene Therapy Guidelines and Adds New Draft Guidance on Orphan Drug Exclusivity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?
2
Mar
2020
Bionest
New Treatment Options for Hemoglobin-Based Blood Disorders
Sickle cell disease is a group of inherited disorders that affects hemoglobin, the oxygen-carrying protein in red blood cells (RBCs), and causes these cells to distort in shape at low oxygen levels. This condition affects 1 in 500 Americans of African descent and 1 in 1,000-1,400 of Hispanic descent, as well as millions...
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?
8
Jan
2020
Bionest
The Changing Landscape for Pharma and Physician Interactions
An increasing number of physicians are searching for drug and treatment information on their own, rather than relying on meetings with pharmaceutical sales reps.
2
Dec
2019
Bionest
The Relationship Between ICER and Industry is Evolving
ICER is expected to update the assessment framework underpinning its evidence reports on new drugs and health care interventions at the end of this year. What changes are likely to be made?
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...
21
Oct
2019
Bionest
New Strategies Against a Hard-to-Treat Killer — Pancreatic Cancer
Pancreatic cancer was the third leading cause of cancer-related death in the United States in 2018. This year, experts estimate that 56,770 new cases will be diagnosed and 45,750 deaths will be recorded. Pancreatic cancer is especially lethal because in its early stages, when the disease is easiest to treat, patients are usually asymptomatic. The disease...
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...
30
Sep
2019