Research & Evidence

Biogen’s Alzheimer’s Disease Drug Safe, Effective in Trial

by Samantha McGrail

Biogen recently announced that its Alzheimer’s disease drug, BIIB080, was safe and well-tolerated in patients with mild disease. The drug was developed in partnership with Ionis...

FDA Approves Mylan’s Interchangeable Biosimilar Insulin Product

by Samantha McGrail

FDA recently approved Mylan’s interchangeable biosimilar insulin product, Semglee, to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with...

AbbVie, Calico Extend Partnership for Age-Related Disease Therapies

by Samantha McGrail

AbbVie and Calico Life Sciences recently extended their collaboration to discover, develop, and bring new therapies to market for patients with age-related diseases, including neurodegeneration and...

FDA Approves Merck’s Keytruda Treatment for Endometrial Carcinoma

by Samantha McGrail

FDA recently approved the combination of Merck’s monoclonal antibody, Keytruda, and Eisai’s tyrosine kinase inhibitor, Lenvima, for the treatment of patients with advanced endometrial...

Bristol Myers Squibb Pulls Immunotherapy Opdivo from US Market

by Samantha McGrail

Bristol Myers Squibb recently announced its voluntarily withdrawal of the indication for Opdivo, its single-agent immunotherapy for patients with hepatocellular carcinoma (HCC), from the US...

Pfizer, Arvinas to Develop Protein Degrader for Breast Cancer

by Samantha McGrail

Pfizer and Arvinas recently entered into a global collaboration to develop and commercialize an investigation oral PROteolysis Targeting Chimera (PROTAC) estrogen receptor (ER) protein degrader for...

FDA Grants Breakthrough Therapy for Roche’s MDS Treatment

by Samantha McGrail

Roche recently announced that FDA granted breakthrough therapy designation for its combination myelodysplastic syndromes (MDS) treatment. The treatment combination of Venclexta and azacitidine is...

High-Dose Buprenorphine Helped Untreated Opioid Use Disorder

by Samantha McGrail

High-dose buprenorphine induction was safe and well-tolerated in patients with untreated opioid use disorder, according to a JAMA Network Open study.  Researchers gathered data from electronic...

Lilly Enters Collaboration for Phase 3 Trial of Alzheimer’s Drug

by Samantha McGrail

Eli Lilly and Company and Banner Alzheimer’s Institute recently entered into a research collaboration as part of the planned Phase 3 clinical trial evaluating Lilly’s Alzheimer’s...

FDA Approves Sanofi’s All-Oral Treatment for Sleeping Sickness

by Samantha McGrail

FDA recently approved Sanofi’s Fexinidazole, the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness. The agency approved Fexinidazole for...

Pfizer Completes Trial Enrollment for Lyme Disease Vaccine

by Samantha McGrail

Pfizer and Valneva recently completed recruitment for the Phase 2 clinical trial of Lyme disease vaccine candidate, VLA15.  The trial, VLA15-221, builds on previous positive Phase 2 trials and...

J&J COVID-19 Vaccine Elicits Antibody Responses Against Variants

by Samantha McGrail

Johnson & Johnson recently announced that its COVID-19 vaccine elicited strong antibody and T-cell immune responses as long as eight months after vaccination. The results, published in the New...

Biogen, InnoCare Pharma Partner for Multiple Sclerosis Treatment

by Samantha McGrail

Biogen and InnoCare Pharma Limited recently entered into a license and collaboration agreement for orelabrutinib, a potential multiple sclerosis (MS) treatment. Orelabrutinib is a small molecule...

FDA Authorizes Ortho Clinical’s COVID-19 Antibody Test

by Samantha McGrail

FDA recently granted emergency use authorization to Ortho Clinical Diagnostics’ COVID-19 antibody test for use as an aid in identifying individuals with adaptive immune responses to the...

Study Finds Major Medicare Overspending Generic Prescription Drugs

by Samantha McGrail

Medicare overspent by 13.2 percent in 2017 and 20.6 percent in 2018 compared with Costco pharmacy member prices for the most commonly prescribed generic prescription drugs, according to a JAMA Network...

Medicare Prescription Drug Prices Doubled Since 2005

by Samantha McGrail

Launch prices for prescription drugs have doubled since 2005, according to researchers from Duke University’s Fuqua School of Business. David Ridley, health economist and Fuqua strategy...

FDA Seeks Investigation Over Approval of Alzheimer’s Drug, Aduhelm

by Samantha McGrail

FDA has called for a government investigation into the approval of Biogen’s Alzheimer’s drug, Aduhelm, according to multiple news sources.  Experts recently discovered an unreported...

Pfizer, AbbVie, Biogen Launch Resource for Genetic Variants

by Samantha McGrail

Pfizer, AbbVie, and Biogen recently launched the world’s largest browsable resource linking rare protein-coding genetic variants to human health and disease.  The genetic exome sequence...

Thermo Fisher, UC Davis Launch Center of Excellence for Metabolomics

by Samantha McGrail

Thermo Fisher Scientific and UC Davis recently launched The Center of Excellence in Clinical Metabolomics to support the rapid scale-up of large cohort studies and clinical research. The Center of...

FDA: Aduhelm Only to Be Given to Early-Stage Alzheimer’s Patients

by Samantha McGrail

FDA recently reversed its broad approval for Biogen’s Alzheimer’s drug, Aduhelm, after being approved just last month, according to multiple news outlets.  The agency now recommends...