Patient Centered Care

Pharmaceutical Supply Chain Needs Reform for Transparency, Access

by Samantha McGrail

The US pharmaceutical supply chain must be remodeled to address long-standing conflicts and achieve a delivery model marked by transparency, affordability, and access to care, according to an expert...

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...

BioNTech to Acquire Kite’s TCR Platform for Cell Therapy Pipeline

by Samantha McGrail

BioNTech recently entered into an agreement with Kite, a Gilead subsidiary, to acquire its solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility to...

Eli Lilly Enters Pharma Acquisition Deal for Diabetes Treatment

by Samantha McGrail

Eli Lilly and Company recently entered into a pharma acquisition deal with biotechnology company, Protomer Technologies, to advance treatment for type 1 diabetes (TD1).   Protomer...

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...

Moderna Doses First Patient in Study of Flu mRNA Vaccine Candidate

by Samantha McGrail

Moderna recently announced that the first patient has been dosed in the Phase 1/2 study of its quadrivalent seasonal flu mRNA vaccine candidate. mRNA-1010 is Moderna’s first seasonal flu vaccine...

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...

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...

Higher Dose of Ozempic Further Advances Diabetes Care Management

by Samantha McGrail

Novo Nordisk recently announced that a 2.0-milligram dose of Ozempic elicited a “statistically significant and superior” reduction in HbA1C compared to Ozempic 1.0 milligram in...

Walmart Analog Insulin to Streamline Diabetes Care Management

by Samantha McGrail

Walmart recently announced the first-ever private brand analog insulin to revolutionize diabetes care management and offer customers significant price savings without compromising overall...

FDA Approves Boehringer’s Pediatric Oral Blood Thinner

by Samantha McGrail

FDA recently approved Boehringer Ingelheim Pharmaceuticals Pradaxa, the first oral blood thinning medication for children three months to less than 12 years old with venous thromboembolism. Pradaxa...

Gilead’s Remdesivir Lowers Risk of Mortality in COVID-19 Patients

by Samantha McGrail

Gilead recently announced that its COVID-19 treatment, remdesivir, lowered the risk for mortality compared with matched controls in patients hospitalized with the virus. The three real-world data...

Thermo Fisher Uses Next-Generation Sequencing to ID COVID Variants

by Samantha McGrail

Thermo Fisher Scientific recently launched the Ion AmpliSeq SARS-CoV-2 Insight Research Assay to improve surveillance and identification of new and known COVID-19 variants from samples with lower viral...

Congress Reintroduces PASTEUR Act to Combat Antimicrobial Resistance

by Samantha McGrail

US Senators Michael Bennet and Todd Young, and Representatives Mike Doyle and Drew Ferguson recently reintroduced the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act to...

Regeneron’s COVID-19 Antibody Cocktail Reduces Death by 20%

by Samantha McGrail

Regeneron recently announced that its COVID-19 antibody cocktail, REGEN-COV, reduced risk of death by 20 percent in patients hospitalized with COVID-19 who had not mounted their own immune...

FDA Guidance Addresses Patient Outcomes in Cancer Clinical Trials

by Samantha McGrail

FDA has released draft guidance that provides recommendations to sponsors about which patient-reported outcomes (PRO) concepts to measure in cancer clinical trials.  The guidance, Core...

FDA Approves Novo Nordisk’s Obesity Drug Wegovy

by Samantha McGrail

FDA recently approved Novo Nordisk’s Wegovy obesity drug for chronic weight management in overweight adults with at least one weigh-related condition, including high blood pressure, type 2...

FDA Approves First Targeted Non-Small Cell Lung Cancer Therapy

by Samantha McGrail

FDA recently approved Amgen’s Lumakras, the first treatment for adult patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation and who have received at least...