Patient Centered Care

Bristol Myers Grants $7.9M to Improve Access to Care Across US

by Samantha McGrail

Bristol Myers Squibb recently granted $7.965 million to 24 US non-profit organizations to improve access to care for medically underserved patients across oncology, cardiology, immunology, and...

Gilead’s COVID-19 Treatment Effective Against Variants of Concern

by Samantha McGrail

Gilead recently announced that its COVID-19 treatment, remdesivir, retained antiviral in vitro activity against variants of concern, including Alpha, Beta, Gamma, Delta, and Omicron. Researchers...

Merck KGaA to Assess Quris AI Platform for Clinical Prediction

by Samantha McGrail

Merck KGaA, Darmstadt, Germany, and Quris recently signed an agreement to assess the Quris BioAI machine learning platform and compare it to traditional in vitro and in vivo approaches. The Quris...

FDA Issues Draft Guidance for Development of Non-Opioid Analgesics

by Samantha McGrail

The FDA recently issued draft guidance to foster the development of non-addictive alternatives to opioids to manage acute pain and prevent new addiction. The guidance provides recommendations to...

Gilead, ViiV Healthcare Enter $1.25B Settlement Over HIV Drug

by Samantha McGrail

ViiV Healthcare, GSK, and Shionogi recently entered a $1.25-billion settlement over the global patent infringement litigation with Gilead concerning its HIV drug combined with three HIV integrase...

Biogen to Develop, Commercialize Genentech’s Bispecific Antibody

by Samantha McGrail

Biogen recently exercised its option to participate in the development and commercialization of Genentech’s bispecific antibody, mosunetuzumab. Mosunetuzumab is a CD20xCD3 T-cell engaging...

Samsung Biologics to Accelerate Growth in Biosimilar Research

by Samantha McGrail

Samsung Biologics will acquire Biogen’s stake in Samsung Bioepis for $2.3 billion to accelerate growth in biosimilars and novel therapeutic research and development. Under the terms of the...

Pfizer Seeks to Amend EUA of COVID-19 Vaccine to Include Children

by Samantha McGrail

Pfizer and BioNTech recently initiated a rolling submission seeking to amend FDA’s emergency use authorization of their COVID-19 vaccine to include children six months to four years of age. The...

FDA Approves Takeda’s Von Willebrand Disease Treatment

by Samantha McGrail

FDA recently approved Takeda Pharmaceutical’sPharmaceutical’s Vonvendi for routine prophylaxis to reduce the frequency of bleeding episodes in patients with severe Type 3 von Willebrand...

Personalized Immunotherapy Could Treat Metastatic Breast Cancer

by Samantha McGrail

Personalized immunotherapy from an individual’s tumor-fighting immune cells could potentially treat metastatic breast cancer, according to a study from the National Cancer Institute’s...

Patient, Prescription-Related Factors Linked to Opioid Overdose

by Samantha McGrail

Patient factors, including Medicaid or Medicare Advantage, comorbid substance use disorder, medical comorbidities, and prescription-related factors, are associated with opioid overdose, according to a...

Former Head of Pharmaceutical R&D of Roche Joins Pfizer

by Samantha McGrail

Pfizer recently announced that it will appoint William Pao, MD, PhD, as executive vice president and chief development officer. Effective March 2022, Pao will replace Rod Mackenzie, who recently...

FDA Grants Full Approval of Moderna’s COVID-19 Vaccine

by Samantha McGrail

FDA fully approves Moderna’s mRNA COVID-19 vaccine, Spikevax, for individuals 18 years of age and older. "The full licensure of Spikevax in the US now joins that in Canada, Japan, the European...

Eli Lilly Invests $1B in Facility to Boost Access to Medicine in NC

by Samantha McGrail

Eli Lilly and Company recently announced plans to invest over $1 billion to create a new manufacturing site and boost access to medicine in Concord, North Carolina. The facility will utilize the...

Moderna, IAVI Dose First Patients in Trial of HIV Vaccine Antigens

by Samantha McGrail

Modern and IAVI recently dosed the first two patients in a clinical trial of experimental HIV vaccine antigens at the George Washington University (GWU) School of Medicine and Health Sciences. The...

Opioid Use Disorder Medicine Lacking for Pregnant Women in US Jails

by Samantha McGrail

Most pregnant and postpartum women with opioid use disorder (OUD) in US jails do not receive medication that is standard of care, a JAMA Network Open study found. The cross-sectional study surveyed...

Regeneron Gets FDA Review for Non-Small Cell Lung Cancer Treatment

by Samantha McGrail

FDA recently accepted for review Regeneron’s biologics license application for its PD-1 inhibitor, Libtayo, in combination with chemotherapy to treat advanced non-small cell lung cancer...

2020 Drug Price Increase Driven by Generic Drugs, Biosimilars

by Samantha McGrail

The estimated drug price inflation rate for this year is expected to have a moderate price increase, according to Vizient’s 2022 Pharmacy Market Outlook. The Vizient Pharmacy Program looked at...

FDA Expedites Approval of Gilead’s COVID-19 Treatment, Remdesivir

by Samantha McGrail

FDA recently expedited approval of Gilead’s new drug application for its COVID-19 treatment, Veklury (remdesivir). The agency expanded the drug to non-hospitalized adults and adolescent patients...

FDA Grants Clearance to Biotricity’s Arrhythmia Monitoring Device

by Samantha McGrail

FDA recently granted 510(k) clearance to Biotricity’s Biotres Cardiac Monitoring Device for ECG and arrhythmia monitoring. Biotres Cardiac Monitoring Device offers a wearable Holter patch device...