Patient Centered Care

CDC Advisors Recommend Johnson & Johnson COVID-19 Vaccine

by Samantha McGrail

Johnson & Johnson recently announced that the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended its single-shot COVID-19 vaccine under the recent FDA emergency use...

GSK Antibody Helps Combat Respiratory Failure from COVID-19

by Samantha McGrail

GSK recently announced results from a Phase 2 proof-of-concept trial evaluating its investigational monoclonal antibody treatment, otilimab.  The OSCAR study evaluated the efficacy and safety of...

FDA Issues New Guidance for COVID-19 Vaccine Developers

by Samantha McGrail

FDA recently issued three guidance documents for COVID-19 vaccine developers and other medical product creators covering to address the current and potential future emergence of variants of...

FDA Approves Bristol Meyers Squibb CAR T Cell Therapy for Lymphoma

by Samantha McGrail

FDA recently approved Bristol Meyer Squibb’s CAR-T cell therapy Breyanzi for the treatment of certain types of large B-cell lymphoma in patients who have not responded to previous treatment...

Roche to Launch Self-Administered COVID-19 Antigen Test

by Samantha McGrail

Roche recently announced that it received the CE mark for its new self-administered COVID-19 antigen test, which will be available in countries accepting the CE mark by the middle of this...

Virtual Clinical Trial Kicks Off in NY to Study COVID-19 Therapy

by Samantha McGrail

The Feinstein Institutes for Medical Research, part of Northwell Health, and Cold Spring Harbor Laboratory (CSHL) recently launched a fully virtual clinical trial to evaluate the safety and efficacy of...

AstraZeneca’s COVID-19 Vaccine 82% Effective After Second Dose

by Samantha McGrail

AstraZeneca recently announced that its COVID-19 vaccine is safe and effective at preventing coronavirus in Phase 3 clinical trials from the UK, Brazil, and South Africa.  The first dose of...

Eli Lilly’s COVID-19 Antibodies Reduce Hospitalizations by 70%

by Samantha McGrail

Eli Lilly and Company recently announced that its COVID-19 neutralizing antibodies reduced coronavirus-related hospitalizations and deaths in high-risk patients by 70 percent in a Phase 3...

Biden’s Executive Order on Expanding Access to COVID-19 Therapies

by Samantha McGrail

President Joe Biden recently signed an executive order to accelerate the development of novel COVID-19 therapies and improve access to care for all Americans.  First, Biden called on the HHS and...

Moderna Doses First Patient in Japanese Study of COVID-19 Vaccine

by Samantha McGrail

Moderna recently announced that clinical trial researchers have dosed the first in the Phase 1/2 study of its mRNA COVID-19 vaccine, mRNA-1273, in Japan, led by Takeda Pharmaceuticals.   The...

Thermo Fisher Inks $450M Deal to Acquire Mesa Biotech

by Samantha McGrail

Thermo Fisher Scientific recently announced that it entered into a $450 million definitive agreement to acquire San Diego-based Mesa Biotech, Inc. and boost the availability of reliable molecular...

Merck Terminates Development of COVID-19 Vaccine Candidates

by Samantha McGrail

Merck recently announced that it is discontinuing development of its COVID-19 vaccine candidates, V590 and V591, and will focus its research strategy on advancing its two other candidates, MK-4482 and...

Pfizer’s COVID-19 Vaccine Elicits Antibodies Against UK Strain

by Samantha McGrail

Pfizer and BioNTech recently announced that its COVID-19 vaccine, BNT162b2, elicited antibodies that neutralize the SARS-CoV-2 UK strain, known as B.1.1.7 lineage.  The in-vitro study...

HHS Distributes $22B to States for COVID-19 Testing, Vaccinations

by Samantha McGrail

HHS recently announced that it will provide more than $22 billion in funding to states, localities, and territories to support COVID-19 testing and vaccination.  Over $19 billion of the funding,...

CA Launches Campaign for Safe, Fair COVID-19 Vaccine Distribution

by Samantha McGrail

California Governor Gavin Newsom recently launched a campaign for safe, fair, and equitable distribution of a COVID-19 vaccine in all 58 counties of the state. The “Vaccinate All 58”...

AstraZeneca Reports Positive Results in Cancer Drug Clinical Trial

by Samantha McGrail

AstraZeneca recently announced that its cancer drug, Calquence elicited positive responses in a Phase 2 clinical trial of mantle cell lymphoma patients.  The Phase 2 trial, ACE-LY-004, uncovered...

Moderna Launches Study of COVID-19 Vaccine in Adolescents

by Samantha McGrail

Moderna recently announced that the first adolescent patients have been dosed in the Phase 2/3 study of its mRNA-based COVID-19 vaccine, mRNA-1273. The randomized, controlled Phase 2/3 study will...

Bayer Launches Cell, Gene Therapy Platform for Pharma Innovation

by Samantha McGrail

Bayer recently announced the launch of a cell and gene therapy platform (C&GT) within its pharmaceutical division. The platform will further consolidate its emerging leadership in the cell and...

Vaccination Implementation As Vital As Drug Efficacy, Study Finds

by Samantha McGrail

The implementation of a COVID-19 vaccination program will contribute more to the success a vaccine than drug efficacy, according to a recent Health Affairs study. The study’s findings could...

Eli Lilly, Precision to Research Gene Therapies for Genetic Disorders

by Samantha McGrail

Eli Lilly & Company and Precision BioSciences recently announced a collaboration to research and develop potential in vivo gene therapies for genetic disorders. The collaboration and exclusive...