Access to Care

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...

HHS Expands Workforce Authorized to Administer COVID-19 Vaccines

by Samantha McGrail

HHS recently issued a fifth amendment to the Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act) to add categories of qualified persons authorized to prescribe,...

GSK, Novartis to Study Genetic Diversity for Drug Development

by Samantha McGrail

GSK and Novartis recently announced a research collaboration to uncover potential links between genetic diversity across regions in Africa and drug response and ultimately drug development. The...

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...

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...

US to Remain WHO Member, Join Global COVID-19 Vaccine Program

by Samantha McGrail

The US will remain a member of the World Health Organization (WHO) under President Joe Biden and will join COVAX, a global COVID-19 vaccine program led by WHO, NIAID Director Anthony Fauci, MD, said in...

Biden Executive Order Details New COVID-19 Response Plan

by Samantha McGrail

President Joe Biden recently signed an executive order to combat COVID-19 and prepare for future biological and pandemic threats.  “The Federal Government must act swiftly and aggressively...

HHS Expands Access to Buprenorphine for Opioid Use Disorder

by Samantha McGrail

HHS recently announced that it will expand access to medication-assisted treatment (MAT) for opioid use disorder. Under the agency’s guidelines, Practice Guidelines for the Administration for...

Second COVID-19 Antibody from Vir, GSK Enters Phase 1b Trial

by Samantha McGrail

Vir Biotechnology and GSK recently announced an agreement with UK-based AGILE initiative to evaluate the company’s COVID-19 antibody, VIR-7832, in a Phase 1b/2a clinical trial. The AGILE trial...

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,...

Kite, Oxford BioTherapeutics Partner to Research Cell Therapies

by Samantha McGrail

Kite, a Gilead Company, and Oxford BioTherapeutics recently entered into a collaboration to research and evaluate five novel cell therapies for hematologic and solid tumor indications.  Oxford...

FDA Issues EUA for Abbott’s At-Home COVID-19 Antigen Test

by Samantha McGrail

FDA recently issued an emergency use authorization (EUA) for Abbott’s COVID-19 antigen test, the BinaxNOW COVID-19 Ag Card Home Test, for use by patients with a prescription.  The test is...

Cerner Invests in Elligo to Boost Access to Clinical Trials

by Samantha McGrail

Cerner recently announced that an investment in Elligo Health Research will increase access to clinical trials by offering clinical trial resourcesin the Cerner Learning Health...

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...

HHS Ensures Access to COVID-19 Vaccines for Tribal Health Programs

by Samantha McGrail

HHS recently announced that all tribal health programs and Urban Indian Organizations (UIOs) have chosen their preferred method for receiving a COVID-19 vaccine. Tribal health programs and UIOs have...

FDA Authorizes First Influenza, COVID-19 Diagnostic Test

by Samantha McGrail

FDA recently authorized the first at-home influenza and COVID-19 diagnostic test intended for patients who are suspected of respiratory viral infection consistent with the coronavirus.  The test,...

Roche Receives FDA Approval for COVID-19 Antibody Test

by Samantha McGrail

Roche recently announced that its COVID-19 antibody test, Elecsys, received FDA emergency use authorization. Elecsys Anti-SARS-CoV-2 S measures the level of antibodies to the spike protein of...

HHS, DoD to Increase Domestic Swab Production for COVID-19 Tests

by Samantha McGrail

HHS and the Department of Defense (DoD) recently awarded an $11.6 million contract to Puritan Medical Products Company, LLC to boost domestic production of nasal swabs used for COVID-19 tests. The...

New PhRMA Guidelines Aim to Improve Clinical Trial Diversity

by Samantha McGrail

The Pharmaceutical Research Manufacturers of America (PhRMA) recently announced the release of industry-wide principles on clinical trial diversity. The principles focus on four areas, including...

Amazon Launches Its Own Pharmacy, Prescription Delivery Service

by Samantha McGrail

Amazon is moving into the pharmacy business by launching its own online pharmacy and prescription delivery services, the company recently announced. The first offering, Amazon Pharmacy, allows...