Access to Care

HHS Partners with Pharmacies to Boost Access to COVID-19 Vaccines

by Samantha McGrail

HHS recently announced the government’s partnerships with large chain pharmacies and networks to boost access to COVID-19 vaccines across the US. The partnership program will cover nearly 60...

HHS, DoD Announce $12.7M Contract to Increase COVID-19 Testing

by Samantha McGrail

HHS and the Department of Defense (DoD) jointly announced a $12.7 million contract to increase domestic production for two rapid point-of-care COVID-19 tests.  The contract is with InBios...

FDA Approves Remdesivir as the First COVID-19 Treatment

by Samantha McGrail

FDA recently approved Verklury as the first COVID-19 treatment. The approval signs off on using the drug also known as remdesivir has been signed in adults and pediatric patients 12 years of age or...

Thermo Fisher Scientific to Expand At-Home COVID-19 Testing

by Samantha McGrail

Thermo Fisher Scientific recently announced it has received an expansion of its emergency use authorization for a COVID-19 testing kit to include an additional sample collection method provided by...

GSK, Vir Biotechnology Expand Phase 3 Study of COVID-19 Antibody

by Samantha McGrail

Vir Biotechnology and GSK recently announced the global expansion of a Phase 3 study evaluating their COVID-19 antibody, VIR-7831. The COMET-ICE study will evaluate VIR-7831 in patients who are at...

Global Effort Aims to Insure Against a Failed COVID-19 Vaccine

by Samantha McGrail

Sixty-four higher-income economies recently joined the COVAX Facility, a global COVID-19 response effort that ensures governments and manufacturers have access to COVID-19 vaccines, according to an...

GSK, Sanofi to Supply 300M Doses of COVID-19 Vaccine to EU

by Samantha McGrail

Sanofi and GSK recently finalized an agreement with the European Commission (EC) for the supply of up to 300 million doses of their COVID-19 vaccine, once the vaccine is approved. The agreement will...

Just Half of Americans Would Get a COVID-19 Vaccine If Ready Today

by Samantha McGrail

Nearly half (51 percent) of Americans said they would definitely or probably get a COVID-19 vaccine if it were available today, while 49 percent said they definitely or probably would not, according to...

Bolstering the Pharmaceutical Supply Chain for a COVID-19 Vaccine

by Samantha McGrail

COVID-19 vaccines are being developed at a quick pace, but a broken supply chain could derail this momentum. A new report from PricewaterhouseCoopers (PwC), however, uncovered three steps drug...

HHS Issues Guidance to Expand Access to COVID-19 Vaccines

by Samantha McGrail

Last week, HHS issued guidance under the Public Readiness and Emergency Preparedness Act (PREP Act) to expand access to safe and effective COVID-19 vaccines when they become available.  The...

FDA Authorizes Faster COVID-19 Antigen Test from Abbott

by Samantha McGrail

FDA recently issued an emergency use authorization to Abbott for the first COVID-19 antigen test where results can be read directly from the testing card.  The BinaxNOW Ag Card is fast and...

How EHR-Based Clinical Trials Can Accelerate Research Strategies

by Samantha McGrail

EHR-based clinical trials can accelerate the pace of research discoveries and generate sufficient evidence to inform treatment strategies, according to a recent article from the Clinical Journal...

CMS Seeks Faster Medicare Coverage for Newly Approved Devices

by Samantha McGrail

Today, CMS issued a proposed rule that would create a new, accelerated Medicare coverage process for innovative products that FDA deems “breakthrough,” including new implants or gene-based...

FDA Approves New Opioid For Intravenous Use in Hospitals

by Samantha McGrail

FDA recently approved Trevena Inc.’s Olinvyk (oliceridine), an opioid used to manage severe acute pain in adults who require an intravenous opioid and who have been unresponsive to alternative...

FDA Requires Drug Manufacturers to Update Opioid Labels

by Samantha McGrail

FDA recently announced that it is requiring label changes for opioid pain medicines and medicines used to treat opioid use disorder (OUD). Updated labels for the prescription drugs will need to say,...

Emergency Use Authorization Issued for COVID-19 Pooled Testing

by Samantha McGrail

FDA recently reissued an Emergency Use Authorization (EUA) to Quest Diagnostics for its sample COVID-19 pooled testing tool. For more coronavirus updates, visit our resource page, updated twice...

Oxford Scientists Develop Spinout to Launch COVID-19 Rapid Test

by Samantha McGrail

Scientists from the University of Oxford’s Department of Engineering Science and Oxford Suzhou Centre for Advanced Research (OSCAR) recently developed a new company to launch a COVID-19 rapid...

Pfizer, BioNTech Gain FDA Fast Track for COVID-19 Vaccine Candidates

by Samantha McGrail

Pfizer and BioNTech were recently granted FDA Fast Track designation for two of the companies’ four investigational COVID-19 vaccine candidates from their BNT162 mRNA-based vaccine program,...

Pfizer Commits $100M to Help Fight Rise of Antimicrobial Resistance

by Samantha McGrail

Pfizer recently announced that it pledged $100 million to the Antimicrobial Resistance (AMR) Action Fund to address the vital public health need for new antibiotics due to the rapid rise of...

FDA Grants EUA for Becton Dickinson’s Rapid COVID-19 Antigen Test

by Samantha McGrail

FDA recently issued an Emergency Use Authorization (EUA) for a rapid COVID-19 antigen diagnostic test that can be used at the point of care. For more coronavirus updates, visit our resource page,...