U.S Govenment Announces $450M Deal With Regeneron Pharmaceuticals

U.S Govenment Announces $450M Deal With Regeneron Pharmaceuticals

The combined forces of the Biomedical Advanced Research and Development Authority (BARDA), the U.S. Department of Health and Human Services, and the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense have just approved a $450M deal with Regeneron Pharmaceuticals, Inc. This $450 million contract is for Regeneron to manufacture and supply REGN-COV2. REGN-COV2 is Regeneron's investigational double-antibody cocktail for COVID-19 treatment and prevention. Regeneron is currently in Phase 2/3 of clinical trials for the...

patients demand pharma pricing transparency

Patients Demand Pharma Pricing Transparency

Patients want transparency.  In recent years, patients are facing higher deductibles and higher premiums according to the Kaiser Family Foundation, KFF. Patients are also seeing complex and unclear pricing when it comes to routine checkups and medical tests.  In some cases, these complex pricing databases help knowledgeable patients compare prices refeeding medical procedures. In most cases, most about pricing in the big pharma world are still a mystery to them. More patients demand pharma pricing transparency than ever. Most of...

Lawmakers Urge HHS To Increase Clinical Lab Funding

Lawmakers Urge HHS To Increase Clinical Lab Funding

Due to the extensive work that clinical laboratories have been doing towards the COVID-19 relief, lawmakers urge HHS To increase clinical lab funding. They're urging Secretary Alex Azar of Health and Human Services to direct funds from the Public Health and Social Services Emergency Fund, PHSSEF, to financially support these labs.  These labs are doing extensive research on the COVID-19 testing forefront. It is vital for these labs to have the finances and support needed to accurately and efficient test...

CA and NY Voting on Additional COVID 19 Lab Funding

In recent news, Tom Reed (NY-23) and Scott Peters (CA-52) sent a request asking HHS to allocate a portion of the Public Health and Social Services Emergency Fund, PHSSEF, toward the clinical labs that have been testing extensively for COVID-19. There has since been a need in CA and NY for additional COVID 19 lab funding. Reed describes that these clinical labs have stepped up during this pandemic, including significant investments done to increase the capacity of these tests. He...

COVID-19 Funds To Go Directly to Labs

US Congress Wants COVID-19 Funds To Go Directly to Labs

There are efforts being made by 30 US Congress members who want COVID-19 funds to go directly to labs focusing on COVID-19 testing. Already there is an act titled, Paycheck Protection Program and Health Care Enhancement Act, which invests $25 billion to further research aspects of COVID-19 testing. While this money goes to states in order to enhance their testing abilities, there have been zero federal funds reserved for the labs that have stepped up their facilities including, buying PPE...

Flood of Different COVID-19 Serology Tests Bad News for Clinical Labs

Flood of Different COVID-19 Serology Tests Bad News for Clinical Labs

Is the flood of different COVID-19 serology tests bad news for clinical labs? Yes and no. Clinical laboratory managers and pathologists are well aware of the big undertaking it can be to select, validate, and implement a new COVID-19 serology test. The tests are brand new and abundant, and accuracy is an issue.  But, a pro of these serology tests is the abundance of testing means an opportunity for financial gains, especially for labs with shelter-in-place orders since early March. ...

Pandemic Tips from Healthcare Professionals

COVID-19 has caused countless issues for labs, hospitals, and healthcare providers. Supply shortages, testing delays, and lack of safety equipment have been a few of the daily issues. This blog will list some pandemic tips from healthcare professionals. Becker's Hospital Review hosted a podcast offering advice from industry leaders on how they're coping. Here are some of the highlights: Lab supply chain Bryan Vaughn, senior vice president of hospital and health services at LabCorp: "At LabCorp, choice of [testing] platform to bring...

Are Serological Antibody Tests the Next Step in Countering the Spread of COVID-19?

In order to determine how widespread COVID-19 has become, medical laboratories and In Vitro Diagnostics (IVD) companies are in the midst of developing serological survey testing. This type of testing would be able to detect whether a person’s immune system has developed antibodies to counteract the SARS-CoV-2 virus. In turn, this could also give insight into the infection rates of entire populations.  Because of the delay from the time of infection to when the body begins developing antibodies, these tests...

FDA Relaxes Rules Around Drugs Needed for COVID-19 Ventilator Patients

In light of a shortage of drugs needed for COVID-19 ventilator patients, the Food and Drug Administration (FDA) is not taking action against compounding pharmacies that make copies of approved drugs, use bulk ingredients that are unapproved, or fail to meet manufacturing requirements for stability. The primary reason for relaxing these regulations is to make treatment options available to hospitals that can not obtain FDA-approved drugs. The new rules apply only to outsourcing facilities, and not to smaller compounders that...

The FDA Swiftly Shuts Down Direct-to-Consumer Testing Options for COVID-19

The U.S. Food and Drug Administration took action just ten days after learning about new direct-to-consumer (DTC) testing schemes. Lab companies were selling COVID-19 tests straight to consumers who were promised that the samples they collected themselves would be tested at Clinical Laboratory Improvement Amendments (CLIA)-certified labs.  Although the at-home tests for COVID-19 would seem to be a good option to increase nation-wide testing, the problem lies with the collection of the sample by the consumer. Specimen quality concerns are...