This edition of the Innovation Partners BioBlog looks at cancer care in the era of COVID-19. ASCO released guidelines to help hospitals apportion scarce resources among critically ill patients, including cancer patients, during the pandemic. A new approach to prostate cancer drugs may delay drug resistance during treatment. The FDA has cleared more foreign generic drug plants for production to secure the supply chain, and the Trump administration has passed two laws ensuring that Americans with health insurance will find their COVID-19 testing and treatment covered by insurance. You’ll find more coverage of the top healthcare industry stories in this week’s BioBlog.
FDA clears wave of foreign manufacturing plants as COVID-19 concerns continue to grow
The FDA has cleared many new foreign manufacturing plants as concerns continue about the flow of medications from the global supply chain during the coronavirus pandemic. Many overseas factories produce generic drugs for the United States. Three new companies in India and Malaysia received FDA clearance to begin production: Lupin Pharmaceuticals, Dr. Reddy’s Laboratories and Biocon. A fourth, Strides Pharma, received an EIR for its facility in Bangalore, India.
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How a Premier U.S. Drug Company Became a Virus ‘Super Spreader’
Biogen, a U.S. drug company based in Boston, became the unlikely locus of coronavirus after a companywide meeting in March sent attendees home with an unexpected hitchhiker: COVID-19 infections. Despite rumblings that the virus had reached the United States and was likely to be highly infectious, Biogen’s leaders went ahead with a planned meeting that became known as a ‘superspreader’ event when employees returned home, bringing the virus to six states.
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EXCLUSIVE: AstraZeneca’s Calquence Shows Early Promise For COVID-19 Patients
AstraZeneca’s blood cancer drug, Calquence, has shown promising results in the treatment of late-stage COVID-19 patients. Two drugs, Calquence and Imbruvia, a drug for the treatment of leukemia, have both shown promise for getting coronavirus patients off of ventilators. Once COVID-19 patients require a ventilator, they have only a 50% chance of survival. Walter Reed Medical Center, a U.S. Army hospital, has been experimenting with the use of Calquence for severely ill COVID-19 patients. Patients have shown a ‘material improvement’ with the off-label use of the drug. Both drugs block Bruton’s tyrosine kinase (BTK), a protein that signals the white blood B cells into action. This action might calm the cytokine storm, an out of control immune response seen in the hardest hit COVID-19 patients.
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Trump administration issues guidance on coverage mandates in COVID-19 legislation
Two legislative packages intended to fight the COVID-19 outbreak passed last week. Under the new legislation, commercial health plans will be required to cover testing for the virus. All visits to doctor’s offices, clinics, or hospitals, whether in-person or telehealth, related to COVID-19, will also be covered. And finally, the Centers for Medicare & Medicaid Services said that the mandates will extend to antibody testing once it’s made more readily available.
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Walgreens expands telehealth as COVID-19 demands social distancing
Walgreens has updated its Walgreens First Care platform available on mobile devices and a website to include a COVID-19 risk assessment. The virtual risk assessment, created by the same Microsoft bot that runs Microsoft Azure, is based on CDC guidelines. Patients can also use the Walgreens app and website to find clinical trials related to COVID-19 treatment. National and regional partners have been added for patients to virtually connect with more than 30 providers, including many in states currently most impacted by COVID-19, such as New York, California, Illinois, New Jersey, Michigan and Florida.
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New Guidance Released for Oncology Community on Allocation of Limited Resources During COVID-19 Pandemic
Healthcare institutions across the United States face difficult decisions as they wrestle with how to use scarce resources for all patients during the COVID-19 epidemic. This includes oncology patients, who may be among the most vulnerable due to compromised immune systems. Now, ASCO, the American Society of Clinical Oncology, has released a set of guidelines to help hospitals make decisions regarding cancer patient care during the pandemic. In some geographic areas, the ongoing crisis is expected to demand more resources, including ventilators, critical and intensive care beds, and medications,than the U.S. or local health care systems can supply. Many institutions will need to develop allocation decision policies as they provide care for a growing number of critically ill patients.
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Moffitt Researchers Develop Mathematical Model to Predict Patient Outcomes to Adaptive Prostate Cancer Therapy
Prostate cancer is the second-most common malignancy in the United States. Many patients develop drug resistance during treatment. Researchers at the Center of Excellence for Evolutionary Therapy at Moffitt Cancer Center believe that adaptive treatments may be an effective approach. These treatments, based on evolutionary principles, may prevent drug resistant or delay it and thus prolong patient survival. Data shows that individual patient alterations in the prostate-specific antigen (PSA) biomarker early in treatment can predict outcomes to later treatment cycles of adaptive therapy. These models could eventually be used to devise patient specific treatments according to changing tumor growth and biomarker patterns.
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