Pfizer Refutes Moderna’s Claim That It Infringed On mRNA Vaccine Patents

Moderna is suing Pfizer and BioNTech alleging that the companies copied two key features of Moderna’s patented mRNA technology and used it to make their COVID-19 vaccine, Comirnaty, but Pfizer refuted those claims, telling Inside Health Policy Comirnaty was made with BioNTech’s proprietary mRNA technology. Pfizer added that it is confident in its intellectual property for the two-dose Pfizer-BioNTech vaccine and will “vigorously defend” against Moderna’s allegations. “Pfizer/BioNTech has not yet fully reviewed the complaint, but we are surprised...
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InsideHealthPolicy.com
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Breaking COVID-19 Vaccine News
FDA Issue: 
FDA Week - 09/02/2022
FDA Volume: 
Vol. 28, No. 35
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FDA: Investigational Drug Costs May Be Spread Out

The cost of providing investigational new drugs in clinical trials or expanded access programs may spread out to all patients who are expected to receive the products over time, rather than charging a higher price to patients who receive drugs in the first year of IND or expanded access programs, FDA says in a revised guidance published Tuesday (Aug. 23). The agency’s recommendation is part of a revised guidance, “Charging for Investigational Drugs Under an IND Questions and Answers,” that...
Article Type: 
Site Name: 
InsideHealthPolicy.com
IDP Issue: 
Inside Drug Pricing - 08/29/2022
IDP Volume: 
Vol. 5, No. 35
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Stakeholders Unite To Press Senate On Telehealth Extension

A broad coalition of 300 to 400 telehealth stakeholders are uniting to draft a letter pressing the Senate to take up bipartisan telehealth legislation that extends numerous Medicare telehealth flexibilities when they return from August recess, Inside Telehealth has learned. A key lobbyist also says the stakeholders plan to ask lawmakers to extend other pandemic-related flexibilities not included in the House-passed version of the Advancing Telehealth Beyond COVID-19 Act (HR 4040), like coverage of telehealth services pre-deductible for people...
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InsideHealthPolicy.com
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Biden Holds ‘Day Of Action’ To Tout Efforts To Protect Abortion Access

The White House on Friday (Aug. 26) reminded governors of their obligations to follow federal emergency medical guidance and asked them to use Medicaid to pilot cross-state abortion programs. The White House is touting Aug. 26 as a day of action on reproductive health care, which senior White House officials announced Thursday evening, and it follows conflicting federal court rulings in Texas and Idaho on the Biden administration efforts to ensure access to abortions during medical emergencies. Biden administration officials...
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InsideHealthPolicy.com
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