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CRISPR Regulatory Updates
On December 15, 2023, Vertex announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has adopted a positive opinion for the conditional approval of CASGEVY (exagamglogene autotemcel [exa-cel]), a CRISPR/Cas9 gene-edited therapy, for the treatment of severe sickle cell disease (SCD) and transfusion-dependent beta thalassemia (TDT)….By: Goodwin
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Updates on Patent Challenges by Biosimilar Manufacturers at the PTAB
In the last month, there has been a flurry of activity at the PTAB related to challenges from biosimilar manufacturers related to ustekinumab, aflibercept, and eculizumab patents….By: Goodwin
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ESO Solutions Data Breach Update: ESO Solutions Announces Data Breach
Earlier this week, ESO Solutions filed a notice of data breach with the Attorney General of Maine in the wake of what appears to have been a massive ransomware attack. The ESO data breach letter made it clear that the incident affected patient data at various hospitals and healthcare systems; however, no healthcare facilities were…
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Talc Defendants’ Motion to Dismiss Punitive Damages Claim Granted; Motion to Dismiss Civil Conspiracy Claim Denied
U.S. District Court for the Eastern District of Louisiana – In this asbestos action, plaintiff Michael Simoneaux initially filed suit against his former employers for alleged asbestos exposure. He later amended his complaint to include Mennen and Johnson & Johnson (hereinafter, “Talc Defendants”), asserting that from the 1960s until 2000 he consistently used Mennen Baby…
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HealthEC Files Notice of Data Breach Impacting Information Provided to MD Valuecare, LLC
On December 22, 2023, HealthEC LLC (“HEC”) filed a notice of data breach with the Attorney General of Maine after discovering that an unauthorized party was able to gain access to the company’s IT network. In this notice, HEC explains that the incident resulted in an unauthorized party being able to access MD Valuecare customers’…
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LoanCare, LLC Confirms Recent Data Breach Affecting 1.3m Consumers
On December 20, 2023, LoanCare, LLC filed a notice of data breach with the Attorney General of Maine after discovering that an unauthorized party had accessed the computer system of its parent company, Fidelity National Financial, Inc. In this notice, LoanCare explains that the incident resulted in an unauthorized party being able to access consumers’…
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New Animal Feed Proposal Introduced in US House
On December 7, U.S. Representative Greg Pence (R-IN) introduced the Innovative Feed Enhancement and Economic Development Act of 2023 (the Innovative FEED Act). Sen. Roger Marshall (R-KS) introduced the Senate version of the bill earlier this year….By: Perkins Coie
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Israel-Hamas War: Top Israeli Official Threatens Stronger Action on Lebanon Border
“The stopwatch for a diplomatic solution is running out,” said the official, Benny Gantz. The warning comes after weeks of Hezbollah rocket fire directed at northern Israel.
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A General’s Account of Oct. 7 Battle for Be’eri Stirs Debate in Israel
The commander told The New York Times about how he had authorized Israeli tank fire on a house where hostages were being held by Hamas fighters.
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Indian Envoy Hails Ties With Russia, Despite Western Pressure
India’s foreign minister is on a five-day diplomatic trip to Moscow to reinforce economic and defense ties, though some strains in the countries’ relationship are showing.
