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Denosumab Biosimilar Updates
Celltrion Submits Denosumab BLA to FDA: On November 30, 2023, it was reported that Celltrion had completed submission of its application to the FDA for CT-P41, its denosumab biosimilar of Amgen’s PROLIA and XGEVA….By: Goodwin
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A GDPR for AI? Political Agreement Reached on the EU AI Act
Political agreement was reached on 9 December in the negotiations on the EU AI Act, arguably the world’s most comprehensive and ambitious AI law to date. Some further steps must take place, including confirmation by the EU Parliament and Council, before the text is adopted and becomes law, but this ambitious legislation is expected to apply throughout…
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Regional Family Medicine Confirms Data Breach Resulting from Recent IT Outage
On December 12, 2023, Regional Family Medicine filed a notice of data breach with the Attorney General of Maine after discovering that what initially appeared to be an IT outage was really a cyberattack. In this notice, Regional Family explains that the incident resulted in an unauthorized party being able to access consumers’ sensitive information,…
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Harrisburg Medical Center Experiences Data Breach Affecting Over 147k Patients
On December 12, 2023, Southern Illinois Healthcare – Harrisburg Medical Center (“SIH HMC”) filed a notice of data breach with the Attorney General of Maine after discovering that an unknown and unauthorized party was able to access its computer network. In this notice, HMC explains that the incident resulted in an unauthorized party being able…
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MoCRA: What’s on the horizon for PFAS?
This article is one of a series of posts diving into each aspect of The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) as the industry awaits MoCRA’s full implementation. This installment focuses on MoCRA’s approach to the regulation of perfluoroalkyl and polyfluoroalkyl substances (PFAS) in cosmetic products….By: Husch Blackwell LLP
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FDA Warning Letter Declares Delta-8 and CBD Gummies ‘Adulterated Foods’
On Dec. 6, 2023, the U.S. Food and Drug Administration (FDA) sent a warning letter to the owners of online hemp, tetrahydrocannabinol (THC) and cannabidiol (CBD) retailer Hemp-xr.com for introducing adulterated foods into interstate commerce. FDA took issue with certain cookies, edibles, gummies and honey containing delta-8 THC and CBD because they “bear or contain…
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Israel-Hamas War: After Meeting Biden, Hostage Families Express Confidence in U.S. Efforts
President Biden’s meeting with the families lasted more than an hour. He had previously spoken with them by video call days after the Oct. 7 attack.
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Ukraine Faces Critical Tests as It Duels With Russia for Stamina
With Western support for Kyiv softening and Congress holding up urgently needed aid, Vladimir Putin’s bet on outlasting Ukraine and its allies is looking stronger.
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Germany Reaches a Budget With Promises on Ukraine
The government avoided extra borrowing for 2024, but must make cuts in programs to address climate change.
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Israel’s Netanyahu, Sparring With Biden on Gaza, Faces Risk and Reward
Israel’s prime minister said he disagreed with President Biden about what should happen in Gaza after the war, and analysts say he might try to use the rift to shore up domestic support.
