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Accelerated Approval Process Is Not Without Risk: Placing Recent FDA Action in Context
On February 23, the Food and Drug Administration (FDA) withdrew approval of Pepaxto (melphalan flufenamide), a drug that it had previously granted accelerated approval for treatment of multiple myeloma. The decision came after a post-marketing, confirmatory study of Pepaxto failed to confirm the drug’s clinical benefit, and FDA determined that available evidence demonstrated that Pepaxto…
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Hackers Claim Cyberattack on American Clinical Solutions Resulted in Data Breach Impacting 400k Medical Records
Recently, reports began to emerge about a possible American Clinical Solutions, LLC (“ACS”) data breach. While ACS has not yet acknowledged a cyberattack or a subsequent data breach, hackers claim to have obtained consumers’ sensitive information, which includes their names, Social Security numbers, dates of birth, genders, patient ID numbers, laboratory results, policy numbers, insurance…
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Gasket/Packing Manufacturer Prevails after Jury Trial
Court: United States District Court for the District of Massachusetts Decedent Arnold L. Pritt was diagnosed with singular mesothelioma, epithelioid type in September 2019. He alleged he was exposed to asbestos during his service in the U.S. Navy and as a civilian electrician….By: Goldberg Segalla
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DOJ Seeks 10-Year Prison Sentences in First Consumer Product Safety Conviction
This month, the government is asking for a pair of 10-year prison sentences for two Gree USA Inc. executives convicted of failing to report defective humidifiers. This comes after the two were found guilty of conspiracy to defraud the US Consumer Product Safety Commission (“CPSC”) and of failing to satisfy the reporting requirements of the…
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Middle East Crisis: Deadly Strike in Rafah Did Not Cross Biden’s Red Line, Officials Say
President Biden has threatened to cut off the supply of some weapons if Israel mounts a major offensive in Rafah. “We haven’t seen that,” a White House spokesman said.
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Georgia’s Ruling Party Secures a Contentious Law on Foreign Influence
The Parliament, controlled by the Georgian Dream party, overrode a presidential veto of a bill critics say could undermine the country’s efforts to join the European Union.
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Calls Mount to Let Ukraine Strike Russia With Western Weapons
The U.S. and other allies have banned Ukraine from firing Western weapons into Russia. Kyiv says that has handcuffed its ability to prevent cross-border attacks.
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Why Lawmakers Are Brawling and People Are Protesting in Taiwan
Supporters of President Lai Ching-te are protesting legislative amendments introduced by the opposition that would limit his authority.
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War-Weary Iraqis Feel for Gaza, but Fear Spread of the Conflict
Iraqis want to help Palestinians but say they are still recovering from their own wars and fear playing host to a proxy fight between Iran and the United States.
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Want to Succeed as an Artist? We’ve Got a Coach For You.
With a rising number of artists vying for a limited number of galleries and grants, arts professionals are pivoting to careers as coaches. But can they help people profit from their talents?
