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Teva’s Denosumab Biosimilar Candidate is Accepted for Review by FDA and EMA
On October 8, 2024, Teva Pharmaceutical Industries Ltd. announced that the United States Food and Drug Administration (FDA) has accepted, and the European Medicines Agency (EMA) has validated, applications for TVB-009P, a biosimilar candidate to Amgen’s PROLIA® (denosumab) that treats osteoporosis……By: Goodwin
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Accord BioPharma’s Stelara® Biosimilar Imuldosa™ Approved by FDA
On October 10, 2024, the FDA approved Accord BioPharma’s Imuldosa™ (ustekinumab-srlf), the fifth biosimilar of Janssen / Johnson & Johnson’s Stelara® (ustekinumab). Imuldosa™ was developed by Dong-A ST in collaboration with Meij Seika Pharma, and Accord is responsible for commercialization in the U.S….By: Venable LLP
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Worker’s Comp Versus Personal Injury in California
According to the United States Bureau of Labor Statistics, a reported 419,000 private-sector employees in California sustained workplace injuries and illnesses in 2022. Workplace incidents in the state claimed 508 employees’ lives in 2022 in the state….By: Maison Law
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Novacure’s Wearable Lung Cancer Treatment Device, Optune Lua, Receives FDA Approval
The FDA has granted approval for Novocure‘s wearable medical device, Optune Lua, designed to treat advanced non-small cell lung cancer (NSCLC). The device utilizes portable transducer arrays placed on the skin to deliver alternating electrical fields, termed Tumor Treating Fields (TTFs), thereby disrupting malignant cell division while leaving healthy cells largely unaffected….By: Knobbe Martens
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NY Court Grants Defendant’s Motion for Summary Judgment Following Improper Service in Illinois Action
Jurisdiction: Supreme Court of New York, New York County – In a New York City asbestos action, defendant Tishman Liquidating Corporation moved for summary judgment to dismiss plaintiff’s complaint, arguing the plaintiff’s decedent’s deposition testimony could not be used against it at trial….By: Goldberg Segalla
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Data Breach at Birth Choice of San Marcos Caused by Cyberattack at National Diagnostic Imaging
On October 16, 2024, Birth Choice of San Marcos (“BirthChoice”) filed a notice of data breach with the Attorney General of California after discovering that a vendor used by BirthChoice, National Diagnostic Imaging (“NDI”), experienced a cyberattack. In this notice, BirthChoice explains that the incident resulted in an unauthorized party being able to access consumers’…
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CPSC Commissioners Abstain From Retracting Infant Sleep Product Statements
In a disappointing, yet somewhat unsurprising, turn of events, the Consumer Product Safety Commission (CPSC) has refused to retract Commissioner Richard Trumka’s unilateral statements earlier this year encouraging retailers to stop selling weighted infant sleep products. On August 30, 2024, following public outcry over Commissioner Trumka’s statements, CPSC Commissioners Peter A. Feldman and Douglas Dziak…
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Autopsy Shows Hamas Leader, Yahya Sinwar, Was Killed by a Gunshot to the Head
Mr. Sinwar had also been hit in the arm during a firefight earlier with Israeli soldiers, according to the Israeli doctor who oversaw the autopsy. Hamas confirmed its leader’s death but said his “banner will not fall.”
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Yahya Sinwar’s Death Could Shake But Not Topple Hamas, Experts Say
Analysts call the killing of several Hamas leaders, including Yahya Sinwar, a deep blow to the Palestinian militant group, but expect it to keep fighting.
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The Gisele Pelicot Rape Trial Hits Painfully Close to Home in This French Town
The town of Mazan, where Gisèle Pelicot was drugged and raped by her husband and strangers, has been shaken by the revelations. “It feels a bit like it’s in our family,” one resident said.
