The FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee recently discussed the increased risk of Andexxa clotting-related deaths and Andexxa blood clots seen in the ANNEXA-I trial done for Andexxa, compared with a standard of care reversal agent. This Andexxa Advisory Committee … More
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Recent Articles
Treatment of Malignant Pleural Mesothelioma: American Society of Clinical Oncology Clinical Practice Guideline
Introduction The purpose of this guideline is to provide recommendations for the management of patients with malignant pleural mesothelioma (MPM), an aggressive tumor with a poor prognosis. In the United States, about 3,000 new cases are diagnosed each year. The median overall survival of patients … More
Depo-Provera Meningioma Brain Tumors Drug Injury Lawsuits
Because the current drug label for Depo-Provera Contraceptive Injection (version “Revised: 7/2024”, accessed 10/16/24) does not include any warning about an increased risk of intracranial meningioma, we are investigating possible Depo-Provera meningioma brain tumors drug injury lawsuits seeking … More
Immunotherapy for Treatment of Pleural Mesothelioma: Current and Emerging Therapeutic Strategies
Pleural mesothelioma is a rare malignancy associated with asbestos exposure and very poor prognosis, with a 5-year overall survival of 12%. Outcomes may vary according to stage at time of diagnosis and histologic subtype. Most recently, clinical trials utilizing dual checkpoint inhibitor regimens … More
No Federal Preemption for Fosamax MDL Femur Fracture Lawsuits: September 2024 Update
The United States Court of Appeals for the Third Circuit recently issued this opinion, In re: Fosamax (alendronate sodium) Products Liability Litigation, No. 22-3412, (3d Cir. Sept. 20, 2024), ruling that there is no federal preemption for more than 500 Fosamax MDL femur fracture lawsuits that had … More
FDA Approves Pembrolizumab Plus Chemo for Unresectable Advanced or Metastatic Malignant Pleural Mesothelioma
The FDA has approved [ Keytruda (pembrolizumab) ] plus pemetrexed and platinum chemotherapy in the frontline treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. Data from the phase 2/3 KEYNOTE-483 study (NCT02784171) showed that [ Keytruda … More