Objectives Occupational asbestos exposure is causally linked to mesothelioma. However, whether exposure to only chrysotile asbestos is associated with mesothelioma risk, and the heterogeneity in risk by different fibre types/lengths remains unclear. We investigated whether mesothelioma risk differs among workers exposed to only chrysotile … [Read more...]
Beovu Legal Cases: Compensation for Eye Problems from Beovu Use
Our law firm is investigating possible Beovu lawsuits for patients who have been diagnosed with vision loss, blindness, or other serious eye problems which are Beovu side effects. Such drug injury Beovu legal cases might involve one or more of the following Beovu eye-related side effects: Vision LossBlindnessOcclusive Retinal VasculitisRetinal … [Read more...]
Global Picato Recall Due to Picato Skin Cancer Risk Findings Update
There have been several Picato recall announcements around the world during the past year. All of these are due to Picato skin cancer risk findings by drug safety regulators. As reported in this October 28, 2020 item, "Denmark’s LEO Pharma initiates Picato phase-out", published on thepharmaletter.com site: Following safety warnings on Picato … [Read more...]
Stelara-associated Cardiovascular Events: Emerging Drug Safety Issue
There is a new drug safety issue for Stelara. This time it is that Stelara-associated cardiovascular events were reported in a French medical study which, in turn, has resulted in some concern about the safety of Stelara. The Stelara French study results were outlined in this medical journal article, "Association Between Early Severe … [Read more...]
Black Box Warning Label Change for Breast Implants Finalized by the FDA
Since our previous article, “New BIA-ALCL Cases Identified in Updated FDA Report“, the FDA has finalized labeling guidance for breast implant manufacturers. The FDA label change is now requiring a black box label warning for the breast implant devices. In recent years, many textured breast implants have been linked to BIA-ALCL (breast … [Read more...]
Biomarker candidates could aid in earlier diagnosis of mesothelioma
Mesothelioma is a deadly cancer mainly caused by exposure to asbestos fibers. Unfortunately, mesothelioma is generally diagnosed at an already advanced stage and none of the therapeutic strategies tried so far is able to eradicate the disease. So new biomarkers that could help to identify the disease at an earlier stage are urgently … [Read more...]
Ocaliva Drug Label Warnings vis-à-vis FDA Ocaliva Safety Signal Investigation
In our last article, we reported on the current FDA investigation of an Ocaliva safety signal which, although it began in May 2020, only became public knowledge in October. The best we can tell, it is a possible Ocaliva liver toxicity issue that is the subject of this Ocaliva FDA investigation. Now we have some additional information about some … [Read more...]
A multicentre randomised phase III trial comparing pembrolizumab vs single-agent chemotherapy for advanced pre-treated malignant pleural mesothelioma: the European Thoracic Oncology Platform (ETOP 9-15) PROMISE-meso trial
Background: Malignant pleural mesothelioma (MPM) is an aggressive malignancy characterized by limited treatment options and a poor prognosis. At relapse after platinum-based chemotherapy, single-agent chemotherapy is commonly used and single-arm trials of immune-checkpoint inhibitors have demonstrated encouraging activity. Patients and … [Read more...]
Current Ocaliva Liver Safety FDA Evaluation Started Back in May 2020
In October 2020 we first learned about a "new" drug safety issue for Ocaliva -- although it apparently has been on the FDA's radar since at least May 2020. It seems a possible Ocaliva liver-related side effects risk has attracted scrutiny, and there is an Ocaliva liver safety FDA evaluation underway. It was this October 9, 2020, Endpoints News … [Read more...]
FDA Approves Drug Combination for Treating Mesothelioma
[On October 02, 2020], the U.S. Food and Drug Administration approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the first-line treatment of adults with malignant pleural mesothelioma that cannot be removed by surgery. This is the first drug regimen approved for mesothelioma in 16 years and the second FDA-approved systemic … [Read more...]
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