Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Circa Scientific, KSL Diagnostics, SQI Diagnostics.
Vena Medical Inc. received Health Canada approval for a device that combines two neurovascular catheters that typically work separately to remove clots from the brains of people who have suffered stroke.
The FDA continues its tight surveillance of rapid antigen tests for the COVID-19 pandemic and has issued three safety communications advising against the use of these tests thus far in the month of March. In each instance, the test is made by the manufacturer of name, but was not authorized in the U.S., making these misbranded products despite their legal use in other nations.
The U.S. FDA does not have legal authority to impose recalls on most regulated products, making the March 3 final guidance for voluntary recalls a key policy declaration for industry. The guidance recommends that recalling firms make extensive use of electronic communication to announce a recall, but the referenced FDA guidance for electronic communications was finalized in 2006 and makes no reference to social media as an electronic conduit for recall information.
A Purdue Pharma LP bankruptcy settlement is back on track now that the Sackler family has agreed to pay at least $5.5 billion, and up to $6 billion, for the role they played in the nationwide opioid epidemic.
There’s nothing like beginning-of-the-year price increases to turn up the heat on the prescription drug pricing debate in the U.S. This year is no exception. Citing a mean price increase of 5.1% on brand drugs in the first 25 days of 2022, 13 Democratic lawmakers, led by Sen. Elizabeth Warren (D-Mass.), wrote this week to Steven Ubl, president and CEO of the Pharmaceutical Research and Manufacturers of America, demanding an explanation for those hikes.
Amgen Inc.’s pioneering lung cancer drug, Lumykras (sotorasib), is set to become available to NHS patients in England, after cost-effectiveness body NICE recommended financing from the Cancer Drugs Fund (CDF) in final draft guidance.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Carsgen, Cidara, I-Mab, Inhibrx, Priothera, Sorrento, TG, Tonix.
LONDON – The European Commission (EC) has put forward proposals for a Data Act that is intended to both give users greater rights over their own data and allow greater third-party access. The Act sets out who can use and access data generated in the EU across all sectors of the economy. It is pitched by the EC as opening the doors to an under-used resource that will in turn promote research and innovation and create new markets in information services.