The U.S. FDA has approved Daiichi Sankyo Co. Ltd. and Astrazeneca plc’s Enhertu (fam-trastuzumab deruxtecan) as the first HER2-directed therapy for patients with HER2-low metastatic breast cancer.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Avenda, Bodyport, Bot Image, Cerevasc, Imspex Diagnostics, Medalliance, Neuroone.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bayer, Daiichi, Immvira, Myovant, Orion, Scisparc, Tracon.
When medical device manufacturers think of U.S. federal government enforcement, the Sarbanes-Oxley Act (SOX) of 2002 might not be the first element of the statute to come to mind. However, the Securities and Exchange Commission (SEC) used SOX to snare Suralign Holdings Inc. for pushing orders to customers ahead of schedule to draw the related revenue forward, an allegation that led to restitutions and penalties amounting to nearly $3 million.
The U.S. FDA has updated its data on the number of fatalities across globe associated with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), which has now reach 59 fatalities. That number is up from 33 reported in July 2019 but is also a number the agency continues to assert may be a significant undercount.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Microport Navibot.
Within a few weeks, government price negotiations for some prescription drugs, as well as limits on annual price increases, could be the law of the land in the U.S. With the Senate passing a slimmed-down version of H.R. 5376 through reconciliation Aug. 7, the House is expected to make a brief return Friday from its August recess to vote on the changes and conference the differences between its bill and the Senate version. Then it’s on to the president’s desk for the signature that will enact the package of health care, tax and climate provisions.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Acadia, Astrazeneca, JCR, Marker, Neurocrine, Sosei.
The FDA granted Adherium Ltd. 510(k) clearance for its next-generation Hailie sensor that connects with Glaxosmithkline plc’s Ellipta inhaler to enable monitoring of medication use for asthma and chronic obstructive pulmonary disorder (COPD).
The U.S. Senate and House of Representatives have not yet come to terms on FDA user fee legislation, a quinquennial source of melodrama that leaves the agency in an awkward position with current employees. However, FDA principal deputy commissioner Janet Woodcock said recently that prospective employees are also watching how Congress handles its business, adding that some of these pending hires may take jobs elsewhere rather than wait on Congress to send a user fee bill to the White House.
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