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Home » Topics » Regulatory

Regulatory
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Breast implants

FDA reports 59 deaths across the globe due to lymphoma associated with breast implants

Aug. 8, 2022
By Mark McCarty
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.
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Regulatory actions for Aug. 8, 2022

Aug. 8, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Microport Navibot.
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US Rx price negotiations a step away from law

Aug. 8, 2022
By Mari Serebrov
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.
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Regulatory actions for Aug. 8, 2022

Aug. 8, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abivax, Acadia, Astrazeneca, JCR, Marker, Neurocrine, Sosei.
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Lungs wireframe illustration

FDA clears Adherium’s Hailie sensor for GSK’s Ellipta inhaler

Aug. 5, 2022
By Tamra Sami
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).
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Janet Woodcock headshot

FDA’s Woodcock: Potential hires watching as user fee legislation languishes

Aug. 5, 2022
By Mark McCarty
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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Regulatory actions for Aug. 5, 2022

Aug. 5, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Genbody, Vieworks, Wision.
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Vials of monkeypox vaccine

HHS’s public health emergency declaration on monkeypox prompts preparations

Aug. 5, 2022
By Lee Landenberger and Jennifer Boggs
Now that the U.S. Department of Health and Human Services (HHS) has declared monkeypox a public health emergency, nearly two weeks after a similar declaration from the World Health Organization, the way is cleared for a coordinated response and emergency use authorizations to address supply challenges that could limit the availability of currently approved vaccines. It also has several companies ready to leap into the fray if their preclinical studies show a path to approval. HHS said it just shipped more than 602,000 doses of the Jynneos vaccine to states and jurisdictions, an increase of 266,000 in the past week.
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Regulatory actions for Aug. 5, 2022

Aug. 5, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ascletis, Astrazeneca, Biocryst, Immunabs, Janssen, Jubilant, Panbela, Syros, Vaxcyte, Xortx.
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Good news for Amylyx as it prepares for adcom redux

Aug. 4, 2022
By Mari Serebrov
Amylyx Pharmaceuticals Inc. got good news when the Institute for Clinical and Economic Review posted a revised evidence report Aug. 4 that assessed the comparative clinical effectiveness and value of the company’s AMX-0035 and Mitsubishi Tanabe Pharma America Inc.’s Radicava (edaravone) in treating amyotrophic lateral sclerosis.
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