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Regulatory
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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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Drug capsule and dollar sign

U.S. price controls could affect devices, diagnostics as well as drugs

Aug. 4, 2022
By Mari Serebrov
No one denies that fewer new drugs will be a consequence of the Medicare drug pricing provisions the Democrats are trying to push through the U.S. Congress ahead of the midterm election campaign season. Less attention has been paid to the negative impact on drug-device combinations and new diagnostics that accompany innovative treatments.
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Regulatory actions for Aug. 4, 2022

Aug. 4, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acclarent, Endologix, Glaukos, Pulse Biosciences.
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Regulatory actions for Aug. 4, 2022

Aug. 4, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amylyx, Anheart, Ascletis, Avenge, Biontech, Coherus, Jiangsu Recbio, Lynk, Maia, Marius, Mediwound, Olix, Pfizer, Profoundbio, Regenxbio, Renovion, Sinovac, Sumitomo.
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