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Regulatory
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Limb exam

Avidity searches for cause of SAE as FDA puts partial hold on dystrophy study

Sep. 27, 2022
By Lee Landenberger
A serious adverse event (SAE) in one participant has led the U.S. FDA to place a partial clinical hold on Avidity Biosciences Inc.’s lead program. The action is centered on the phase I/II Marina study of AOC-1001, an antibody oligonucleotide conjugate for treating myotonic dystrophy type 1, the most common form of muscular dystrophy in adults.
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US FDA proposes harmonizing rules for clinical trials

Sep. 27, 2022
By Mari Serebrov
As part of its obligations under the 21st Century Cures Act, the U.S. FDA is proposing two new rules to harmonize sections of its regulations on human subject protection and institutional review boards with the revised Common Rule, which provides for the protection of human subjects in federally funded research.
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Biogen to pay $900M to end whistleblower suit

Sep. 27, 2022
By Mari Serebrov
While it continues to deny all kickback allegations raised in a whistleblower suit filed seven years ago, Biogen Inc. agreed Sept. 26 to pay $900 million to resolve claims that it paid doctors in the U.S. to prescribe its multiple sclerosis drugs from 2009 through March 2014.
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FDA gives thumbs up to Santen, UBE’s Omlonti for reducing intraocular pressure

Sep. 27, 2022
By Tamra Sami
The U.S. FDA approved Santen Pharmaceutical Co. Ltd.’s  and UBE Industries Ltd.’s Omlonti (omidenepag isopropyl) ophthalmic solution for reducing elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension. It is the second FDA-approved product from Japan-based Santen in the last 15 months for patients in the U.S. with vision conditions.
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Magnifying glass atop paperwork

Chinese US-listed pharma, med-tech companies gear up for PCAOB inspections

Sep. 27, 2022
By Tamra Sami
Inspectors from the U.S. Public Company Accounting Oversight Board (PCAOB) have reportedly arrived in Hong Kong to inspect audit records for the Chinese companies listed by the U.S. SEC as being noncompliant with U.S. accounting standards.
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Digital 3-D illustration of Japan's flag, light effects

Japan approves Daiichi Sankyo’s Ezharmia for refractory T-cell leukemia, lymphoma

Sep. 27, 2022
By Tamra Sami
Japan’s Ministry of Health, Labor and Welfare approved Daiichi Sankyo Co. Ltd.’s Ezharmia (valemetostat tosilate), the first dual inhibitor of histone methyltransferases EZH1 and EZH2 for the treatment of patients with relapsed or refractory adult T-cell leukemia and lymphoma. It’s Daiichi Sankyo’s fifth new oncology medicine approved in Japan in the past three years.
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Regulatory actions for Sept. 27, 2022

Sep. 27, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aqualung, Atea, Catalym, Everest, Pfizer, Y-mabs.
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Handshake in office setting

Senate, House committees work to avert FDA shutdown with user fee handshake

Sep. 26, 2022
By Mark McCarty
Legislation to reauthorize a number of U.S. FDA user fee programs has once again languished until the 11th hour, but the House and Senate committees of jurisdiction have apparently come to terms over the matter. However, the parties to this deal are characterizing it as a “clean” bill, which suggests that FDA regulation of lab-developed tests (LDTs) and a center of drug manufacturing of excellence will have to wait for another day or – because of the upcoming mid-term elections – most likely another year.
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Clearpoint

Clearpoint’s Swedish partner snares 510(k) for laser interstitial therapy for brain lesions

Sep. 26, 2022
By Mark McCarty
Clearpoint Neuro Inc. said Clinical Laserthermia Systems AB (CLS), snared a 510(k) from the FDA for a laser interstitial therapy system that will be marketed in the U.S. as part of the Clearpoint Prism Neuro system. This product package adds to a growing Clearpoint footprint in the neurological disorders space, adding to an inventory that already consists of targeted drug delivery and deep brain stimulation systems.
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US FDA lays out safeguards for including kids in trials

Sep. 26, 2022
By Mari Serebrov
In recent years, ethicists have executed a 180-degree shift on including children in clinical trials testing drugs, biologics and medical devices, moving from the idea that it was unethical to include youngsters in trials to an understanding that such inclusion may be the best way of protecting them.
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