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Regulatory
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Chinese flag on flagpole

Xzing’s disposable electronic colonoscope greenlighted by China’s NMPA

June 3, 2022
By Doris Yu
Shenzhen Xzing Technology Co. Ltd. received marketing approval from China’s NMPA for its Endofresh disposable electronic colonoscope. The disposable colonoscope provides images with 1920 x 1080 pixels, which helps with diagnosis. It is equipped with auxiliary water and a lens-washing function to make sure of clear vision throughout endoscopy. It also allows users to insert endoscopic accessories at any bending angle no more than 210 degrees.
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Gavel and scales

US federal government ramping up enforcement on life science companies

June 3, 2022
By Mark McCarty
Drug and device makers are necessarily wary of any activities that could lead to prosecution under the False Claims Act (FCA), but seemingly innocuous activities are now fair game for federal prosecutors. The latest example is the FCA prosecution of Caris Life Sciences for filing claims for cancer tests outside the 14-day post-discharge window, and Mark Gardner, directing attorney at Gardner Law of Stillwater, Minn., told BioWorld that device makers should be on the alert because it appears that federal authorities are ramping up enforcement.
Read More

FDA reviewers raise myocarditis concerns ahead of Novavax adcom

June 3, 2022
Shares of Novavax Inc. dropped 19% after briefing documents released ahead of the U.S. FDA’s June 7 advisory committee raised concerns about risks of myocarditis associated with COVID-19 vaccine NVX-CoV2373, though reviewers also noted the vaccine could offer protection against the omicron variant. The stock (NASDAQ:NVAX) closed June 3 at $44.76, down $11.21.
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Regulatory actions for June 3, 2022

June 3, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Accutar, Aeglea, Algotx, Evofem, Gamida, Iaso, Innovent, Myovant, Opiant, PDS, Pfizer, Takeda.
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Toy bulldozer moving FDA letter blocks

US federal government ramping up enforcement on life science companies

June 2, 2022
By Mark McCarty
Drug and device makers are necessarily wary of any activities that could lead to prosecution under the False Claims Act (FCA), but seemingly innocuous activities are now fair game for federal prosecutors. The latest example is the FCA prosecution of Caris Life Sciences for filing claims for cancer tests outside the 14-day post-discharge window, and Mark Gardner, directing attorney at Gardner Law of Stillwater, Minn., told BioWorld that device makers should be on the alert because it appears that federal authorities are ramping up enforcement.
Read More

BLA delay: Aeglea’s pegzilarginase hit with RTF letter

June 2, 2022
By Jennifer Boggs
Shares of Aeglea Biotherapeutics Inc. tumbled 51% June 2 on news that it received a refusal to file (RTF) letter from the U.S. FDA regarding the BLA for pegzilarginase for the treatment of arginase 1 deficiency, with the agency requesting additional efficacy data.
Read More
Capsule with Italian flag

Competition authorities find pricing of rare disease drug ‘excessive’

June 2, 2022
By Mari Serebrov
Following an investigation into Leadiant Group’s pricing of a rare disease drug, the Italian Competition Authority fined the privately held company about €3.5 million (US$3.76 million) May 31 for charging the Italian National Health Service excessive prices since 2017 for Chenodeoxycholic Acid Leadiant.
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Investigation into questionable investments prompts executive re-shuffle at China’s Cstone

June 2, 2022
By Tamra Sami
Suzhou, China-based Cstone Pharmaceuticals Co. Ltd. has begun trading again on the Hong Kong exchange (HKEX:02616) after trading was halted on April 1 following investigations over questionable investments during the company’s year-end audit for 2021.
Read More

Regulatory actions for June 2, 2022

June 2, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Cardio Flow, Lumiradx, Net Health.
Read More

Regulatory actions for June 2, 2022

June 2, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Apellis, Codagenix, Eagle, Foresee, Hutchmed, Kashiv, Kymera, Mezzion, Midatech, Neuronascent, Roche, Sanofi, Swedish Orphan, Teon, TG, UCB, VBI.
Read More
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