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Home » Topics » Regulatory

Regulatory
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Acquisitions fodder of US insider trading allegations

July 25, 2022
Insider trading appears to be the U.S. SEC violation du jour. The agency filed insider trading charges against 10 individuals July 25, including a former FBI trainee and his friend who made about $82,000 and $1.3 million, respectively, from illegally trading ahead of the February 2021 announcement of Merck & Co. Inc.’s $1.85 billion tender offer to acquire Pandion Therapeutics Inc.
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US drug codes due for an update

July 25, 2022
By Mari Serebrov
It was bound to happen someday. With more and more prescription drugs coming to the U.S. market, the FDA is running out of unique combinations for the 10-digit national drug code given to each product.
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Regulatory actions for July 25, 2022

July 25, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acufocus.
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Regulatory actions for July 25, 2022

July 25, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Acticor, Alnylam, Ascentage, Astellas, Aurinia, Bavarian Nordic, Bristol Myers Squibb, Genentech, Genfleet, Gilead, Janssen, Moderna, Rhythm, Roche, Seagen, Zelira.
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Minuteful Kidney test kit box

‘If you can text, you can test’ for kidney disease

July 22, 2022
By Annette Boyle
The U.S. FDA handed good news to Healthy IO Ltd. (Healthy.io) with 510(k) clearance for its smartphone-based Minuteful Kidney test, making kidney function testing – from sample to result – possible at home. The app calculates the albumin-to-creatinine ratio (ACR), a key indicator of kidney disease. By enabling people to complete the test using their phones, the company says it has increased the rate of testing in high-risk patients by 50%.
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Illustration of mitochondrion inside the cancer cell

Alpheus Medical wins orphan drug and fast track designations to fight deadliest form of brain cancer

July 22, 2022
By David Godkin
The U.S. FDA has granted Alpheus Medical Inc. orphan drug and fast track designations for a therapeutic platform that could improve outcomes for patients suffering from recurrent glioblastoma (GBM), the most common primary brain cancer and among the hardest to treat.
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Map of Europe

Russia looks to expand its influence through health care

July 22, 2022
By Mari Serebrov
Citing “the current political conditions,” Russian Minister of Health Mikhail Murashko laid out ways for Russia to strengthen its international role in the health care sector, including the development of innovative radiopharmaceuticals. Other promising opportunities involve the improvement of drug provision and an increase in the number of foreign students in Russian medical universities, Murashko said at a July 19 meeting with medical, educational and scientific institutions in Russia.
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Regulatory actions for July 22, 2022

July 22, 2022
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Irthythm, Verily.
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Amvuttra

Alnylam’s Amvuttra rare disease drug among positive recommendations from Europe’s CHMP

July 22, 2022
By Richard Staines
Alnylam Pharmaceuticals Inc.’s Amvuttra (vutrisiran), a treatment for the rare disease hereditary transthyretin-mediated amyloidosis, was among medicines recommended for approval by regulators from Europe’s Committee for Medicinal Products for Human Use (CHMP) in a busy sitting.
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Regulatory actions for July 22, 2022

July 22, 2022
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Incannex, Junshi, Karyopharm, NLS, Obsidian, Olema, Pliant, Recursion, Sandoz, Sangamo.
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