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Home » Topics » Regulatory

Regulatory
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Cresilon employee works the line at the company’s manufacturing plant

FDA review gels into clearance for plant-based, blood stopping technology

July 13, 2023
By David Godkin
Cresilon Inc. obtained U.S. FDA clearance for a hemostatic gel that staunches the flow of blood from minor external wounds. The Cresilon hemostatic gel (CHG) is the first technology to blend polymers from the algae plant to instantaneously create a mechanical barrier against bleeding.
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Regulatory actions for July 13, 2023

July 13, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aridis, Astrazeneca, Beigene, Daiichi, Junshi, Takeda, Therapeutic Solutions.
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Antibiotic resistant bacteria inside a biofilm

Antimicrobial resistance has administrative resistance too

July 12, 2023
By Lee Landenberger
The counterintuitive side of preventing a health crisis prompted by antimicrobial resistance showed itself at a July 11 U.S. Senate hearing, with witnesses saying that antibiotics exist to treat current infections but they often don’t have staying power in the market.
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Mosquito and dengue vaccine

Takeda withdraws U.S. BLA for dengue fever vaccine Qdenga

July 12, 2023
By Tamra Sami
Takeda Pharmaceutical Co. Ltd. has voluntarily withdrawn its U.S. BLA for its dengue fever vaccine, Qdenga (TAK-003), following discussions with the FDA centered on “aspects of data collection, which cannot be addressed within the current BLA review cycle,” the company said in a statement. News of the withdrawal comes more than a month after the May 23 Qdenga PDUFA date. The future plan for Qdenga in the U.S. will be further evaluated given the need for travelers and those living in dengue-endemic areas of the U.S., such as Puerto Rico.
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Regulatory actions for July 12, 2023

July 12, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Allosource, Boston Scientific, Invictus Medical, Teijin Medical.
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European Commission headquarters

EC fines Illumina €432M for closing Grail deal without its approval

July 12, 2023
By Shani Alexander
The European Commission (EC) fined Illumina Inc. a record €432 million (US$476 million) for closing the acquisition of Grail Inc. before receiving regulatory approval. It is the highest fine ever imposed on a company by the EC for completing a deal without its consent. Grail was fined €1,000. The companies were found to be in breach of EU merger control rules.
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Regulatory actions for July 12, 2023

July 12, 2023
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abionyx, Adial, Genentech, Hansa, Lupin, Pulmatrix, Quralis, Renibus, Roche, Salarius.
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Sanders using HELP position to advance Rx pricing agenda

July 11, 2023
By Mari Serebrov
The tension of clashing politics, policies and prescription drug pricing is coming to a head as U.S. Sen. Bernie Sanders (I-Vt.) acts on his threat to hold presidential appointments in the health arena hostage until President Joe Biden commits to do more to bring down drug prices.
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With MFDS expanded approval, Yuhan's Leclaza moving to first-line NSCLC treatment

July 11, 2023
By Marian (YoonJee) Chu
South Korean pharmaceutical giant Yuhan Corp. gained Korea’s MFDS approval to expand indications for its potent oral third-generation tyrosine kinase inhibitor Leclaza (lazertinib) as a first-line treatment for EGFR T790M mutation-positive non-small-cell lung cancer (NSCLC).
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Transcenta’s osemitamab on track for pivotal gastric cancer trials in Korea, China

July 11, 2023
By Tamra Sami
China’s Center for Drug Evaluation and South Korea’s Ministry of Food and Drug Safety cleared Transcenta Holdings to begin phase III pivotal trials of osemitamab (TST-001) in combination with nivolumab and chemotherapy for first-line treatment of HER2-negative, Claudin 18.2 expressing locally advanced or metastatic gastric or gastroesophageal cancer.
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