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Home » Topics » Regulatory

Regulatory
Regulatory RSS Feed RSS

Redhill shares climb eightfold on Talicia exclusivity

Nov. 29, 2023
By Karen Carey
Redhill Biopharma Ltd.’s stock (NASDAQ:RDHL) has soared in recent days following news that the U.S. FDA granted five years of market exclusivity for Talicia, a first-line therapy for eradication of Helicobacter pylori infection, which affects about 35% of the U.S. adult population.
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Brain and encephalography

US warns of safety issues from seizure medications; UK restricts valproate

Nov. 29, 2023
By Karen Carey and Mari Serebrov
The U.S. FDA put out a safety warning Nov. 28 that antiseizure drugs levetiracetam and clobazam can cause a rare but serious hypersensitivity drug reaction that may start as a rash but can progress to injure internal organs. In addition, U.K. health care providers are being told to get a plan in place now to implement the first phase of the Medicines and Healthcare products Regulatory Agency’s new regulatory measures  to reduce the risks of valproate, a treatment for epilepsy and bipolar disorder.
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COVID-19 mRNA vaccine vials, syringe

Japan approves first self-amplifying mRNA COVID-19 vaccine from CSL, Arcturus

Nov. 29, 2023
By Tamra Sami
In a global first, Japan's Ministry of Health, Labor and Welfare has approved CSL Ltd.’s and Arcturus Therapeutics Inc.’s self-amplifying messenger RNA (sa-mRNA) vaccine (ARCT-154) for COVID-19 in adults. The approval marks the first milestone for a November 2022 licensing deal under which CSL subsidiary CSL Seqirus in-licensed Arcturus’ late-stage sa-mRNA vaccine platform technology.
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Philips faces the heat with new thermal CPAP warning from FDA

Nov. 29, 2023
By Holland Johnson
Philips Respironics Inc.’s nightmares with its Dreamstation continuous positive airway pressure (CPAP) line of products continued with a fresh warning from the U.S. FDA of reports involving thermal issues with a newer iteration of the machine, some of which cited patient injuries.
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BrainSpec

Brainspec AI FDA cleared for noninvasive brain chemistry analysis

Nov. 29, 2023
By Annette Boyle
Brainspec Inc. received U.S. FDA 510(k) clearance for use of its artificial intelligence platform, Brainspec Core, in noninvasive measurement of brain chemistry using magnetic resonance spectroscopy (MRS).
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Bivacore TAH

Bivacor pumped by FDA IDE approval for total artificial heart study

Nov. 29, 2023
By Annette Boyle
“The FDA approval to begin the Bivacor Total Artificial Heart EFS is a critical milestone for Bivacor and is another validation of the remarkable work and accomplishments of the entire Bivacor team. This device will provide a unique approach to help patients currently with limited clinical options,” said William Cohn, heart surgeon at the Texas Heart Institute and Bivacor chief medical officer.
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Regulatory actions for Nov. 29, 2023

Nov. 29, 2023
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: CTL Amedica, Icecure Medical, Zilia.
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Microenvironment of a HER2-expressing breast tumor
Immuno-oncology

Carisma's HER2-targeting CT-0525 cleared to enter clinic

Nov. 29, 2023
Carisma Therapeutics Inc. has received FDA clearance of its IND application for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor (CAR)-monocyte cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).
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FDA investigating risk with CAR T-cell therapies

Nov. 28, 2023
By Mari Serebrov
Reports of T-cell malignancies, including lymphoma, have the U.S. FDA investigating the risks for patients who received certain autologous CAR T-cell immunotherapies.
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Aldeyra already moving on new dry eye trial as it collects FDA CRL

Nov. 28, 2023
By Jennifer Boggs
As expected, Aldeyra Therapeutics Inc. received a complete response letter (CRL) from the U.S. FDA regarding its NDA for reproxalap in dry eye disease, with the agency requiring “at least one” additional study to prove efficacy of the reactive aldehyde species, or RASP, modulator.
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