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BioWorld - Monday, September 25, 2023
Home » Topics » Regulatory

Regulatory
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Neurology/Psychiatric

Lapix’s TIM-3/4 receptor agonist cleared to enter clinic for multiple sclerosis

Sep. 19, 2023
No Comments
Lapix Therapeutics Inc. has received IND clearance from the FDA to initiate a phase I trial of its first-in-class, immune tolerance restoration small molecule, LPX-TI641, for the treatment of multiple sclerosis (MS).
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Biosimilar drugs

US biosimilar labeling distinctions a thing of the past?

Sep. 18, 2023
By Mari Serebrov
No Comments
If the U.S. FDA has its way, biosimilars and interchangeable biosimilars would no longer be a difference with a distinction – at least when it comes to labeling. Instead of distinguishing between the two, the agency is recommending that the labeling for both follow-ons include a “biosimilarity statement.”
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Leukemia illustration

FDA grants broad label for GSK’s momelotinib in myelofibrosis with anemia

Sep. 18, 2023
By Jennifer Boggs and Caroline Richards
No Comments
Five years after Gilead Sciences Inc. gave up on momelotinib in the wake of two phase III failures in myelofibrosis, the JAK1/2 and ACVR1 inhibitor has found its way to the market in the hands of GSK plc. Branded Ojjaara, the drug gained U.S. FDA approval for use in intermediate- or high-risk myelofibrosis patients with anemia regardless of prior administration with JAK inhibitors such as Jakafi (ruxolitinib, Incyte Corp.).
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Regulatory actions for Sept. 18, 2023

Sep. 18, 2023
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Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: B.Braun, Cerevasc, Vonco, Ossdsign.
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Regulatory actions for Sept. 18, 2023

Sep. 18, 2023
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Almirall, Argenx, Ascendis, Astrazeneca, Daiichi Sankyo, Hemogenyx, Iovance, Merck, Moderna, PTC, UCB, Vertex.
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Antibiotic resistant bacteria inside a biofilm,
Infection

Contrafect files IND for CF-370 for hospital-acquired and ventilator-associated bacterial pneumonias

Sep. 18, 2023
No Comments
Contrafect Corp. has submitted an IND application to the FDA for its intravenous antibacterial agent, CF-370, for treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia.
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NICE says cryotherapy for chronic rhinitis not ready for prime time

Sep. 18, 2023
By Mark McCarty
No Comments

Chronic rhinitis is drawing more attention from medical device makers in recent years, with solutions including cryotherapy and temperature-controlled radiofrequency disruption of posterior nasal nerves to halt the condition.


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Repeat defender: PTC to appeal Translarna case in Europe – again

Sep. 15, 2023
By Randy Osborne
No Comments
“We’re going to battle,” PTC Therapeutics Inc. CEO Matthew Klein said, responding to a surprise negative opinion from the EMA’s Committee for Medicinal Products for Human Use on converting the conditional marketing authorization to full status for Translarna (ataluren) in the treatment of nonsense mutation Duchenne muscular dystrophy. The opinion applies to the renewal of the existing conditional authorization, too.
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Regulatory actions for Sept. 15, 2023

Sep. 15, 2023
No Comments
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Alnylam, Dizal, Hemogenyx, Innocare, Neurocrine, Oncopeptides, Oscotec.
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insightec-exablate-neuro-12-13.png

Insightec secures additional CE mark for Exablate Neuro to treat essential tremors

Sep. 15, 2023
By Shani Alexander
No Comments

Insightec Ltd. broadened its CE mark approval for the Exablate Neuro, a focused ultrasound platform which treats essential tremors, to allow patients to have their second side treated. With some 60 million people estimated to be affected by essential tremor globally, Insightec hopes that with both sides treated, patients will have full body relief from tremor and therefore be able to resume everyday activities.


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