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Home » Topics » Regulatory

Regulatory
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Biogen’s ataxia drug, Crispr’s sickle cell therapy cleared in EU

Feb. 13, 2024
By Caroline Richards
The European Commission approved two therapies for progressive, genetic diseases: Biogen Inc.’s Friedreich’s ataxia drug, Skyclarys (omaveloxolone), and Crispr Therapeutics AG’s CRISPR/Cas9 gene therapy for sickle cell disease and transfusion-dependent beta-thalassemia, Casgevy (exagamglogene autotemcel, exa-cel).
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U.S. FDA headquarters

FDA issues patent term extension data for multiple devices

Feb. 13, 2024
By Mark McCarty
The U.S. FDA has posted information on the regulatory review period for several medical devices that incorporate patented inventions, such as the determination for the Simplify artificial cervical disc by Simplify Medical Inc., of Sunnyvale, Calif. According to the FDA, the company seeks to tack nearly 1,100 days back on to the patent in question, an additional three years that may play a significant role in the company’s attempt to monetize the patent in question.
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US PTO guidelines for AI suggest amplified need for documentation

Feb. 13, 2024
By Mark McCarty
The U.S. Patent and Trademark Office (PTO) has released a draft version of patent examiner guidelines to address the increasing use of artificial intelligence (AI) in the inventive process, reflecting the standing U.S. position that AI cannot be an inventor.
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OP5_INSU_POD_PDM_NoADH_RIGHT_RGB.jpg

Insulet integrates Abbott Libre 2 with its Omnipod 5 in Europe

Feb. 13, 2024
By Shani Alexander
Insulet Corp. received the greenlight from EU regulators to combine its Omnipod 5 automated insulin delivery (AID) system with Abbott Laboratories Freestyle Libre 2 Plus sensor to treat individuals aged two years and older with type 1 diabetes.
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Samsung Galaxy Watch

FDA approves Samsung’s sleep apnea feature on Galaxy watch, phone

Feb. 13, 2024
By Marian (YoonJee) Chu
The U.S. FDA approved a new feature for detecting obstructive sleep apnea (OSA) on the Samsung Galaxy watch and smartphone, Samsung Electronics Co. Ltd. said on Feb. 10.
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Masimo MightySat pulse ox

FDA hands Masimo first clearance for medical-grade OTC pulse ox

Feb. 13, 2024
By Annette Boyle
Masimo Corp. received a pinch of good news with the U.S. FDA’s clearance of its medical-grade fingertip pulse oximeter, Mightysat Medical, for over-the-counter (OTC) sale. The device uses the same technology as Masimo’s Set pulse oximetry used in hospitals and clinics.
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SARS-CoV-2 virus particles
Infection

Trawsfynydd’s Mpro inhibitor TRX-01 cleared to begin first-in-human study for COVID-19

Feb. 13, 2024
Trawsfynydd Therapeutics Inc. has received approval to initiate a first-in-man phase I trial of the novel best-in-class COVID-19 treatment, TRX-01, an inhibitor targeting the SARS-CoV-2 viral main protease (3CL, Mpro).
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FDA Approved stamp

Takeda quickly follows Sanofi-Regeneron with esophagitis approval

Feb. 12, 2024
By Lee Landenberger
Less than a month after the U.S. FDA approved Sanofi SA and Regeneron Pharmaceuticals Inc.’s bestseller Dupixent (dupilumab) for treating eosinophilic esophagitis in children ages 1 to 11, the agency has approved Takeda Pharmaceutical Co. Ltd.’s Eohilia (budesonide oral suspension) for the same indication but for an older group.
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US FDA codifies policy for deemed biologics

Feb. 12, 2024
By Mari Serebrov
Weaving in a loose regulatory end from March 2020 when it deemed nearly 100 NDAs as BLAs, the U.S. FDA released a final rule codifying its current approach to the use of drug master files for those products and their potential biosimilar competition.
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Clinical data illustration

US FDA hints at wider use of data monitoring for clinical trials

Feb. 12, 2024
By Mark McCarty
The U.S. FDA has released a draft guidance for the use of data monitoring committees (DMCs) for clinical trials for devices and drugs, which would overwrite a similar guidance from 2006. This new draft guidance explicitly states that clinical studies more commonly employ DMCs than was the case 18 years ago and would seem to suggest that the agency will more routinely require the use of DMCs than was common practice in the past.
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