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Home » Topics » Regulatory

Regulatory
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Scientist looking in microscope, chemical structure concept image
Cancer

Simcere’s POLθ inhibitor to enter clinic in China for advanced solid tumors

Aug. 23, 2024
Simcere Zaiming Pharmaceutical Co. Ltd. has obtained clinical trial approval from China’s National Medical Products Administration (NMPA) for SIM-0508, a small-molecule inhibitor of DNA polymerase θ (POLθ), allowing initiation of clinical trials in locally advanced or metastatic solid tumors.
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3D cross-section illustration of muscle anatomy
Neurology/psychiatric

Ractigen’s saRNA therapeutic named US orphan drug for Duchenne and Becker muscular dystrophies

Aug. 23, 2024
Ractigen Therapeutics Co. Ltd.’s small activating RNA (saRNA) therapeutic, RAG-18, has been awarded U.S. orphan drug designation for the treatment of Duchenne muscular dystrophy (DMD) and Becker muscular dystrophy.
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Thumbs down

Implant still can’t; Vivani bonny vs. Intarcia with exenatide?

Aug. 23, 2024
By Randy Osborne
The long struggle by Boston-based I2o Therapeutics Inc.’s business unit Intarcia Therapeutics to get long-lasting exenatide for diabetes onto the market ended with a final thumbs-down from the U.S. FDA because of safety concerns. At issue was ITCA-650, a twice-yearly implantable exenatide-device combo meant to improve glycemic control in adults with type 2 diabetes.
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Gavel and vials

FTC noncompete ban struck down by district court

Aug. 22, 2024
By Lee Landenberger
The U.S. Federal Trade Commission’s broad rule banning noncompete employment clauses was struck down by the U.S. District Court for the Northern District of Texas. In a final judgment from Judge Ada Brown, the court set aside the noncompete rule, saying it won’t be enforced or take effect as planned on Sept. 4.
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Medtronic Percept RC

FDA approves Medtronic Asleep DBS surgery, expanded MRI labeling

Aug. 22, 2024
By Shani Alexander
The U.S. FDA recently granted Medtronic plc approval for its deep brain stimulation (DBS) system to be used to treat Parkinson’s disease or essential tremor while a patient is asleep, under general anesthesia. The approval gives patients another option for DBS therapy which can transform their quality of life, Amaza Reitmeier, vice president and general manager for Medtronic brain modulation, told BioWorld in an interview.
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Regulatory icons

FDA sees change in sterilization site as inappropriate for PCCPs

Aug. 22, 2024
By Mark McCarty
The U.S. FDA’s draft guidance for predetermined change control protocols for all device types fills in a gap left by previous draft guidance, but there is one potential stopping point for class III devices.
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Pancreatic cancer cells.
Cancer

Monopar’s MNPR-101-Lu receives Australian HREC clearance for trial in advanced cancers

Aug. 22, 2024
Monopar Therapeutics Inc. has received Human Research Ethics Committee (HREC) clearance in Australia to initiate a phase I therapeutic trial of its novel radiopharmaceutical MNPR-101-Lu. MNPR-101-Lu combines the therapeutic radioisotope lutetium-177 (Lu-177) with Monopar’s proprietary first-in-class humanized monoclonal antibody MNPR-101, which is highly selective against the urokinase plasminogen activator receptor (uPAR).
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Multiple sclerosis
Neurology/psychiatric

Immpact Bio’s CD19/CD20 bispecific CAR T-cell therapy obtains IND clearance for MS

Aug. 22, 2024
Immpact Bio USA Inc. has obtained IND clearance from the FDA for IMPT-514, a CD19/CD20 bispecific chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with multiple sclerosis (MS). A phase I trial will focus on patients who have suboptimal disease control despite prior treatment with high efficacy disease-modifying therapies in all forms of MS.
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Innovent wins nod for China’s first KRAS G12C lung cancer drug

Aug. 22, 2024
By Marian (YoonJee) Chu
The National Medical Products Administration (NMPA) has approved Innovent Biologics Inc.’s Dupert (fulzerasib) as the first KRAS G12C inhibitor in China to treat select patients with non-small-cell lung cancer (NSCLC).
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Man piecing together a puzzle

UK clears Leqembi for Alzheimer’s; NHS unlikely to embrace cost

Aug. 22, 2024
By Nuala Moran
The U.K. has become the first country in Europe to approve Leqembi (lecanemab), but as the breakthrough decision was announced, the health technology assessment body NICE said the benefits are too small to justify the cost of providing the Alzheimer’s disease therapy on the National Health Service (NHS).
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