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Sarepta signage

Elevidys’ second liver death hits Sarepta, sends DMD ripples

June 16, 2025
By Randy Osborne
No Comments
How the U.S. FDA might respond became a serious question for Wall Street as Sarepta Therapeutics Inc. made known a second death due to acute liver failure with gene therapy Elevidys (delandistrogene moxeparvovec), cleared for Duchenne muscular dystrophy (DMD). Shares of Cambridge, Mass.-based Sarepta (NASDAQ:SRPT) closed June 16 at $20.94, down $15.24, or 42%, as Wall Street digested the news.
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CAR T illustration
Immuno-oncology

Myrio’s PHOX2B PC-CAR T for neuroblastoma gains IND clearance

June 16, 2025
No Comments
Myrio Therapeutics Pty Ltd. is set to advance lead product PHOX2B PC-CAR T (PHOX2B peptide-centric chimeric antigen receptor autologous T cells) into clinical trials for relapsed neuroblastoma following IND clearance by the FDA. The first patient will be enrolled around mid-year.
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omniasecure defib lead

FDA approves Medtronic Omniasecure defib lead

June 13, 2025
By Annette Boyle
Medtronic plc received U.S. FDA approval for its Omniasecure defibrillation lead for placement in the right ventricle to treat arrhythmias. Medtronic said the lead is the smallest made at 4.7 French or 1.6 mm, making it suitable for individuals as young as age 12 and others with smaller anatomies, particularly women.
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Art concept for bladder

Zusduri flurry ends; ‘set up’ at ODAC, Urogen prevails with FDA

June 13, 2025
By Randy Osborne
No Comments
During a conference call after the U.S. FDA approval of Zusduri (mitomycin), Urogen Pharma Ltd. CEO Liz Barrett offered candid observations about a “roller-coaster ride” sparked by a mixed-outcome advisory panel meeting held May 21. Zusduri is designed to treat recurrent low-grade, intermediate-risk, non-muscle invasive bladder cancer.
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New ACIP members to review data for current vaccine schedules

June 12, 2025
By Mari Serebrov
No Comments
And then there were eight. That is, eight members of the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP).Two days after dismissing the 17 members of the committee, Health and Human Services Secretary Robert Kennedy named eight new members to the panel. Eight is the minimum required for a quorum, which will be necessary for the June 25-27 ACIP meeting.
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Win for ROS1 as Nuvation’s Ibtrozi cleared for NSCLC

June 12, 2025
By Randy Osborne
No Comments
Slightly ahead of the assigned June 23 PDUFA date, Nuvation Bio Inc. scored the U.S. FDA’s go-ahead for Ibtrozi (taletrectinib) to treat adults with locally advanced or metastatic ROS1-positive non-small-cell lung cancer (NSCLC).
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Steadying hand while reaching for glass
Neurology/psychiatric

Capsida’s CAP-003 receives IND clearance for Parkinson’s disease with GBA mutations

June 12, 2025
No Comments
Capsida Biotherapeutics Inc. has obtained IND clearance from the FDA for CAP-003, an intravenously administered gene therapy, for Parkinson’s disease associated with GBA mutations (PD-GBA). A phase I/II trial will begin dosing in the third quarter of this year.
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Money sack with British pound symbol

NHS deploying Histosonics' Edison to slash health care red tape

June 11, 2025
By Mark McCarty
The U.K.’s National Health Service reported June 10 that patients in the U.K. will be the first in Europe to enjoy the benefits of the Edison ultrasound histotripsy for ablation of liver cancer tumors as part of an effort to bring products to market more quickly to deal with unmet needs.
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Doctor with illustration of kidneys

MFDS clears world’s first ECG-based AI kidney disease software

June 11, 2025
By Marian (YoonJee) Chu
South Korea’s Ministry of Food and Drug Safety on June 9 approved Vuno Inc’s AI-based Med-DeepECG Kidney software as a non-invasive method to screen for kidney dysfunction.
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ABPI: UK’s rebate rates ‘send a terrible message’ to global investors

June 11, 2025
By Nuala Moran
No Comments
The U.K. government has doubled the rate that pharmaceutical companies must repay on sales of branded drugs, under the statutory rebate scheme, to a record 31.3%. Only 1-2% of total sales of branded drugs fall under the statutory scheme, but the increase is seen as a sign that an ongoing review of the voluntary scheme is not going well.
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