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BioWorld - Wednesday, May 13, 2026
Home » Topics » Regulatory

Regulatory
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CMS’ gene therapy access model goes live, with 33 states on board

July 16, 2025
By Jennifer Boggs
No Comments
A total of 33 states, plus the District of Columbia and Puerto Rico, agreed to participate in the U.S. CMS’ voluntary, outcomes-based program aimed at helping state Medicaid programs cover high-priced cell and gene therapies, starting with therapies for sickle cell disease.
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United Kingdom flag, map

Life sciences strategy to reduce UK approval costs by 25%

July 16, 2025
By Nuala Moran
No Comments
The U.K. government has committed to reduce the cost of drug and device approvals by 25% as part of a long-awaited life sciences strategy which sets out a 10-year plan for the sector.
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Prescription drug bottles and pills

Rx tariffs a few weeks away?

July 16, 2025
By Mari Serebrov
No Comments
“Pharmaceuticals will be tariffed, probably at the end of the month,” U.S. President Donald Trump said, as he provided a few more details about his proposed global biopharma sector tariff. “We’re going to start off with a low tariff and give the pharmaceutical companies a year or so to build. And then we’re going to make it a very high tariff.”
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Woman  in military clothing talking with psychologist

FDA wants more data for Otsuka’s sNDA in PTSD

July 16, 2025
By Lee Landenberger
No Comments
The U.S. FDA is insisting that another study is needed to bolster the sNDA for Rexulti (brexpiprazole) from Otsuka Pharmaceutical Co. Ltd. in treating adults with post-traumatic stress disorder (PTSD). The agency’s Psychopharmacologic Drugs Advisory Committee and the company, one of Japan’s biggest pharmas, will discuss this during July 18’s adcom hearing regarding the efficacy of Rexulti in combination with sertraline.
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Optogenetics illustration
Ocular

Aavantgarde Bio cleared to begin clinical study of Stargardt disease gene therapy in US

July 16, 2025
No Comments
The U.S. FDA has cleared Aavantgarde Bio Srl’s IND application for AAVB-039, the company’s gene therapy program for Stargardt disease, the most common inherited form of macular degeneration.
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Doctor measuring patient's waist
Endocrine/metabolic

Palatin Technologies reports efficacy of PL-7737 in obesity model

July 16, 2025
No Comments
Palatin Technologies Inc. has announced preclinical results for PL-7737, an oral selective melanocortin MC4 receptor (MC4R) agonist, showing effectiveness in rodent models of obesity.
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Synchrony’s Libairty airway clearance system

Synchrony receives FDA OK for Libairty airway clearance system

July 15, 2025
By Shani Alexander
Synchrony Medical Ltd. received the greenlight from the U.S. FDA for its Libairty airway clearance system which is expected to transform the lives of people with chronic lung diseases. The company is now looking to raise $5 million in series A funding to support the launch of the product in the U.S. later this year.
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Telehealth illustration

CMS takes aim at skin substitutes, telehealth in 2026 doc fee draft

July 15, 2025
By Mark McCarty
The U.S. Centers for Medicare & Medicaid Services (CMS) has pulled off the gloves when it comes to spending on skin substitutes in the draft Medicare physician fee schedule for 2026, proposing a payment methodology that would slash spending by 90%. However, the doc fee draft also proposes to simplify the process by which telehealth coverage is provided for a physician service, a move that may significantly expand the types of services that can be handled without an in-office visit.
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Doctor with illustration of kidneys

CMS lists 6 specialists as part of hypertension team in RDN memo

July 15, 2025
By Mark McCarty
To the surprise of no one in the device industry, the Medicare national coverage analysis for renal denervation (RDN) includes both radiofrequency and ultrasound technologies, but the agency has listed a range of specialists to be part of the patient’s care team, including but not limited to an endocrinologist.
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Multiple myeloma illustration

Adcom briefing docs eye toxicity of GSK’s Blenrep

July 15, 2025
By Randy Osborne
No Comments
As the July 23 PDUFA date nears for GSK plc’s Blenrep (belantamab mafodotin), the U.S. FDA’s Oncologic Drugs Advisory Committee will decide July 17 on whether available data justify the return to market of the antibody-drug conjugate as a therapy for relapsed/refractory multiple myeloma, and briefing documents made public ahead of the meeting laid out the issues.
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