Regulatory Update

Westminster, Colo. – October 02, 2026 -- The Centers for Medicare & Medicaid Services has granted New Technology Add-On Payment status to Cerapedics Inc.'s PearlMatrix P-15 Peptide Enhanced Bone Graft, enabling hospitals to recoup up to 65% of the additional cost tied to the device starting October 02, 2026.

CMS approves alternative NTAP pathway tied to FDA Breakthrough Device status

PearlMatrix, a Class III drug-device combination product for skeletally mature patients with degenerative disc disease in the lumbar spine, received NTAP designation under CMS' alternative pathway, which recognizes products holding U.S. FDA Breakthrough Device designation. The reimbursement applies to eligible Medicare beneficiaries treated as inpatients at hospitals paid under the Medicare Inpatient Prospective Payment System.

Farmington Hills – October 02, 2026 -- Coretek has achieved ISO/IEC 42001 certification, becoming among the first organizations globally to earn the world's first international standard for Artificial Intelligence Management Systems (AIMS).

Certification validates Coretek's enterprise AI governance framework across the full AI lifecycle

The standard covers risk management, human oversight, security, continuous monitoring, regulatory alignment, and ongoing improvement of AI systems. Coretek, an AI, cloud, cybersecurity, and managed services provider, said the certification confirms its Artificial Intelligence Management System meets internationally recognized governance benchmarks.

Oakland, Calif. – October 01, 2026 -- Pacific Gas and Electric Company (PG&E) has filed a proposed 10-Year Electrical Undergrounding Plan (EUP) with the California Office of Energy Infrastructure Safety, projecting $117 billion in long-term benefits from burying 5,000 miles of distribution lines across more than 30 Northern and Central California counties between 2028 and 2037.

Undergrounding cuts wildfire ignition risk by 98% in targeted zones

PG&E says moving lines underground in high fire-threat districts nearly eliminates ignition risk and cuts outages by 90% in those areas. The utility estimates the $117 billion in projected benefits is more than 10 times the value of the proposed investment.

Boston – October 01, 2026 -- HoneyNaps, an AI-based sleep health technology company, has completed registration as a clinical research organization (CRO) with South Korea's National Enterprise for Clinical Trials (KoNECT), broadening its role in pharmaceutical and medical device trials worldwide.

HoneyNaps secures CRO registration with KoNECT, expanding multicenter trial capacity

The company has supported clinical trials involving more than 10,000 participants and can now operate multicenter, multidisciplinary studies under its new CRO status. The registration formalizes HoneyNaps' position as a provider of standardized sleep data analysis for pharmaceutical companies, medical device developers, and research organizations.

Dallas – October 01, 2026 -- Japan's Pharmaceuticals and Medical Devices Agency (PMDA) has accepted and granted priority review to Nanoscope Therapeutics' New Drug Application for MOGENRY (sonpiretigene isteparvovec, MCO-010), an optogenetic gene therapy for inherited retinal dystrophies (IRDs). If approved by the Ministry of Health, Labour and Welfare, MOGENRY would become the first disease-agnostic treatment available to IRD patients in Japan, a condition caused by mutations across more than 250 genes that leads to progressive photoreceptor loss and blindness.

Courbevoie – October 01, 2026 -- ACI EUROPE, Amadeus, IATA, IDEMIA Public Security and SITA have formed the Responsible Biometrics Travel Industry Coalition, pressing EU policymakers to prevent the bloc's Digital Omnibus legislation from restricting voluntary biometric use in air travel.

The five organizations argue the current legislative proposal, designed to simplify Europe's digital rulebook and strengthen competitiveness, could unintentionally curb passengers' ability to opt into biometric verification at airports.

Chennai – – September 30, 2026 -- MPS Limited said its Artificial Intelligence Management System has been certified to ISO/IEC 42001:2023, the first international standard for AI management systems, following a multi-stage external audit by DNV Business Assurance.

DNV audit confirms governed AI framework across risk, data and oversight controls

The certification, accredited by the Dutch Accreditation Council (RvA), confirms that MPS develops, deploys, and manages AI under a framework covering risk assessment, human oversight, data governance, transparency, and accountability across the full AI lifecycle. Every AI initiative within the certified scope is subject to structured risk and impact assessment, defined controls, and continuous monitoring.

Secaucus, N.J. – September 30, 2026 -- Pierre Fabre Pharmaceuticals Inc. (PFP) has resubmitted a Biologics License Application to the U.S. Food and Drug Administration for tabelecleucel, seeking approval as a monotherapy for adult and pediatric patients aged 2 and older with relapsed or refractory Epstein-Barr virus-positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have failed at least one prior therapy.

Resubmission follows April 2026 FDA alignment meeting

PFP filed the updated application after reaching agreement with the FDA during an April 2026 Type A meeting. The package includes an expanded dataset with additional patients and longer follow-up from the pivotal Phase 3 ALLELE study, which evaluates tabelecleucel in patients with EBV+ PTLD following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).

Vancouver – – September 30, 2026 -- Silvercorp Metals Inc. (TSX: SVM) (NYSE American: SVM) has extended its shareholder proxy voting deadline to September 30, 2026 at 4:00 p.m. Pacific time, after approving a further revision to a special resolution governing amendments to the Company's corporate Articles ahead of its annual general and special meeting scheduled for October 2, 2026.

Company narrows information it can demand from director nominees

Silvercorp has amended Article 16, which governs how shareholders nominate individuals for election to the Board. Having initially proposed limiting the information required to assess a nominee's independence, the Company has now gone further, removing its ability to request any nominee information beyond items specifically enumerated in Article 16, paragraph 4. A redline of the proposed changes was filed on SEDAR+ on September 29, 2026 under "Other Securityholder Documents."

Indianapolis – September 30, 2026 -- Eli Lilly and Company (NYSE: LLY) said its EBGLYSS (lebrikizumab-lbkz) monotherapy met the primary and secondary endpoints of the Phase 3b ADtouch study at Week 16, with more than half of treated patients achieving clear or almost clear skin on hands and feet (HF-IGA 0/1), the company disclosed ahead of the European Academy of Dermatology and Venereology Congress in Vienna, running Sept. 30-Oct. 3.

Trial enrolled 221 patients with moderate-to-severe hand and foot atopic dermatitis

The randomized, double-blind, placebo-controlled ADtouch trial (NCT06921759) assigned 221 adults and adolescents 1:1 to EBGLYSS 250 mg or placebo every two weeks over 16 weeks, following an initial loading dose. Participants had an inadequate response to topical therapies and applied moisturizer throughout the study.