Regulatory Compliance

Pierre Fabre Resubmits FDA BLA for Tabelecleucel in Rare Post-Transplant Cancer

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Pierre Fabre Resubmits FDA BLA for Tabelecleucel in Rare Post-Transplant Cancer

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).

Netwrix: 31% of Healthcare Orgs Hit by Unauthorized Identity Access

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Netwrix: 31% of Healthcare Orgs Hit by Unauthorized Identity Access

Frisco, Texas – September 30, 2026 -- Thirty-one percent of healthcare organizations experienced unauthorized identities accessing sensitive data in the past year, compared with 24% across other industries, according to new healthcare findings from Netwrix's 2026 Data and Identity Security Report. Among healthcare organizations that suffered an incident, 33% reported costs exceeding $250,000, versus 21% in other sectors.

Healthcare ranks last among 16 industries on Active Directory confidence

Only 14% of healthcare organizations said they are fully confident their Active Directory environments are free of privilege escalation risks, compared with 26% across all industries surveyed. Eighty-six percent lack full confidence in their AD security, the lowest ranking among the 16 industries with sufficient survey representation for comparison.

Lilly's EBGLYSS Hits Primary Endpoint in Phase 3b Hand-Foot Eczema Trial

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Lilly's EBGLYSS Hits Primary Endpoint in Phase 3b Hand-Foot Eczema Trial

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.

AppZen Launches AI Agents to Automate Corporate Card Compliance

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AppZen Launches AI Agents to Automate Corporate Card Compliance

San Jose – September 30, 2026 -- AppZen has launched Autonomous Cards, an AI agent layer that automates compliance, monitoring and spend intelligence for enterprise corporate card programs, as commercial card volume in the U.S. hit $2.23 trillion in 2024, up 4.5% year-over-year, according to the Nilson Report.

AppZen deploys AI agents to process transactions without replacing existing card infrastructure

Autonomous Cards connects directly to companies' existing purchasing, virtual, fleet, ghost, and lodge card programs, keeping current banks and issuers intact while adding a unified AI and compliance layer. The system continuously monitors eligible transactions, using card data, merchant details, Level 3 detail, supporting documents and company policy to determine what was purchased and whether it complies with internal rules.

RBC Capital Markets Gains General Clearing Member Status at ECC

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RBC Capital Markets Gains General Clearing Member Status at ECC

London – – September 30, 2026 -- RBC Capital Markets has been awarded General Clearing Member (GCM) status by European Commodity Clearing AG (ECC), enabling the bank to clear and settle transactions on behalf of Non-Clearing Members across Europe's energy and commodity markets.

RBC gains authorization to clear power, gas and carbon products via EEX

As a General Clearing Member, RBC Capital Markets can now offer a full suite of clearing services covering power and gas futures and spot contracts, European Energy Exchange (EEX) carbon auctions, and a broader range of products across the wider EEX platform.

The status extends the bank's clearing reach to clients that include some of Europe's largest energy producers, utilities and financial institutions, according to the company.

SOFTSWISS Launches 2027 iGaming Trends Report With AWS, WorldGaming

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SOFTSWISS Launches 2027 iGaming Trends Report With AWS, WorldGaming

Lisbon – September 30, 2026 -- SOFTSWISS has released its 2027 iGaming Trends report, drawing on a survey of more than 500 industry experts and analysis of over 480,000 media headlines to map the sector's regulatory, technological and competitive trajectory.

Fifth anniversary edition adds cross-sector benchmarking against e-commerce and crypto

Marking five years of publication, this edition introduces a new "Beyond iGaming" framework comparing the industry against e-commerce, sports, film, gaming, streaming, e-pharma and crypto on metrics including market size, growth rate, regulatory maturity and digital adoption.

88% of C-Suite Leaders Fear Job Loss Over Data Sovereignty Gaps

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88% of C-Suite Leaders Fear Job Loss Over Data Sovereignty Gaps

London – September 30, 2026 -- A new global study from Everpure (NYSE: P) finds that 64% of enterprises operate without a formal data sovereignty strategy, even as 88% of large-enterprise C-suite leaders believe a sovereignty failure could cost them their job.

Executives fear financial and reputational fallout from sovereignty failures

The Global Data Sovereignty Report 2026, based on a Vanson Bourne survey of 2,100 C-suite and IT leaders across the UK, France, Germany, Australia, Japan, South Korea, Singapore and India in June 2026, found 91% of respondents worry about financial and reputational damage tied to sovereignty lapses. Ninety percent recognize data sovereignty as a core business concern.

Autoliv Retires 1.2 Million Shares, Cuts Issued Stock Count

Stockholm – September 30, 2026 -- Autoliv, Inc. has retired 1,232,671 shares of common stock repurchased during the third quarter, reducing its total issued shares to 74,421,702 as of September 30, 2026.

Outstanding shares now stand at 72,006,695 following the retirement

Each outstanding share carries one vote. The retirement lowers the total count of issued shares, a mechanical adjustment tied to Autoliv's ongoing buyback program.

Autoliv holds 2,415,007 shares in treasury with no voting rights

Under Delaware law, treasury shares carry no voting rights and no entitlement to participate in distributions. The company disclosed the change as required under the Swedish Financial Instruments Trading Act (lagen (1991:980) om handel med finansiella instrument), with the filing distributed on September 30, 2026, at 08:00 CET.

Autoliv trades on the New York Stock Exchange under ALV and on Nasdaq Stockholm under ALIVsdb.

Roche Unit Launches Triple Newborn Screening Test for SMA, SCID, SCD

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Roche Unit Launches Triple Newborn Screening Test for SMA, SCID, SCD

Berlin – – September 30, 2026 -- TIB MOLBIOL, a subsidiary of Roche Diagnostics, has launched the LightMix® Newborn TREC/SMN1/HBB kit, an IVDR-approved in vitro diagnostic test that simultaneously screens newborns for Spinal Muscular Atrophy (SMA), Severe Combined Immunodeficiency Disease (SCID), and Sickle Cell Disease (SCD) in countries accepting the CE mark.

Single kit consolidates three critical newborn screening panels for hospital labs

The test runs on established LightCycler systems, giving private and academic hospital laboratories a ready-to-use solution that integrates into existing workflows without requiring new infrastructure investment.

NTT TechnoCross Wins Frost & Sullivan PAM Award Third Year Running

San Antonio – September 30, 2026 -- NTT TechnoCross has secured Frost & Sullivan's 2026 Japanese Company of the Year Recognition in privileged access management for the third consecutive year, citing its unified governance platform for enterprise cybersecurity.

Frost & Sullivan cites unified governance across human and non-human identities

Frost & Sullivan's evaluation benchmarked NTT TechnoCross across strategy effectiveness and strategy execution, with the company excelling in both dimensions. Vivien Pua, Industry Principal at Frost & Sullivan, noted that the company's iDoperation platform brings privileged account governance, access control, monitoring, auditing, analytics, and just-in-time access capabilities into a single system, aligning with enterprise demand for dynamic access management beyond traditional account protection.