Legal
Stalls Rovirosa FCPA Appeal, Seeks 30 More Days
DOJ filed a notice of appeal in the Rovirosa FCPA acquittal case, then admitted the Solicitor General hasn't decided if it wants one.
Masthead · Regulatory Intelligence Writer
Rebecca Lauren
Raleigh, NC · Joined May 2026
10+ years in regulatory strategy across biotech and small-molecule pharma. Writes the FDA enforcement and DOJ angles that move sponsor calendars. Raleigh, NC.
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Stories by Rebecca
FDA
Probes Lilly's China Trials, Deadline July 17
A House China Committee letter gives Eli Lilly until July 17 to explain trials run inside Chinese military hospitals and Xinjiang.
Legal
FBI Seizes NetNut, the Proxy Network Owned by Alarum's $ALAR
FBI and IRS-CI seize NetNut's domains over a 2-million-device botnet. Owner Alarum is a Nasdaq-listed company, not an anonymous darknet outfit.
Legal
Alibaba, AUS Pay $600M to Settle DOJ Drug Claims
Alibaba and Ant's AUS unit just bought their way out of a drug-trafficking case, $600M split between two penalty-forfeiture structures.
Legal
Fined $6.5M: Cliq Defied a 2015 FTC Fraud Order
A Nevada federal judge slashed the FTC's $52.9M ask to $6.5M, but still found Cliq in contempt for years of dodging a 2015 anti-fraud order.
Legal
Advances H.R. 9330: First Federal EWA Framework
House Financial Services just voted to define wage-access fees as not-loans, pulling the rug from under every state AG's payday-lending case.
Legal
Paid Up: AstraZeneca's $34M Kickback Settlement
AstraZeneca just became Ken Paxton's latest pharma kickback target, paying nearly $34M for 'free nurses' without admitting wrongdoing.
Legal
Iran's 60-Day Sanction Waiver Stalls U.S. Banks
A June 17 MOU put Iran sanctions on a wind-down clock. Banks still carrying BNP's nearly $1 billion OFAC settlement won't move yet.
Legal
CFTC Probes Polymarket; $3.1M Hack Follows
Polymarket faces its first CFTC probe under Chairman Selig after fake-trade allegations, plus a $3.1M frontend hack in the same week.
Legal
Stole Signal Backup Keys: FBI Warns of Russian Intel
FBI and CISA warn Russian intel groups have evolved Signal phishing to steal Backup Recovery Keys, exposing victims' full message history.
FDA
FDA Sets July 29 Adcomm for Capricor Deramiocel BLA
Capricor just got an FDA adcomm on deramiocel it didn't see coming, one year after Prasad pulled the last one off the Federal Register in real time.
Legal
NC Bans Third-Party Litigation Funding, $50K Fine
North Carolina's HB 315 makes it the only U.S. state to ban litigation funding outright, setting $50K per-violation fines and triple damages.
Legal
Illinois Signs BNPL Law; Providers Get Jan. 2028 Deadline
With 29% of Illinois families using BNPL for groceries, SB 3561 mandates IDFPR registration and capacity-to-repay checks by Jan. 2028.
Legal
FCC Filed NPRM on $2B E-Rate Sunset Risk
Carr's 2-1 vote puts the $2B E-Rate program on a path to sunset or deep cuts, and the congressional-intent argument could next reach Lifeline.
Legal
Sentenced: DraftKings Hacker Snoopy Owes $1.79M
DraftKings hacker Snoopy ran a shop selling stolen accounts, pocketed $465K in crypto, and now owes $1.79M in forfeiture and restitution.
Legal
Remanded: Jackson to Rule on CFPB's 556-Employee Plan
Judge Jackson's expedited CFPB remand pits a 556-employee restructuring plan against a $677M injunction compliance gap and new funding caps.
Legal
White House Cuts Quantum Crypto Deadline to 2030
A new executive order moves the post-quantum crypto deadline for high-value federal systems from 2035 to 2030, five years faster than planned.
Legal
Scattered Spider Duo Pleads Guilty on Trial Day 1
Jubair, 20, faces a US indictment over 120 intrusions and $115M in ransom, but the UK's six-week trial never made it past opening arguments.
FDA
Failed: Exelixis' Zanzalintinib NLM Endpoint; Dec. 3 PDUFA
Exelixis' zanzalintinib missed OS in the NLM subgroup, putting roughly half of a $1.3B peak-sales estimate at stake before the Dec. 3 FDA call.
Legal
Davenport Filed $20K Junk-Fee Map, States on Notice
With the CFPB retreating, NJ AG Davenport's $20K-per-violation junk-fee blueprint may hand every state AG a ready-made enforcement map.
Legal
Polymarket Faked $900K in Wins to Lure US Users
Polymarket staged $900K in fake wins for banned US users using copycat sites and a hired creator network. Its second marketing scandal in three weeks.
Legal
4 State AGs Probe FIFA World Cup Ticket Practices
Four state AGs are probing FIFA's World Cup tickets: seat bait-and-switch, sky-high variable pricing, and no consumer disclosure framework.
Legal
USTR Files Section 301 Against Germany Drug Pricing
USTR just filed Section 301 against Germany's €16B drug cost-cut plan. The UK deal is the blueprint, and a Sept. 22 hearing is now on the calendar.
Legal
Leaked: EU Commission Banking Draft Eyes Basel III Relief
EU Commission's leaked banking draft proposes Basel III relief for smaller lenders and capital relief on mortgages, but falls short of banks' ask.
FDA
Warned: Zoll Counted 27 Complaints, FDA Found 50
Zoll labeled its 731 ventilator hazard life-threatening, classified the likelihood as remote. FDA's April warning letter found 23 missing complaints.
FDA
Cleared 9-0: Moderna mFluvisa Puts $1B in Play
FDA adcomm voted 9-0 for Moderna's mFluvisa after Prasad's RTF letter threatened a $1B revenue opportunity and the 2028 breakeven goal.
Legal
Repurposes EU IP Addresses: Google Targets August 3
Google's August 3 deadline brings IP-based ad personalization into GDPR territory, and the ICO's May advice means advertisers carry the risk.
Legal
Hit 49 Times: Fortinet FortiSandbox Before CISA Acts
49 exploitation events, 13 sources across nine countries, and Fortinet's three FortiSandbox flaws still aren't on CISA's KEV catalog.
Legal
Vermont Signed 23rd State Privacy Law After Prior Veto
Vermont signed its 23rd-state privacy law, but the enforcement clause has a built-in PRA threat if the attorney general goes underfunded.
Legal
Cracked: 73,000 Fortinet Firewalls Hit by Russian Group
FortiBleed exposed credentials for 73,932 Fortinet firewalls across 194 countries, covering roughly half of all internet-accessible FortiGate devices.
Legal
Breached REDCap: China's UNC6508 Lurked 26 Months
A compliance rule named "Patroit" silently forwarded research emails to a Gmail account for months. The typos suggest manual upkeep.
Legal
FBI Seizes Outsider Enterprise in $1.9B AI Phishing Op
The FBI, Google, and Black Lotus Labs dismantled a China-based phishing ring with 9,000 fake sites and $1.9B in estimated consumer losses.
Legal
FBI Dismantles $1.9B Outsider Phishing Network
For $88 a week, Outsider gave cybercriminals a full phishing kit. The FBI and Google just shut it down after $1.9 billion in losses.
Legal
Conti Coder Pleads Guilty, Faces 20 Years
A Conti loader-coder pleads guilty to wire fraud, nearly three years after arrest in Ireland, and faces 20 years in prison.
Legal
Filed: Kyushu Electric's Missing Drive Holds 10.9M Records
Kyushu Electric's grid subsidiary lost a drive holding 10.9M customer records to a suspected theft, with METI demanding a full report by July 8.
Legal
Coupang Fined $412M for Breach Hitting 34M Accounts
A former employee silently accessed 34 million accounts while Coupang grew. The $412M Korean fine that just landed is only the start of the bill.
Legal
Seized: AudiA6 Washed $380M for Ransomware Gangs
AudiA6 laundered $380M for ransomware gangs across three years. A Poland arrest unraveled a network that 11 countries couldn't crack alone.
Legal
DOJ Charges Russian in Void Blizzard Hack of 11 U.S. Firms
Denis Obrezko charged for buying Void Blizzard's attack infrastructure; the FBI confirmed 11 U.S. company breaches, likely a fraction of the total.
Legal
FTC Halts NAA Mortgage Scam Built on CARES Act Lies
FTC's restraining order against National Amendment Assistance exposes how CARES Act branding still lures distressed homeowners into foreclosure.
FDA
Sanofi Cuts Riliprubart Phase 3 Over Efficacy Miss
Sanofi pulled the MOBILIZE phase 3 after an independent DMC found riliprubart unlikely to deliver, leaving $555M in projected CIDP sales at risk.
Legal
Judge Clears $38B Visa-Mastercard Swipe Fee Deal
$38B Visa-Mastercard swipe fee deal gets preliminary court nod, but the NRF says the fee cut just rolls rates back to 2023 levels.
FDA
Novo Fires Back as Lilly's Retatrutide Hits 30%
Lilly's retatrutide hits 30.3% weight loss at two years while Novo Nordisk's oral Wegovy crosses 3 million scripts and queues two H2 FDA decisions.
Legal
Meta Asks Court to Hold NSO in Contempt
Meta caught NSO running phishing campaigns in violation of a court-ordered no-hack ban, and it's now asking a federal judge for contempt.
FDA
Roche Paid $1.65B for Petrelintide's Phase 2 GI Data
Roche put $1.65B behind petrelintide's amylin mechanism. New ZUPREME-1 data from ADA 2026 shows just how clean the GI profile actually is.
FDA
Roche Bets on 9% Weight Loss as Obesity Sweet Spot
Roche and Zealand say 9% weight loss with placebo-like tolerability beats 20% if patients can't stay on the drug. Phase 3 starts H2 2026.
FDA
Hits 30% weight loss: Lilly triple-G surfaces cardiac signal
Retatrutide's 30.3% weight loss at 104 weeks rivals bariatric surgery, but seven arrhythmias in Transcend-T2D-1 complicate Lilly's NDA path.
FDA
Paid $10B, Pfizer Gets Berobenatide 15.9% Obesity Data
Pfizer's berobenatide posted 15.9% weight loss at 32 weeks with no plateau, its first ADA showing since the $10B Metsera deal closed.
Legal
Caught: Silent Ransom Group Sends Fake IT Into Law Firms
Silent Ransom Group sent imposters into dozens of law firm offices this year with USB drives. FBI and Mandiant filed concurrent warnings.
Legal
CFPB Makes Immigration Status a Reg Z Risk Factor
CFPB converts immigration status into a Reg Z income-continuity factor, forcing lenders to audit policies built under its reversed 2023 guidance.
Legal
ShinyHunters Leaked DentaQuest's 2.6M Records
After DentaQuest didn't pay ShinyHunters, 234 GB went public: 2.6M accounts with Medicaid IDs, government IDs, and dates of birth.
Legal
Sanctioned: Nobitex, 4 Iran Execs Under Economic Fury
Nobitex processed 50% of Iran's crypto inflows and routed stablecoins to the Central Bank. OFAC put it on the SDN list with its chairman and CEO.
FDA
FDA Hits Medline Drug Plant Over 9 Contamination Events
Medline's $6.3B IPO didn't shield it from two FDA warning letters, the second citing nine contamination events at its Illinois plant.
Legal
Four States, One Age-Signal Mandate, Zero Clarity
The 5th Circuit's May 28 stay put Texas SB 2420 back in force, but four-state ASAA compliance still hinges on a First Amendment ruling.
Legal
Filed: NFHA, SolasAI Sue CFPB Over ECOA Rollback
Four plaintiffs including AI bias-detection firm SolasAI sued CFPB in D.C. to block the April rule stripping disparate impact from ECOA.
FDA
Paid $1.2B for IBI363, Takeda Gets 47% 2-Year Survival
IBI363's phase 1 data put 47% of IO-resistant NSCLC patients alive at 24 months, the first real test of Takeda's $11.4B Innovent bet.
Legal
EU Bars Amazon, Google, Microsoft From Cloud Bids
EU's Cloud and AI Development Act mandates EU-built software in public tenders, a direct shot at Amazon, Google, and Microsoft's state contracts.
Legal
Delayed Again: Illinois IFPA Pushed to 2027
Illinois legislators delayed the IFPA swipe fee ban a second year in a row, but OCC preemption means the 2027 date may mean little for national banks.
Legal
OMB Files Grant Rule: Agencies Cancel at Any Time
OMB's proposed rule hands political appointees full grant veto power, bans DEI and gender research, and lets agencies cancel awards at will.
FDA
Cuts Metastasis Risk 20%: J&J's Erleada Targets Surgery
J&J's Proteus phase 3 shows Erleada cut metastasis risk 20% and nearly doubled time before additional therapy, from 3.5 to 6-plus years.
Legal
Kalshi, CFTC Sue Minnesota Over Felony Prediction Ban
The CFTC filed first and Kalshi filed second, and Minnesota is now fighting two federal preemption suits before its Aug. 1 felony ban takes effect.
FDA
Cuts DLBCL Risk 25%: Monjuvi Takes On Polivy
Incyte's phase 3 frontMIND data cuts DLBCL progression risk 25%, but seven drugs and a pending OS read leave the first-line market wide open.
FDA
Pfizer Cuts J&J's mCSPC Lead With 52% PFS Win
Talapro-3's 52% rPFS reduction spans both BRCA and non-BRCA HRR alterations, the full-spectrum breadth J&J's Akeega couldn't earn from FDA.
FDA
Summit's Ivonescimab OS Data Could Shake NSCLC Billions
Ivonescimab's HARMONi-6 OS data hits ASCO's plenary Sunday, with AbbVie, BioNTech, and Merck holding competing bets on who wins the PD-1/VEGF race.
FDA
FDA Warns Alchymars Again: Eight Years, Same Gaskets
FDA's second warning to Alchymars in eight years cites the same deteriorated equipment FDA cleared in 2023, plus an import alert on top.
Legal
GreenSky Pays $10M in Senior Lending Scheme
A $10M multistate settlement covers $6.5M in victim restitution, but GreenSky won't admit liability, pinning the scheme on 'prior ownership'.
Legal
Bonta Sues 23andMe Over 6.9M Genetic Data Breach
California's AG named a coding error in DNA Relatives, a five-month detection gap, and misleading public statements as the three pillars of the suit.
Legal
Disrupted: Glassworm Poisoned 300 GitHub Repos for Two Years
Glassworm spent two years poisoning 300+ GitHub repos until CrowdStrike and Google killed all four of its C2 channels simultaneously.
Legal
OMB Drops Federal Logging Mandate, Opens Six-Month Gap
OMB scrapped Biden's M-21-31 logging mandate before CISA's replacement is ready, giving agencies six months with no enforceable standard.
Legal
ShinyHunters Dumps 185K 7-Eleven Records After Ransom
ShinyHunters dumped 185,300 people's data after 7-Eleven refused ransom: names, dates of birth, and addresses from a Salesforce breach.
Legal
Fed Proposes FinTech Payment Accounts Capped at $1B
The Fed's new payment account category hands FinTechs direct settlement access while stripping interest, discount window, and intraday credit.
Legal
C.A. Cloud Execs Plead Guilty to Tech Fraud Cover-Up
C.A. Cloud's CEO and CSO pleaded guilty to concealing a five-year fraud scheme that funneled calls to scammers targeting elderly victims worldwide.
Legal
FTC Hits Cox Media With $880K for Fake AI Ads
Cox Media Group's "Active Listening" AI never used voice data; the FTC's $880K settlement shows it was email lists at markup. Small businesses paid.
FDA
CHMP Backs Camizestrant After ODAC's 3-6 No Vote
CHMP backed camizestrant for ER+/HER2- breast cancer as ODAC voted 3-6 against. Europe and the US disagree on trial design, not the drug's efficacy.
FDA
Gilead Wins Hepcludex Nod Four Years After FDA Rejection
Gilead's Hepcludex wins US approval four years after a manufacturing CRL, becoming the first treatment for HDV in a market of up to 80,000 patients.
Legal
Signed May 19: Trump EO Puts Fed Master Accounts in Play
Trump's May 19 EO gives the Fed 120 days to weigh fintech access to payment rails. The master account question finally has a clock.
Legal
Ukraine IDs 18-Year-Old Behind $721K Account Theft
Ukrainian cyberpolice identified the Odesa teen on May 12: he ran the infrastructure behind $721K in unauthorized purchases from 28,000 accounts.
FDA
Bimzelx Beats Skyrizi 49% to 38% on ACR50 in PsA Trial
BE BOLD's Phase 3 data put a 10-point ACR50 gap between Bimzelx and Skyrizi, the $17.56B drug AbbVie built its post-Humira franchise on.
Legal
SEC Clears Methode Electronics After Dual Subpoenas
SEC closed its FCPA probe of Methode Electronics with no enforcement action, after two subpoenas covering executive pay and hotline tips.
FDA
Resigned: Makary, Four FDA Leaders Out in a Week
Makary's exit triggered a cascade: four more FDA leaders gone in a week, and biotech wants Richard Pazdur next. The White House hasn't said yes.
