Healthcare & Life Sciences

PMPRB Releases New Guidelines for Drug Price Monitoring Effective January 1

The Patented Medicine Prices Review Board (PMPRB) has released new guidelines governing how staff monitor and review patented drug prices in Canada. The guidelines establish updated procedures for price excessive price hearings and related administrative processes. The new guidelines take effect January 1, 2025.

Public Drug Plan Spending Rose $3.4B Over 5 Years Driven by High-Cost Drugs

The PMPRB released its CompassRx 10th edition report showing Canadian public drug plan prescription spending grew 7.4% in 2022/23 to $14.1 billion from $13.2 billion in 2021/22. Over five years (2017/18 to 2022/23), total spending rose by $3.4 billion with a compound annual growth rate of 5.9%. Drugs costing over $10,000 annually were used by less than 3% of beneficiaries yet accounted for over one-third of total drug costs.

2024 PMPRB Annual Report Shows $22.1B Patented Medicine Sales

The Patented Medicine Prices Review Board (PMPRB) has tabled its 2024 Annual Report in Parliament. The report documents $22.1 billion in sales of patented medicines in Canada for the reporting period. PMPRB continues its role as Canada's federal board responsible for reviewing patented medicine prices to ensure they are not excessive.

Bernier 2009 FDA Regulatory Proceeding Citation

A 2009 FDA regulatory proceeding authored by Bernier has been cited and made available through the Regulations.gov docket system as part of a public filing (FDA-2026-P-3869-0069). The original document content is restricted due to copyright limitations. This reference represents an historical FDA regulatory proceeding that is being made accessible for regulatory record purposes.

Vessey 1986 Scientific Reference as FDA Background Material

A 1986 scientific reference authored by Vessey has been submitted as background material in connection with FDA submission FDA-2026-P-3869. This document provides supporting scientific context for the regulatory submission. The reference appears to be a peer-reviewed publication submitted to provide scientific support for safety or efficacy determinations in the associated FDA filing. No independent compliance obligations, deadlines, or enforcement actions are created by the submission of this reference document.

FDA Package Insert NDA 021323 Background Material

FDA has released background material supporting NDA 021323, which pertains to a package insert for a pharmaceutical product. The document was submitted through the FDA pre-market approval process and is part of the agency's review documentation. This background material is available for public access on Regulations.gov.

DC Emancipation Day 2026, District Services Modified

DC Department of Health announced modified District government services for DC Emancipation Day on Thursday, April 16, 2026. Low-barrier homeless shelters, mental health crisis services including the 988 helpline and DC Stabilization Center, select public libraries, and Department of Parks and Recreation outdoor facilities will remain open. No new compliance obligations are imposed.

Bard and Daig Steerable Diagnostic EP Catheter Recall for Sterility Breach

Health Canada issued a Type II recall for Bard Dynamic Deca Steerable Diagnostic EP Catheters (model 201101) and Daig Livewire Steerable Diagnostic EP Catheters (models 401904, 401575) due to breached sterile barriers on the chevron seal side of the primary Tyvek pouch. Stryker Sustainability Solutions received complaints reporting EP catheter devices with compromised sterile packaging. Affected lot numbers exceed 10; healthcare providers are advised to contact the manufacturer for specific lot information and next steps.

Medtronic SynchroMed Programmer Application Software Recall, Type II

Health Canada has issued a Type II recall for Medtronic's SynchroMed Clinician Programmer Application (CP app) model A810 due to a software sequencing issue affecting flex dosing programming for SynchroMed 8637 and 8667 infusion pumps. When flex dosing steps are added overlapping and out of chronological order, the app may fail to reorder them correctly, potentially causing infusion steps to be delivered at incorrect times, leading to missed doses, underdosing, or shifted dose timing without immediate alerts. Eleven complaints have been reported globally. Affected parties should contact Medtronic for information and guidance.

Nitrous Oxide Chargers: Sold for Inhalation Without Market Authorization (DIN) - Type I Recall

Health Canada has issued a Type I recall (RA-81896) for nitrous oxide (N2O) chargers sold by DOODLEZ, Gold Whip, and Whip-it! brands, all marketed for inhalation without market authorization (DIN). The recall affects flavored and unflavored gas chargers distributed by Mega Sphere Trading (Calgary, AB). Health Canada warns consumers not to inhale nitrous oxide products for recreational purposes due to serious health risks.

i-STAT EG7+ Cartridge Recall for pH Errors

Health Canada has issued a Type II recall for Abbott Point of Care Inc.'s i-STAT EG7+ Cartridge due to a manufacturing defect causing inaccurate pH and pCO2 readings. Affected lots (N25209, Model 03P76-25) may report higher than expected pCO2 and lower than expected pH results, potentially leading to inappropriate clinical interventions. Healthcare providers should immediately discontinue use of these cartridges for pH and pCO2 testing and contact the manufacturer for additional information.

Halozyme Hypercon Therapeutic Biologics Delivery Patent US12600763B2

USPTO granted patent US12600763B2 to Halozyme Hypercon, Inc. covering compositions and methods for delivering therapeutic biologics for disease treatment. The patent comprises 18 claims for particles containing therapeutic biologics suspended in a liquid carrier, with priority to an August 2022 filing date.

Tulane Patent for Therapeutic Compound Conjugates US12599674B2

The USPTO granted Patent US12599674B2 to The Administrators of the Tulane Educational Fund covering inventive therapeutic compound conjugates, pharmaceutical compositions, and related methods of treatment and manufacture. The patent, filed June 24, 2025, under application 19247100, contains 23 claims classified under A61K and A61P (oncology).

Jason Jimenez Surgical Assistant License Restricted

On April 2, 2026, the Texas Medical Board temporarily restricted the surgical assistant license of Jason Phillip Jimenez (Lic. No. SA00556) following his arrest on October 1, 2025, for one count of Aggravated Sexual Assault of a Child, a first-degree felony. The restriction is effective immediately and prohibits Mr. Jimenez from treating patients under 18 years of age and requires direct physician observation during all surgical assistant duties. The temporary restriction remains in place until further Board action.

TMB Restricts Austin Doctor for Inappropriate Text Messages

A disciplinary panel of the Texas Medical Board temporarily restricted, without notice, the Texas medical license of Dr. David Anthony Rodriguez (Lic. No. Q4504) effective April 8, 2026. The panel found Dr. Rodriguez engaged in repeated unprofessional conduct and sent a patient inappropriate and sexually explicit text messages. The restriction prohibits Dr. Rodriguez from practicing medicine on female patients, including via telemedicine. The temporary restriction remains in place until the Board takes further action.

Scabigard Suspension Class II Recall - Product Defect Affecting Efficacy

The UK Veterinary Medicines Directorate (VMD) has issued a Class II recall alert for Scabigard Suspension for Cutaneous Administration (Vm 42058/5173 and Vm 60021/3020) manufactured by Zoetis. The affected batches may fail to demonstrate expected signs of 'take' following administration. Nine batch numbers are affected, manufactured between June 2024 and January 2025, with expiry dates through December 2026. Wholesalers and veterinarians are required to immediately review inventory and quarantine affected products.

How MAHs Report Veterinary Medicine Defects

The UK Veterinary Medicines Directorate (VMD) has published guidance for Marketing Authorisation Holders (MAHs) on reporting product defects in veterinary medicines. MAHs must submit a completed Product defect report form to rapidalert@vmd.gov.uk and contact VMD to discuss recalls where a product or batch is likely to be recalled. The guidance also includes a table of recalled products from the last 12 months including recent recalls of Scabigard (April 2026), Hibiwash (March 2026), and Folltropin (November 2025).

Illegal Animal Medicines Seizures, Improvement Notices and Prosecutions

The Veterinary Medicines Directorate (VMD) publishes a rolling 12-month listing of enforcement actions under the Veterinary Medicines Regulations 2013 (VMR), including seizure notices, improvement notices, and prosecutions involving illegal animal medicines. The listing covers activities from August 2024 through April 2026, with updates added as enforcement actions occur. The VMD exercises powers of entry and inspector powers under the VMR to address non-compliance with animal medicine regulations.

VMD Published Standards 2025 to 2026: Monitoring Performance

The UK Veterinary Medicines Directorate (VMD) published its official statistics report monitoring performance against published standards for the period 2025 to 2026 up to 31 March 2026. The report includes monthly performance summaries from September 2025 through March 2026. This is an informational publication providing performance data rather than establishing new regulatory requirements.

Top Ten Imported Veterinary Medicines Quarterly Report Q1 2026

The UK Veterinary Medicines Directorate published its quarterly statistical report on certificates issued under the Special Import System for Q1 2026. Artuvetrin Therapy led with 3,256 certificates (27% of total), followed by Arthramid Vet with 1,346 certificates (11%). The top ten products collectively account for 58% of all certificates issued during the period. This is an informational report with no regulatory obligations or compliance requirements.

Renewed Women's Health Strategy Published by DHSC and NHS England

DHSC and NHS England have published the renewed Women's Health Strategy, announcing plans to improve women's healthcare experiences across England. Key initiatives include a trial linking women's feedback to provider funding, a single referral point to reduce waiting lists for conditions like endometriosis, and new standards for pain relief during gynaecological procedures. The strategy aims to address systemic issues where women's symptoms have been dismissed or inadequately treated.

MHRA Annual Accountability Review Minutes 2015 to 2025

The Department of Health and Social Care has published transparency data listing MHRA annual accountability review minutes from 2014-15 through 2024-25. The page was updated on 15 April 2026 to add the 2024-25 review minutes from 29 October 2025. No new compliance obligations are created by this administrative listing.

Renewed Women's Health Strategy for England

The DHSC has published the Renewed Women's Health Strategy for England, a 10-year plan outlining how the government will improve women's health and healthcare. The strategy aligns with the 10 Year Health Plan for England and aims to ensure women have voice, choice and power in their health and healthcare. The strategy was published on 15 April 2026.

Clinical Trial Setup Time Falls to 122 Days

DHSC announces that average setup time for commercial interventional clinical trials in the UK has fallen to 122 days, down from 169 days for the same period last year. The £137 million investment in health research reforms has streamlined processes and reduced bureaucracy. This progress advances the Prime Minister's commitment to get UK clinical trials up and running within 150 days by March 2026.

Donna Ockenden Appointed Chair of Independent Sussex Maternity Review

The UK Department of Health and Social Care has announced the appointment of Donna Ockenden as Chair of an independent review into Sussex maternity and neonatal services. Ockenden, known for leading the Shrewsbury and Telford NHS Trust review, was confirmed following direct engagement between the Health Secretary and bereaved families who campaigned for an independent review. The review is part of a government initiative to improve maternity safety across the NHS.

Diphtheria Cases Among Asylum Seekers England 2022 to 2026

UKHSA publishes statistical data tables showing confirmed toxigenic Corynebacterium diphtheriae cases among asylum seekers in England from 2022 to 2026. The publication is updated quarterly, with the most recent update adding January to March 2026 data. The next scheduled update is 2 July 2026.

Part 2A Health Protection Orders Transparency Data 2017-2025

UKHSA published anonymised transparency data summaries of statutory Part 2A health protection orders for financial years 2017-2018 through 2024-2025. Part 2A orders are statutory instruments used to protect public health through measures such as restricting movement, detaining individuals, and closing premises. The transparency data includes ODS format spreadsheet files for each financial year. No new compliance obligations are created for external parties.

NOIDs Causative Agents: Weekly Reports for 2026

UKHSA publishes weekly lab reports on notifiable diseases and causative agents for 2026. The data covers weeks 1 through 15 (January through April 2026) with separate HTML reports for each week. The list of reportable organisms has been expanded to include additional notifiable organisms under updated requirements. Affected parties should monitor these weekly publications as the reporting requirements may have been updated to include new organisms that laboratories must notify UKHSA about.

HIV Annual Data 2025: Testing, PrEP, New Diagnoses and Care Outcomes

UKHSA published annual HIV surveillance data for 2025 covering HIV testing, PrEP, PEP, new diagnoses, AIDS, deaths, and care outcomes across England, Wales, Northern Ireland, and Scotland. Data tables include demographic breakdowns, geographic region analysis, and key population statistics from 2015 to 2024. A slide set for presentational use is also available.

HIV and AIDS Reporting System: NHS Quarterly Data Collection Guidance

The UK Health Security Agency (UKHSA) updated its guidance on HIV surveillance systems, describing three reporting mechanisms: HARS (quarterly disaggregate data from NHS-funded HIV outpatient providers in England), HANDD (new diagnoses and deaths from laboratories and sexual health services), and CHARS (clinical data on children with HIV). Data from Scotland, Northern Ireland, and Wales is submitted annually and linked to create a UK-wide HIV database.

Mektovi (Binimetinib) 15mg and 45mg Dosage Confusion Safety Alert

ANSM issued a drug safety alert regarding Mektovi (binimetinib), an anticancer medication, following 7 reported medication errors from confusion between the 15mg and 45mg tablet dosages. The errors, which began after the 45mg dosage became available in July 2025, resulted in overdoses causing hepatocyte cytolysis, intense fatigue, nausea, serous retinal detachment, and elevated lipase levels. The recommended dose is 90mg/day (either 3 tablets of 15mg or 1 tablet of 45mg twice daily).

Emend 125mg Shortage, Alternative Treatments Proposed

ANSM published guidance on April 15, 2026 regarding the shortage of Emend 125mg (aprepitant) oral suspension manufactured by MSD. The drug, used in chemotherapy for children and infants aged 6 months to under 12 years, became unavailable at the end of March 2026 due to production problems. ANSM has arranged alternative supplies including Ivemend 150mg imports and authorized pharmacists to dispense magistral preparations without new prescriptions.

CMS LEAD ACO 10-Year Program Launching Jan 2027

CMS is launching the Long-term Enhanced ACO Design (LEAD) Model on January 1, 2027, replacing the ACO REACH Model. The 10-year voluntary program (2027-2036) offers two risk tracks: Global Risk Option (100% shared savings/losses with 1.75-3% benchmark discount) and Professional Risk Option (50% shared savings/losses). New payment flexibilities include capitated payments, advanced monthly payments, and a Non-Primary Care Capitation mechanism enabling specialist sub-capitation.

FDA Approves Extended EYLEA HD Dosing Interval for Wet AMD and DME

The FDA approved an extension of the maximum dosing interval for Regeneron's EYLEA HD (aflibercept) from 16 weeks to 20 weeks for patients with wet age-related macular degeneration (wAMD) and diabetic macular edema (DME). The approval is based on 96-week data from the PULSAR and PHOTON pivotal trials, which demonstrated that the majority of patients maintained visual and anatomic improvements with extended dosing intervals. The new regimen allows patients to be treated as infrequently as 2 to 3 times per year.

Congressional Investigations Quarterly: Healthcare Affordability, Drug Prices, Insurance in Q1 2026

Morrison & Foerster LLP published its Congressional Investigations Quarterly covering Q1 2026. The report examines congressional investigations into healthcare affordability, focusing on health insurance company CEO testimony on premium costs, pharmacy benefit manager (PBM) practices and prescription drug pricing, the 340B Drug Pricing Program, and vision care market consolidation. Additional investigations cover algorithmic pricing by technology platforms and college tuition pricing.

340B Drug Pricing Litigation Update Covers 50+ Cases

McDermott Plus published a weekly roundup of 340B drug pricing litigation covering more than 50 cases in federal and state courts for April 7–13, 2026. Key developments include the Fifth Circuit affirming denial of preliminary injunctions in Mississippi contract pharmacy cases, the Sixth Circuit staying a Tennessee case pending similar proceedings, a new drug manufacturer complaint challenging government audit enforcement and patient-definition determinations, and a trade association filing challenging a Washington state contract pharmacy law.

FCA Recoveries, HHS Cuts, OCR Investigations in Healthcare

Spilman Thomas & Battle's healthcare law newsletter covers record False Claims Act recoveries of $6.8 billion in fiscal year 2025, proposed HHS budget cuts, HHS Office for Civil Rights investigations of 13 states, Virginia medical malpractice developments, North Carolina hospital fee scrutiny, hospital bad debt increases, and FDA warnings to telehealth companies regarding GLP-1 product claims. The newsletter also reviews West Virginia legislative impacts on healthcare.

'We're Open for Business': OCR Enforcing Part 2 SUD Records; NPP Updates Required

The HHS Office for Civil Rights (OCR) has assumed enforcement authority over 42 CFR Part 2 (confidentiality of substance use disorder records) from the Department of Justice, effective Feb. 16, 2026. OCR Director Paula Stannard stated the agency is 'open for business' for Part 2 violations. Both covered entities (CEs) and Part 2 providers were required to update privacy notices by the compliance date, with Part 2 providers adopting HIPAA-like standards and CEs updating their Notice of Privacy Practices (NPPs) to address Part 2 records.

CMS FY 2027 IPPS Proposed Rule: 2.4% Payment Increase

CMS issued the FY 2027 IPPS proposed rule on April 10, 2026, proposing a 2.4% increase in operating payment rates for general acute care hospitals participating in the Hospital Inpatient Quality Reporting Program and meaningful EHR users, reflecting a 3.2% market basket increase less a 0.8% productivity adjustment. The proposed rule would nationalize the Comprehensive Care for Joint Replacement Model, require hospitals billing Medicare Part A and Part B to use CJR-X or TEAM for joint replacement episodes, eliminate the breakthrough device designation alternate pathway for new technology add-on payments, and make various MS-DRG changes.

CMS Targets Hospice Providers With Prepayment Reviews in Six States

CMS Medicare Administrative Contractors have been conducting expanded prepayment reviews (EPRs) of existing hospice providers since September 2024 in Arizona, California, Nevada, and Texas. As of December 2025, hospices in Georgia and Ohio have also been added to the review program. Husch Blackwell attorneys discuss how hospices can differentiate EPRs from other audit types, what to expect throughout the process, and strategies to overcome claim denials.

BDSI Loses Motion to Enforce Belbuca Injunction

The U.S. District Court for the District of Delaware denied BioDelivery Sciences International's July 2025 motion to enforce a 2022 final judgment and injunction against Alvogen regarding generic Belbuca (buprenorphine buccal film). The court found that Alvogen's new ANDA product was a reformulation with a more basic backing layer pH than the original ANDA product, and therefore not substantially identical to the enjoined product.

Benefits Brief: Responding to a HIPAA Breach of 25 Million Individuals - Conduent Incident

Vorys, Sater, Seymour and Pease LLP published guidance on the Conduent Business Services cybersecurity breach affecting approximately 25 million individuals, including over 15.4 million Texas residents, between October 21, 2024 and January 13, 2025. The article analyzes HIPAA obligations for covered entities and business associates when a third-party vendor experiences a breach of protected health information.

Missouri Expands Verified Dispensary Initiative with Billboards Radio Advertising

The Missouri Department of Health and Senior Services announced an expansion of its Verified Dispensary public outreach initiative, adding highway billboards at 218 locations and radio advertisements on 85 stations reaching approximately 1.5 million residents with over 5 million impressions. The campaign provides tools to help Missourians identify state-licensed cannabis dispensaries and includes an updated dispensary locator map.

Oregon City Measles Exposure Location at Legacy GoHealth

Oregon Health Authority and Clackamas County public health officials identified a measles exposure location at Legacy GoHealth in Oregon City. Individuals present at the clinic between 9:09 a.m. and 12:22 p.m. on April 10, 2026, or between 1:12 p.m. and 3:48 p.m. on April 11, 2026, should contact their healthcare provider. OHA warns against relying on news outlets for exposure information and directs the public to its official measles website for accurate listings.

Centennial Middle School Measles Exposure Date Added

Oregon Health Authority and Multnomah County public health officials have added an additional measles exposure date to Centennial Middle School in southeast Portland. The new exposure period is April 3, 2026, between 9:20 a.m. and 6 p.m. The complete exposure list includes April 1, 3, 6, 7, 8, 9, and 10. Officials urge anyone present during these times to contact their healthcare provider to determine measles immunity status.

Syphilis Rates Drop 18.6%, Congenital Syphilis Down 32.4% in New Mexico

The New Mexico Department of Health announced declines in sexually transmitted infection rates for 2025 compared to 2024. Syphilis rates dropped 18.6%, congenital syphilis fell 32.4%, chlamydia dropped 5.1%, and gonorrhea dropped 6.1%. NMDOH attributes the declines to expanded community outreach, increased testing and treatment, promotion of Doxy PEP post-exposure prevention medication, and partnerships with community, medical, and Tribal organizations.

Cyanobacteria Advisory Lifted at Scott Pond

The Rhode Island Department of Health has lifted the cyanobacteria advisory at Scott Pond. The advisory, which warned the public to avoid contact with the water due to potential harmful algal blooms, has been removed following testing that indicated cyanobacteria levels have returned to safe conditions.

Aerys Medical Bed Half-Rails Safety Recall by Winncare France

ANSM has published a safety alert regarding a field safety corrective action (FSCA No. R2610462) conducted by Winncare France for Aerys and Aerys Confort sliding medical bed half-rails. Users of the affected products have received direct correspondence from Winncare France. The alert is directed to pharmacies, community care facilities, retail establishments, and home health service providers.

Scientific Literature Reference Copyright Restricted

FDA published a document on regulations.gov (FDA-2026-P-3869-0004) regarding scientific literature references. The submission contains copyright-restricted content and is not fully accessible to the public. The document appears to be a regulatory submission or comment filed with FDA.

FDA Complaint FDA-2026-H-3943-0001

FDA received a complaint under docket FDA-2026-H-3943-0001 on April 15, 2025. The Center for Tobacco Products authored the complaint. The public comment period for this docket is now closed. No documents are available for viewing or download from the regulatory docket.