Healthcare & Life Sciences

Indoline Derivatives for Disease Treatment

The USPTO granted patent US12599584B2 to Yissum Research Development Company of The Hebrew University of Jerusalem Ltd. covering indoline derivatives and pharmaceutical compositions for treating diseases associated with oxidative stress, immune response, NO release, and pro-inflammatory cytokines. The patent names Marta Weinstock-Rosin, Abraham Nudelman, and Shani Zeeli as inventors and was filed on January 19, 2017. This grant establishes intellectual property protection for the therapeutic applications of these indoline compounds.

Pyrrole Compounds Patent - Aligos Therapeutics - US12599582B2

USPTO granted Patent US12599582B2 to Aligos Therapeutics covering pyrrole compounds of Formula (I), or pharmaceutically acceptable salts thereof, pharmaceutical compositions, and methods of treating diseases and conditions. The patent names inventors Sandrine Vendeville, David Bernard Smith, Leonid Beigelman, and Vladimir Serebryany. The application was filed August 22, 2023, with 2 claims granted.

Chlorinated Tetralin Compounds and Pharmaceutical Compositions

USPTO granted patent US12599587B2 to Springworks Therapeutics, Inc. on April 14, 2026. The patent covers chlorinated tetralin compounds and pharmaceutical compositions, classified under C07D 233/88 and A61K 31/417. The application (No. 18490993) was filed on October 20, 2023, and the granted patent contains 19 claims.

Bayer Aktiengesellschaft Substituted Isophthalic Acid Diamides Herbicide Patent, US12599136B2

The USPTO granted Patent US12599136B2 to Bayer Aktiengesellschaft covering substituted isophthalic acid diamides of general formula (I) for use as herbicides. The patent includes 15 claims covering compounds where X and Y are hydrogen, alkyl, or halogen radicals, and Z1 and Z2 are alkyl, cycloalkyl, or phenyl radicals with a heterocyclic Q ring. The patent was filed April 1, 2021, under Application No. 17995662.

Japan Science and Technology Agency V-ATPase Inhibitor Patent

USPTO granted patent US12599588B2 to Japan Science and Technology Agency for an inhibitor of Na+-translocating V-ATPase activity. The compound serves as an antibacterial agent and medicine with applications in antibacterial and screening methods. The patent application was filed January 15, 2020, contains 12 claims, and covers compounds with specific structural features including hydroxy, alkoxy, and amino substituents on phenyl groups.

Center for Tobacco Products Complaint, Apr 13, 2026

FDA Center for Tobacco Products (CTP) filed a complaint on April 13, 2026. The document is classified as closed in the Regulations.gov system (Docket FDA-2026-H-3804). The full complaint text is not available for public viewing on the regulatory portal. This appears to be a formal complaint related to tobacco product regulation.

BILTRICIDE Not Withdrawn for Safety or Effectiveness

FDA has determined under 21 CFR 314.161 that BILTRICIDE (praziquantel) oral tablet, 600 mg, was not withdrawn from sale for reasons of safety or effectiveness. The drug product, which was discontinued by Bayer Healthcare Pharmaceuticals in February 2024 and moved to the Orange Book's Discontinued Drug Product List, retains its eligibility for ANDA approvals. Novitium Pharma LLC submitted a citizen petition requesting this determination, which FDA granted based on review of Agency records.

FDA DMB Acknowledgment Letter to Hyman Phelps McNamara

FDA Division of Manufacturing and Quality (DMB) within CDER sent an acknowledgment letter to Hyman, Phelps & McNamara, P.C. in response to submission FDA-2026-P-4018. The acknowledgment indicates receipt of the submission without substantive review or determination at this stage. No regulatory obligations, compliance deadlines, or enforcement actions are imposed by this document.

Suitability Petition to FDA

Hyman, Phelps & McNamara, P.C. filed a Suitability Petition with the FDA under docket FDA-2026-P-4020-0001. The petition appears to request FDA approval for a drug product change under applicable administrative procedures. The filing was submitted to CDER for review.

FDA Suitability Petition, Comment Period Open

FDA Suitability Petition, Comment Period Open

Robeson County Behavioral Health Urgent Care Ribbon-Cutting Ceremony

North Carolina DHHS announces a ribbon-cutting ceremony for a new Behavioral Health Urgent Care facility in Robeson County on April 17, 2026. NCDHHS provided $2.2 million in funding as part of a historic mental health investment from the North Carolina General Assembly. This is the eighth of a planned 13 new or expanded BHUCs to open statewide.

MDHHS Encourages Syphilis Testing During STI Awareness Week; Cases Up 50%

MDHHS is urging Michigan residents to get tested for syphilis during STI Awareness Week (April 12-18) following a 50% increase in symptomatic and infectious syphilis cases over the past decade. Preliminary 2025 data show rising rates across all populations, including a record 58 congenital syphilis cases in 2024 — the highest in Michigan in over 30 years. The department recommends regular testing, early prenatal care with syphilis screening in the first and third trimesters, and consideration of doxycycline post-exposure prophylaxis (doxy PEP) for exposed individuals.

SC DPH Observes STI Awareness Week, Apr 12-18

SC DPH issued a press release observing National STI Awareness Week (April 12-18). The release presents 2024 data showing 81% of chlamydia cases and 66% of gonorrhea cases in South Carolina were diagnosed in people under 30. Congenital syphilis reached a record high of 44 cases in 2024. The agency emphasized the importance of prenatal care and syphilis screening for pregnant women.

Bed With Foot Warming System Patent Application

USPTO published patent application US20260096666A1 for a bed with integrated foot warming system. The application, filed November 4, 2025, covers a heating unit positioned inside an envelope at the foot of a bed, with power source and electrical connector. Inventors include Kody Lee Karschnik, Omid Sayadi, Wade Daniel Palashewski, Ramazan Demirli, Eric Rose, and Saurabh Chhaparwal.

FDA Reminds 2,200 Sponsors to Disclose Trial Results

The FDA sent messages on March 30, 2026, to more than 2,200 companies and researchers associated with over 3,000 registered clinical trials that do not appear to have submitted required results information to ClinicalTrials.gov. The agency seeks voluntary compliance before considering further regulatory action, including potential Pre-Notices and Notices of Noncompliance.

Phio Pharmaceuticals T Cell Induction Method for Cancer Treatment

USPTO published patent application US20260097120A1 assigned to Phio Pharmaceuticals Corp. The application covers methods for producing immunogenic compositions using ex vivo T cell treatment with oligonucleotide agents capable of controlling T cell differentiation through PD-1 silencing via chemically modified double-stranded nucleic acid molecules. The disclosed compositions and methods target cancer treatment, including melanoma.

Biallelic CIITA Knockout Patent, 34199 RNA Sequences

USPTO published patent application US20260097123A1 for compositions and methods for biallelic CIITA knockout using RNA molecules comprising guide sequences of 17-50 nucleotides. The application covers 34,199 sequences (SEQ ID NOs 1-34199). Inventor: Rafi Emmanuel. Filing date: September 19, 2023.

Biallelic Knockout CISH Gene, RNA Compositions

USPTO published patent application US20260097121A1 by inventor Rafi Emmanuel covering RNA compositions with guide sequences targeting the CISH gene for biallelic knockout. The application includes sequences defined by SEQ ID NOs 1-6838 and methods for their use. Filing date was September 18, 2023, under application number 19113098.

G47ΔhIL12A Oncolytic HSV for Glioblastoma and Triple-Negative Breast Cancer Treatment

USPTO published patent application US20260097135A1 for G47ΔhIL12A, an oncolytic herpes simplex virus (oHSV) engineered with human IL-12 transgene driven by HCMV IE enhancer/promoter. The invention addresses augmented transgene production and increased virus replication while maintaining safety profiles. Applications include treatment of glioblastoma (GBM) and triple-negative breast cancer (TNBC). Filing date: September 26, 2023; Application No. 19114912.

Patent for RSV vaccine using F protein trimer prefusion conformation

Patent for RSV vaccine using F protein trimer prefusion conformation

Controlled Movement Method for Gametes, Zygotes, Embryos

USPTO published patent application US20260098250A1 assigned to CIC nanoGUNE, filed September 6, 2023, covering a method and device for controlled movement of gametes, zygotes, and embryos using micro-scale carriers. The device comprises biocompatible carriers with maximum 500 μm dimensions that can releasably connect to biological cells and move autonomously or via external influences. The technology aims to enable less invasive procedures and higher implantation rates in reproductive medicine and healthcare applications.

EPA Draft CCL 6 Lists Microplastics and Pharmaceuticals as Priorities for Drinking Water

EPA issued its draft Sixth Contaminant Candidate List (CCL 6) under the Safe Drinking Water Act on April 6, 2026, marking the first time microplastics and pharmaceuticals have been designated as priority contaminant groups for evaluation. The draft list was published with a public comment period closing June 5, 2026. While CCL listing does not itself impose enforceable limits or obligations on water systems, it signals EPA's research and monitoring priorities for the coming decade.

Maine LD 2129 Bars Medical Debt Liens and Wage Seizure

Maine Governor Janet Mills signed LD 2129 into law on April 6, 2026, prohibiting medical debt collectors from placing liens on a consumer's principal residence or garnishing wages. The law also bars courts from enforcing wage garnishment orders based on medical debt and prohibits collection of interest on judgments related to liens or attachments on a debtor's principal residence. The legislation expands Maine's prior medical debt protections enacted under LD 558 in June 2025, which barred medical debt reporting to consumer reporting agencies. The law takes effect 90 days after adjournment of the current legislature's second regular session.

FDA Launches READI-Home Challenge for Home Medical Devices

FDA Launches READI-Home Challenge for Home Medical Devices

Ninth Circuit Finds First Amendment Right to Donate to Patient Assistance Charities, With Possible Impact on Anti-Kickback Statute Enforcement

The Ninth Circuit issued a published decision striking down California Assembly Bill 290 (AB 290) in full on First Amendment grounds, finding that Fresenius and other dialysis clinics have a protected constitutional right to donate to patient assistance charities that engage in expressive activity. The court held that donations driven by commercial self-interest remain constitutionally protected when made to expressive associations like the American Kidney Fund. While the case did not directly involve the federal Anti-Kickback Statute, the decision may call into question the constitutionality of AKS enforcement against pharmaceutical manufacturers making analogous donations.

Regulatory Overview: Post-Approval Changes to Marketed Drugs

Haynes Boone LLP published an overview of FDA reporting requirements for post-approval changes to approved New Drug Applications (NDAs). Drug sponsors must categorize proposed changes as major, moderate, or minor based on potential to affect drug product identity, strength, quality, purity, or potency. Major changes require FDA prior approval before implementation, moderate changes may be implemented 30 days after filing unless FDA objects, and minor changes are reported in annual reports.

Advertising Claim Substantiation Requirements for Health Products

Venable LLP published guidance on FTC and FDA substantiation requirements for health product advertising. The article explains that objective advertising claims for dietary supplements, foods, devices, and cosmetics must be supported by a 'reasonable basis' prior to making the claim. Health-related claims and structure/function claims require competent and reliable scientific evidence, with the specific level of evidence depending on the nature of the claim and what experts in the field would consider appropriate.

Health Care Week in Review: CMS CY 2027 MA Rate Announcement and FY 2027 IPPS/LTCH PPS Proposed Rule

Alston & Bird's weekly health care review summarizing CMS's finalized CY 2027 Medicare Advantage and Part D Rate Announcement and the proposed FY 2027 IPPS and LTCH PPS rule updating Medicare payment policies for inpatient and long-term care hospitals. The review also covers CDC's insufficient evidence finding on WTC Health Program petitions for hepatic steatosis, HHS/ACF's proposed rule to reduce burden for community services programs, and HRSA's funded extension for rural health care provider quality improvement programs.

Astellas Pharma Inc. v. Ascent Pharms., Inc. — District of Delaware Finds ANDA Infringement of Myrbetriq Patents

A Delaware federal court ruled in favor of Astellas Pharma in patent litigation concerning Myrbetriq (mirabegron extended-release tablets) used to treat overactive bladder. The court found that Ascent Pharmaceuticals' ANDA product infringed all asserted claims of the four patents-in-suit and rejected Ascent's defenses of non-infringement, invalidity based on Section 101 patent eligibility, anticipation, obviousness, and judicial estoppel. The court rejected Ascent's argument that its ANDA product's extended-release characteristics differed meaningfully from Myrbetriq.

Hilo Wellness Celebration Honors Health Volunteers and Mayors Health Challenge

The Hawaii Department of Health Hawaii District Health Office and the County of Hawaii Mayor's Office invite the public to a wellness celebration on April 24, 2026, from 11 a.m. to 2 p.m. at the Hilo State Building Lanai. The event marks the grand finale of National Public Health Week and National Volunteer Week, honoring health volunteers and continuing the Mayor's Health Challenge Legacy.

Indiana Urges Tick Precautions as Weather Warms

The Indiana Department of Health issued a public health advisory urging Hoosiers to protect themselves from tick bites as warmer weather increases tick activity across the state. The advisory follows the identification of Heartland virus in Indiana ticks and one human case in southern Indiana last year, indicating the presence of a new tick-borne disease in the state. Health officials recommend standard tick prevention measures through late fall.

Solid-State Storage of Biochemical Systems Patent Application

USPTO published patent application US20260098247A1 by inventor Javin Oza disclosing compositions and methods for solid-state storage of biological systems using polymeric cryoprotectants, saccharide cryoprotectants, emulsifiers, and lubricating flow agents, enabling cold chain-free, point-of-care platforms for diagnostics, research, biomanufacturing, and testing.

Ureteric Bud Kidney Tissue Engineering Compositions and Methods

The USPTO published patent application US20260098246A1 disclosing engineered ureteric bud kidney tissues and methods for making lumenized kidney tissues with spatially-controlled 3D tubular architecture. The application includes in vitro kidneys comprising nephron progenitor cells and ureteric bud cells. Inventors: Benjamin Shepherd, Alice Chen, J. William Higgins, III. Filed July 30, 2025.

Lipid-Encapsulated Dual-Cleaving Endonuclease for DNA and Gene Editing

USPTO published patent application US20260098248A1 for a lipid-encapsulated dual-cleaving endonuclease enabling non-viral gene editing methods, filed October 10, 2025 under application number 19355897. Inventors include David R. Edgell, Thomas A. McMurrough, Brent E. Stead, and Odisho K. Israel. The invention covers methods of administering a chimeric nuclease to cells or organisms without viral vectors.

Stem Cell Differentiation Method for Progenitor Cells and Organoids

The USPTO published patent application US20260098245A1 assigned to Koninklijke Nederlandse Akademie Van Wetenschappen (Royal Netherlands Academy of Arts and Sciences). The application, filed December 10, 2025, covers differentiation methods for progenitor cells including mammalian epithelial stem cells, differentiation media compositions for use in said methods, organoids and cells obtainable by said methods, and therapeutic uses thereof. Inventors are Johannes Carolus Clevers and Helmuth Gehart.

Methods for Producing Highly Purified (R)-3-Hydroxybutyl (R)-3-Hydroxybutyrate for Enhancing Bodily Function and Treating Disease States

USPTO published patent application US20260098281A1 by Romeo Tango, LLC for methods of producing highly purified (R)-3'-hydroxybutyl (R)-3'-hydroxybutyrate and biomedical uses thereof. The application covers therapeutic applications including inhibiting inflammasome activation, reducing pro-inflammatory cytokines, improving insulin sensitivity, enhancing mitochondrial biogenesis, and promoting muscle protein synthesis. Additional applications include improving cognitive function, reducing oxidative stress, enhancing cardiovascular health, and supporting neuroprotection.

Harvard Patent - Automated Parallel Chromatography for Extracellular Vesicle Purification

USPTO published patent application US20260098244A1 from President and Fellows of Harvard College disclosing devices and methods for automated parallel chromatography for purification of extracellular vesicles from biological samples. The invention includes a pump, computing device, and a stand with columns containing resin and bottom wells or tubes. CPC classifications indicate applications in cell/vesicle technology and chromatography methods.

Ultra-High Molecular Weight Xanthan Gum Engineered Strain and Detection Marker

The USPTO published patent application US20260098104A1 for an engineered bacterial strain that produces ultra-high molecular weight xanthan gum with molecular weight exceeding 2.0×10^7 Da, significantly above the ordinary range of 0.2×10^7-2.0×10^7 Da. The application also discloses a molecular marker for detecting the engineered strain and its processed products, enabling rapid identification in production and quality control contexts.

Novozymes A/S Patent for Enzymatic Plant Protein Extract Method

USPTO published patent application US20260096575A1 assigned to Novozymes A/S for an enzymatic method of producing plant protein extract. The method involves treating plant protein raw materials under alkaline conditions with protein deamidase added before, during, or after treatment, followed by protein recovery and spray drying. The resulting plant protein extract has improved solubility suitable for food or beverage applications. The application was filed on September 28, 2023.

Dura Mater-Derived Stem Cells and Method for Producing the Same

USPTO published patent application US20260098243A1 for dura mater-derived stem cells and production methods. Inventors: Sun Hwa PARK, Sung Won KIM, Seung Ho YANG, Jung Eun LEE, Hyun Ji LEE. The application, filed 2025-10-06 under Application No. 19350367, covers methods of isolating stem cells from dura mater with serum supplements and their use in cell therapeutic agents.

Alabama Issues First State Autism Spectrum Disorder Identification Card

Alabama's Department of Public Health announces the launch of the first state-recognized Autism Spectrum Disorder Identification Card in the United States. The cards are available at county health departments for $10 to Alabamians with an autism diagnosis verified by a healthcare provider. Cards help first responders and law enforcement understand and assist individuals during potentially stressful interactions.

OIG Advisory Opinion 25-11 Provides Discount Arrangement Guidance

OIG Advisory Opinion 25-11 Provides Discount Arrangement Guidance

DOJ Establishes National Fraud Enforcement Division to Target Healthcare and Taxpayer Programs

Acting Attorney General Todd Blanche issued a memorandum on April 7, 2026, formally establishing the National Fraud Enforcement Division within the DOJ. The Division will investigate and prosecute fraud against taxpayer-funded programs, including coordination with the 93 U.S. Attorney's Offices. Assistant Attorney General Colin McDonald assumed operational control of three existing Criminal Division units: the Tax Section, the Health Care Fraud Unit, and the Market, Government, and Consumer Fraud Unit.

Healthcare Digital Accessibility Deadline Is May 11

Holland & Knight LLP summarizes the Section 504 of the Rehabilitation Act of 1973 digital accessibility compliance deadline of May 11, 2026. Healthcare providers receiving federal financial assistance and employing more than 15 persons must ensure their websites, patient portals, telehealth platforms, mobile apps, and other digital health technology meet accessibility standards. HHS Office for Civil Rights enforces Section 504 violations through complaints and compliance reviews, potentially resulting in corrective action plans, penalties, suspension of federal funding, and referrals to the Department of Justice. Private parties may also bring federal court litigation seeking damages for discrimination.

CMS Urges DGA-Aligned Hospital Menus and Procurement Under Conditions of Participation

On March 30, 2026, CMS issued a Quality & Safety Special Alert Memo (QSSAM) to hospitals and Critical Access Hospital (CAH) providers titled 'Hospital Nutrition Service Obligations in Light of Updated Federal Nutrition Guidelines.' CMS links existing hospital Conditions of Participation (CoPs) at 42 C.F.R. § 482.28 to the Dietary Guidelines for Americans, 2025–2030 (DGAs), urging hospitals to review and revise food service policies, standard menus, therapeutic diet orders and food procurement practices to align with DGAs that limit ultra-processed foods and added sugars.

FDA Warning Letter DSCSA Violations at Aesthetics Clinic

The FDA issued a Warning Letter to Pure Indulgence Aesthetics on April 1, 2026, escalating from a December 2025 Form FDA 483 inspection that identified Drug Supply Chain Security Act violations. Key findings include discrepancies between Botox units purchased and administered, and an unlabeled botulinum neurotoxin vial found in the facility's trash. The company's inadequate response to the 483 — lacking concrete corrective actions, SOPs, or verification documentation — led to the Warning Letter escalation.

HIPAA Security Rule Proposed Updates Address Cyber Threats

The HHS Office for Civil Rights published a Proposed Rule on January 6, 2025, to update the HIPAA Security Rule in response to increased cyberattacks targeting ePHI. The proposed changes would eliminate the distinction between 'required' and 'addressable' specifications, mandate written security documentation, require technology asset inventories and network mapping, and impose multi-factor authentication and encryption requirements. The OCR has indicated finalization is expected in May 2026, with compliance likely required within 240 days of Federal Register publication, or early 2027.

Rhode Island Reports Decline in Sexually Transmitted Infection Cases

The Rhode Island Department of Health announced that sexually transmitted infection (STI) cases in the state have declined. This press release reports positive epidemiological data from the state's public health surveillance. No new regulatory requirements or compliance obligations are imposed on healthcare providers or the public.

Da Vinci X Xi Cannula Screw Safety Notice - Intuitive Surgical

ANSM has published a safety notice (Reference R2606328) informing French healthcare facilities about a safety action by Intuitive Surgical regarding cannula support screws on da Vinci X and Xi robotic surgical systems. Users have received direct communication from the manufacturer. Healthcare facilities with these systems should review the attached manufacturer letter for specific guidance.

Physio-Control/Stryker France DAE Electrode Kit Recall - Infant/Child Use

ANSM reports a safety recall by Physio-Control/Stryker France SAS for infant and child DAE (automated external defibrillator) electrode kits. Reference numbers R2607604/R2610482. Affected lots expired between August 2025 and January 2026. Hospital pharmacies, distributors, and operators holding these products should contact Stryker France directly for guidance.