Healthcare & Life Sciences

Element Biosciences PCR-Free Library Preparation Patent Granted

The USPTO granted US Patent 12,606,819B2 to Element Biosciences, Inc. covering compositions and methods for PCR-free library preparation using double-stranded splint adaptors. The patent claims double-stranded splint adaptor structures with long and short hybridized strands carrying adaptor sequences, as well as one-pot multi-enzyme reaction workflows for introducing new adaptor sequences into library molecules. The patent contains 30 claims across CPC classifications including C12N 15/1065 and C12Q 1/6855.

Modified Cpf1 Guide RNA CRISPR Gene Editing Patent

The USPTO granted Patent US12606823B2 to inventor Kunwoo Lee covering a nucleic acid comprising a Cpf1 crRNA, a processing sequence 5′ of the Cpf1 crRNA, and an extension sequence 5′ of the processing sequence. The patent also covers compositions comprising the nucleic acid with a carrier and optionally Cpf1, as well as methods of genetically modifying eukaryotic target cells. The patent contains 29 claims and was filed on October 2, 2018.

Methods of Creating and Screening DNA-Encoded Libraries

The USPTO granted Patent US12606817B2 to X-Chem, Inc. (inventor: Richard W. Wagner) for methods of creating and screening DNA-encoded libraries for drug discovery applications. The patent contains 17 claims covering synthesis and screening methodologies that link functional moieties to initiator oligonucleotides for target binding identification. The filing date was June 19, 2020, with application number 16906626.

City of Hope AAV Bioreactor Patent US12606784B2

USPTO granted patent US12606784B2 to City of Hope for a cell cultivation apparatus and method for high-density cell growth and adeno-associated virus (AAV) production. The apparatus includes a membrane with surface features for cell placement, a gas-permeable material, and compartments configured to reduce media flow shear forces on cells. The patent names Colin Andrew Cook, Yuman Fong, Yu-Chong Tai, and Saswati Chatterjee as inventors.

UMass RPGR Gene Therapy Patent US12606825B2

The USPTO granted patent US12606825B2 to University of Massachusetts covering compositions and methods for modulating RPGR (retinitis pigmentosa GTPase regulator) expression for treating retinitis pigmentosa. The patent includes expression vectors encoding RPGR proteins and inhibitory nucleic acids targeting RPGRCONST isoforms. The application was filed on March 4, 2021, with 16 claims granted.

ENGINZYME AB Biocatalyst CPS Silica Patent US12606812B2

USPTO granted patent US12606812B2 to ENGINZYME AB on April 21, 2026, covering a biocatalyst composition for organic synthesis. The invention comprises controlled porosity silica (CPS) as support material with pore diameters between 20 and 100 nm, an amino-functionalized surface, and one or more immobilized catalytically active enzymes. The patent includes three claims and covers methods of manufacture and uses.

Tsinghua University Mirror Nucleic Acid Replication Patent

The USPTO granted Patent No. US12606808B2 to Tsinghua University for a method of replicating mirror nucleic acids. The patent covers reacting a mirror nucleic acid template, a mirror nucleic acid primer, and mirror dNTPs/rNTPs in the presence of a mirror nucleic acid polymerase. The patent contains 12 claims and was filed on May 31, 2022.

BASF SE Amylase Enzymes, Granted 21st Apr

The United States Patent and Trademark Office granted patent US12606809B2 to BASF SE on April 21, 2026. The patent covers genetically engineered amylase enzymes, compositions comprising the enzymes, and methods of making and using them. Applications include laundry detergents, dish washing detergents, cleaning products, baking, animal feed, pulp and paper processing, starch processing, brewing, and ethanol production. The application was filed on March 24, 2020, under application number 17442675.

US12606818B2: Illumina Granted, Nucleic Acid Sequencing Methods

The USPTO granted US Patent 12,606,818B2 to Illumina, Inc. on April 21, 2026. The patent covers methods and compositions for preparing nucleic acid templates and obtaining sequence data therefrom, with 29 claims. The application was filed on January 12, 2023.

US12606798B2 - Stem Cell Differentiation Methods and Compositions

USPTO granted US Patent 12606798B2 to Wisconsin Alumni Research Foundation covering methods and compositions for differentiating pluripotent stem cells into endothelial and hematopoietic lineages under defined conditions. The patent lists Igor Slukvin and Gene Ichiro Uenishi as inventors and contains 9 claims.

Effect of Motivational Interviewing on Cancer Fear and Cervical Cancer Screening in Rural Women

NIH registered ClinicalTrials.gov study NCT07540962, an interventional study examining the effect of motivational interviewing on cancer fear and participation in cervical cancer screenings among women living in rural areas. The study lists fear as the condition and motivational interview as the intervention.

Impact of Dog Adoption and Training in Veterans With Post-traumatic Stress Symptoms and/or Other Mental Health Conditions

NIH/NLM registered a single-arm clinical trial (NCT07542431) evaluating whether a dog adoption and training program can decrease posttraumatic stress symptoms, reduce stress, improve psychosocial health, and change biological markers (inflammation, oxytocin, brain structure/function) in veterans with self-reported PTSD or other mental health conditions. Participants attend eight one-hour professional dog training sessions within 10 weeks and visit a clinical research unit four times for data collection. The study carries no compliance obligations for external parties.

Guselkumab Persistence in UC and Crohn's Disease, Saudi Arabia

NIH registered ClinicalTrials.gov Study NCT07541261, an observational real-world study evaluating treatment persistence of guselkumab in participants with moderate to severe Crohn's disease or ulcerative colitis in Saudi Arabia. The study has no listed interventions and is classified as observational. Conditions studied include Colitis, Ulcerative and Crohn Disease.

Phase 3 RSVpreF Vaccine Trial, Japan, High-Risk Adults 18-59

NIH ClinicalTrials.gov has registered a Phase 3 study (NCT07543380) evaluating the immune response and safety of the RSVpreF vaccine in adults 18-59 years old who have health conditions placing them at increased risk of severe Respiratory Syncytial Virus disease. The study is being conducted in Japan, lasts approximately 2 months, and requires at least 2 site visits with a follow-up phone call 2 months after vaccination.

QCZ484 Phase 2 Extension Trial for Hypertensive Patients

The NIH has registered a Phase 2 open-label extension study (NCT07543120) for the drug candidate QCZ484 in hypertensive patients. The extension study is designed to collect additional safety and efficacy data from patients who successfully completed the parent study, CQCZ484A12201, or other QCZ484 studies as specified in respective parent protocols.

New Trial NCT07542912, Sintilimab Chidamide Azacitidine for ENKTL

A new open-label, single-arm, multi-center Phase II clinical trial (NCT07542912) has been registered on ClinicalTrials.gov, evaluating a sequential regimen of Sintilimab, Chidamide, and Azacitidine as first-line therapy for treatment-naïve patients with Stage I-II Extranodal NK/T-Cell Lymphoma (ENKTL). The study includes a Safety Lead-in Phase, a 2-cycle SCA Immunotherapy Induction Phase, and response-adapted consolidation therapy, followed by consolidative involved-field radiotherapy.

Breast and Cervical Cancer Awareness Training in Visually Impaired Women

This quasi-experimental clinical trial registration (NCT07541859) describes a study assessing whether a breast and cervical cancer awareness training program increases cancer screening participation among women with visual impairments. The study will also identify barriers to screening and evaluate improvements in cancer risk factor knowledge. Participants will receive training on cancer risk factors and screening methods, learn how to apply to the Cancer Early Diagnosis, Screening, and Training Center, and have their knowledge and screening status assessed at baseline, post-training, and three months later.

NIH Registers PMCF Study for Tears Naturale Eye Drops

NIH has registered a post-market clinical follow-up (PMCF) study (NCT07540884) evaluating the effectiveness and safety of Tears Naturale Free and Tears Naturale II lubricant eye drops in subjects with dry eye disease. The study will assess both products as lubricating eye drop interventions. This is a clinical trial registration entry on ClinicalTrials.gov, providing public access to study details and recruitment information.

PRL3-Zumab Phase 2 Trial, Advanced Solid Tumors, Multicenter

A multicenter, Phase II clinical trial (NCT07541001) of PRL3-zumab monotherapy has been registered for patients with unresectable or metastatic solid tumors. The open-label study uses a single dose level of 6 mg/kg administered via intravenous infusion every two weeks. The trial includes safety assessments, tumor evaluations per RECIST v1.1 and iRECIST, quality of life assessments, and survival follow-up.

Phase 2 Trial Comparing Methylprednisolone and Dexamethasone

NIH registered a Phase 2/III multicenter clinical trial (NCT07542288) comparing methylprednisolone (40-60 mg/day) and dexamethasone (8-12 mg/day) for treating peritumoral edema in brain metastasis patients during radiotherapy. The adaptive seamless design enrolls patients aged 18-75 with KPS scores of 40-80, beginning with 120 cases in stage II and expanding to up to 400 total cases in stage III. The primary endpoints are change in KPS score and incidence of grade 2 or higher hormone-related adverse reactions within one week after radiotherapy.

OCR Video Emphasizes Ongoing Risk Management Under HIPAA Security Rule

The Department of Health and Human Services' Office for Civil Rights released an educational video on risk management under the HIPAA Security Rule, emphasizing that risk management is mandatory, ongoing, and increasingly subject to enforcement scrutiny. OCR cited 2025 data showing approximately 76% of large reported HIPAA breaches resulted from hacking or IT incidents. The agency highlighted that entities identifying vulnerabilities but failing to implement corrective actions face exposure to findings of willful neglect and civil monetary penalties.

Final Rule Exempts ICHRAs and Account-Based Plans from Medicare Part D Notice

HHS published a final rule on April 6, 2026, formally excluding account-based group health plans from the Medicare Part D-creditable coverage notice requirement. The exclusion applies to individual coverage health reimbursement arrangements (ICHRAs), traditional HRAs, health care FSAs, HSAs, and other account-based plans. The rule, effective for coverage beginning January 1, 2027, adopts the November 2025 proposed rule without modification. HHS stated that requiring these plans to disclose creditable coverage status imposed an undue administrative burden and that dual messaging created confusing information for Part D-eligible individuals.

Nebraska LB 921 Enacts Mini-WARN Act and Healthcare Staffing Rules

Nebraska Legislative Bill 921 enacts two worker protection frameworks: the Nebraska WARN Act requiring 90-day advance notice of business closings and mass layoffs for employers with 100+ employees, and the Health Care Staffing Agency Registration Act mandating annual registration, prohibiting noncompete clauses, and imposing insurance requirements on healthcare staffing agencies. The Nebraska WARN Act provisions take effect July 2026; healthcare staffing provisions take effect July 2027. Both Acts include civil penalties and grant enforcement authority to the Nebraska Department of Labor.

IBM Pays $17M for Discriminatory DEI Practices

International Business Machines Corporation (IBM) agreed to pay $17,077,043 to resolve DOJ allegations that it violated the False Claims Act by failing to comply with anti-discrimination requirements in its federal contracts. The government alleged that IBM discriminated against employees and applicants based on race, color, national origin, or sex through tying bonus compensation to demographic targets, altering interview criteria through diverse interview slates, setting demographic goals for business units, and restricting access to certain training programs based on protected characteristics.

Federal Crackdown on Healthcare Fraud Waste and Abuse Intensifies

Congress and the Trump Administration have launched a coordinated crackdown on healthcare fraud, waste, and abuse. Key actions include an interagency federal task force, a six-month nationwide moratorium on Medicare enrollment for certain DMEPOS suppliers, and CMS deferral of approximately $259.5 million in federal Medicaid matching funds to Minnesota, with a warning that over $1 billion could be withheld if program integrity vulnerabilities are not remediated. CMS has also launched a CRUSH RFI seeking public input on expanding and strengthening fraud, waste, and abuse prevention efforts across federal healthcare programs.

HHS Secretary Testifies on FY 2027 Budget; Dr. Erica Schwartz Nominated CDC Director

Alston & Bird's weekly review summarizes HHS Secretary RFK Jr.'s congressional testimony on the FY 2027 budget request and President Trump's nomination of Dr. Erica Schwartz as CDC Director. The week also saw FDA publish multiple medical device classification rules and guidance documents across orthopedic devices, gene therapy, respirators, antibiotics, and testosterone replacement therapy.

Stark Law and False Claims Act Compliance in Physician Deals

Husch Blackwell LLP published a podcast episode discussing best practices for structuring physician compensation arrangements under Stark Law and False Claims Act requirements. The discussion covers compliance pitfalls in physician deals, including guidance on transparent compensation methodologies, risks of opaque 'black box' arrangements, and private equity investment considerations in healthcare.

DOJ's 2026 Corporate Enforcement Policy: Healthcare Self-Disclosure

Clark Hill analysis of DOJ's March 2026 Corporate Enforcement and Voluntary Self-Disclosure Policy, outlining how it intersects with existing healthcare disclosure frameworks including the 60-Day Overpayment Rule, CMS Self-Referral Disclosure Protocol, and OIG Self-Disclosure Protocol. The article describes four distinct disclosure pathways healthcare organizations must navigate and notes that disclosure timing is critical to preserve declination or penalty-reduction benefits.

CMS Proposes Sweeping Expansion of Health Care Interoperability and Prior Authorization Requirements

CMS published a proposed rule that would expand electronic prior authorization requirements to prescription drugs, shorten prior authorization decision timeframes, extend requirements to small group market QHP issuers on FF-SHOPs, require payer API endpoint reporting to CMS, and adopt FHIR as a HIPAA standard for prior authorization transactions for the first time. The rule also proposes Open Payments civil monetary penalties for entities that fail to provide audit documents within 30 calendar days, with a median per-record penalty of approximately $77,371.

FDA Reminds 2,200+ Companies Clinical Trial Disclosure Requirements

FDA issued reminder letters on March 30, 2026, to more than 2,200 medical product companies and researchers associated with over 3,000 clinical trials lacking required results submissions on ClinicalTrials.gov. The agency found that 29.6% of analyzed trials had not submitted results as mandated by FDAAA and the Final Rule at 42 C.F.R. Part 11. FDA stated it may issue Pre-Notices and Notices of Noncompliance if voluntary compliance is not achieved.

State AI Healthcare and Chatbot Laws: April 2026 Legislative Update

Troutman Pepper Locke published its 14th weekly tracking update on proposed state AI legislation for 2026. Nebraska enacted the Conversational AI Safety Act (signed April 14) and Maine enacted LD 2082 prohibiting unlicensed AI-delivered therapy or psychotherapy services (signed April 13). Multiple bills advanced in Iowa, Tennessee, Hawaii, Oklahoma, California, Arizona, Colorado, Louisiana, and Rhode Island, covering chatbots, AI pricing, provenance disclosures, employment, health, and personhood.

Federal Court Vacates Kennedy Declaration on Transgender Healthcare

The United States District Court for the District of Oregon granted summary judgment for 22 Plaintiff States and vacated the Kennedy Declaration in its entirety. The court found that HHS Secretary Kennedy lacked authority to unilaterally establish that transgender healthcare for minors falls below professionally recognized standards of care. The ruling permanently enjoins HHS and its Office of Inspector General from implementing the Kennedy Declaration or any materially similar policy against providers in the Plaintiff States.

Bioactive Phenolate Ionic Complexes, 21 Claims, US12606536B2

The USPTO granted Patent US12606536B2 to Yissum Research Development Company of the Hebrew University of Jerusalem Ltd. for bioactive phenolate ionic complexes. The patent covers isolated materials comprising phenolate species and counter ions in the form of metal salts, phosphonium, or ammonium. Twenty-one claims were allowed.

Process for Preparation of Apalutamide, Synthon B.V., Apr 21

The USPTO granted patent US12606539B2 to Synthon B.V. (a Dutch biopharmaceutical company) for a process to synthesize Apalutamide, along with its solid forms, salts, and solvates, and intermediates used therein. The patent application (18043777) was filed September 3, 2021, and carries 14 claims under CPC classifications C07D 401/04 and C07C 229/48. This grant gives Synthon B.V. exclusionary rights over this synthetic route for the prostate cancer drug.

Duk San Neolux Patent Granted, C07D Compound

The USPTO granted Patent US12610737B2 to DUK SAN NEOLUX CO., LTD. on April 21, 2026. The patent covers a compound of Formula 1 classified under C07D 251/24, designed for use in organic electronic elements. The invention aims to improve luminescence efficiency, stability, and lifespan of organic electronic elements.

L'OREAL Patent: C-Glycoside Keratin Treatment

USPTO granted Patent US12606534B2 to L'OREAL covering C-glycoside derivatives for cosmetic treatment of keratin materials including skin whitening, lightening, and depigmenting applications. The patent names Marie-céline Frantz, Maria Dalko, and Alexandre Cavezza as inventors with claims directed to compounds of formula (I) where R is as defined and S* is a mono or polysaccharide. The patent contains 6 claims and covers cosmetic compositions for non-therapeutic skin treatment uses.

Discectomy Tool Patent US12605178B2 Granted Apr 21

The USPTO granted Patent US12605178B2 to Combination Spine, Inc. for a discectomy tool designed to clear material from a patient's disc space. The device features dual rotatable members at the distal portion with a transverse axis, an actuation mechanism for rotation, and an expansion feature to increase inter-member distance. The patent names Joshua M. Ammerman and Richard Briganti as inventors and contains 29 claims.

Femoral Head Restoration Instrument, US12605170B2

The USPTO has granted Patent US12605170B2 to DePuy Ireland Unlimited Company. The patent covers a surgical instrument and method for assessing restoration of the femoral head centre during hip replacement surgery. The instrument comprises a body with a first connector for attaching to a femoral part, a plurality of apertures corresponding to respective femoral head centres, and a gauge with a pin and arm bearing a scale. The approach seeks to provide a simple method for restoring native femoral head position during hip replacement procedures.

Tactical Hemostatic Bandage Patent Granted to Solid Year Co

USPTO granted patent US12605164B2 to Solid Year Co., Ltd. on April 21, 2026, for a pressurized tourniquet comprising an elastic band, hemostatic dressing, and pressurized member. The invention features a through-tough on the outer surface of the elastic band and a detachable insertion portion on the pressurized member.

US12606640B2 - Recombinant Antimicrobial Polypeptide

The USPTO granted US Patent US12606640B2 to IRTA, Institut de Recerca i Transferència Agroalimentàries, covering a recombinant antimicrobial multidomain polypeptide comprising at least three peptidic domains — a non-enzymatic antimicrobial domain, a bacterial binding domain, and an enzymatic antimicrobial domain. The patent contains 21 claims and was filed on February 18, 2020.

Inhibitory T Cell Receptor Peptides and Discovery Methods

USPTO granted patent US12606816B2 to Janux Therapeutics, Inc. covering inhibitory T cell receptor peptides and methods of inhibiting T cell receptor interactions with peptide-major histocompatibility complexes. The patent discloses peptides that bind to T cell receptors without requiring major histocompatibility complex assistance. Six claims are associated with this patent.

Fish Totivirus Patent Granted to Pharmaq AS

The USPTO granted Patent US12606875B2 to Pharmaq AS on April 21, 2026, covering a novel fish Totivirus that causes mortality in fish and methods for detecting the virus. The patent names inventors Stian Nylund, Liv Sandlund, and Arnfinn L. Okland. The filing date was February 4, 2020, under Application No. 17433416, with 22 claims registered.

Method for Purifying Membrane Protein Complex - Sumitomo Patent US12606807B2

USPTO granted Patent US12606807B2 to Sumitomo Rubber Industries, Ltd. on April 21, 2026. The patent covers a method for purifying proteins derived from membrane protein complexes using synthetic polymers, antibodies, and pH-controlled elution with solvent extraction. The patent has 15 claims with a filing date of March 23, 2022.

Porous Silicon Nanoparticle Drug Delivery System with Reactive Oxygen Species Self-Activation, Kyung Hee University

The USPTO granted Patent US12605462B2 to the University-Industry Cooperation Group of Kyung Hee University for a porous silicon nanoparticle drug delivery system with isothiocyanate moiety conjugated to the surface. The invention generates reactive oxygen species in cells without an external initiator, promoting drug decomposition and release with low side effects due to high biocompatibility.

Regeneron Protein-Drug Conjugates Camptothecin Analogs Patent

The USPTO granted Regeneron Pharmaceuticals, Inc. Patent US12605459B2 covering protein-drug conjugates that combine camptothecin analogs with glutaminyl-modified antibodies for targeted therapeutic delivery. The patent describes methods for producing antibody-drug conjugates using transglutaminase and 1,3-cycloaddition techniques. The granted patent provides Regeneron exclusive rights to the disclosed compositions and methods, with two claims covering the conjugate structures and their therapeutic applications.

University of Minnesota Kinase Degradation Compounds for Cancer Treatment

USPTO granted Patent US12605452B2 to the Regents of the University of Minnesota on April 21, 2026. The patent covers compounds of Formula (I) or (II) comprising Aurora A or CDK4/6 ligands linked to E3 ligase ligands, along with pharmaceutical compositions and methods for treating cancer using such compounds. The patent contains 13 claims.

SYSTIMMUNE Antibody-Drug Conjugate Patent with Acidic Stabilization Junction

The USPTO granted Patent US12605458B2 to SYSTIMMUNE, Inc. on April 21, 2026, covering an antibody-drug conjugate with a hydrophilic acidic stabilization junction designed to maintain desired pharmacokinetic properties at higher drug loading. The patent, filed June 15, 2018, contains 18 claims and is classified under multiple therapeutic CPC codes including A61P 35/00 (anti-neoplastic), A61P 29/00 (anti-inflammatory), and A61P 37/02 (immunomodulators).

HIP1 Inhibitor Patent US12605456B2, Utah Valley University

The USPTO granted Patent US12605456B2 to Utah Valley University on April 21, 2026, covering inhibitor compounds that target the Huntingtin Interacting Protein 1 (HIP1) enzyme. The patented composition comprises a tripeptide targeting sequence directing the compound to HIP1's active site, conjugated to a C-terminal electrophilic warhead configured to inactivate the enzyme. The patent contains 20 claims.

US12605454B2 - Modified CMV VLPs as Vaccine Platform

USPTO granted Patent US12605454B2 to SAIBA AG for modified Cucumber Mosaic Virus (CMV) virus-like particles (VLPs) incorporating Th cell epitopes for enhanced immune responses as a vaccine platform. The 23-claim patent covers linking antigens to modified CMV VLPs to generate antibody responses. CPC classifications span infectious diseases, autoimmune conditions, metabolic disorders, and neurological applications. The patent application (17714307) was filed April 6, 2022.

Johns Hopkins Tolerogenic Antigen-Presenting Cell Patent US12605463B2

The USPTO granted patent US12605463B2 to Johns Hopkins University covering biodegradable particles designed to interact with immune cells and generate immunosuppressive effects. The particles include a polyester or polyester blend with soluble protein or small molecule encapsulated within, and two surface-attached protein types acting as Signal 1 and Signal 2 for immune cell binding and co-stimulation. The invention claims methods for inducing regulatory T cells and treating autoimmune diseases.