Pharma &amp; Life Sciences — April 16, 2026

Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MRESVIA (Respiratory Syncytial Virus Vaccine)

FDA announces approval of MRESVIA (Respiratory Syncytial Virus Vaccine) and issuance of a Rare Pediatric Disease Priority Review Voucher under the voucher program established by the FDA Modernization Act of 2012. The approval was granted under Docket No. FDA-2026-N-3466 and published in 91 FR 20471 on April 16, 2026. This notice documents the completion of the regulatory review and voucher issuance for the vaccine product targeting RSV in pediatric populations.

Routine Notice Pharmaceuticals

Pharmacy Compounding Advisory Committee Meeting and Bulk Drug Substances Public Comment Request

The FDA announces a Pharmacy Compounding Advisory Committee meeting scheduled for July 23-24, 2026, and establishes a public docket (FDA-2025-N-6895) to receive comments on bulk drug substances nominated for inclusion on the Section 503A Bulk Drug Substances List. The agency seeks input from stakeholders on whether these nominated substances should be approved for use in pharmacy compounding.

Priority review Consultation Pharmaceuticals

AREXVY RSV Vaccine Approved for Rare Pediatric Disease Priority Review Voucher

The FDA granted a Rare Pediatric Disease Priority Review Voucher to AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) under Docket No. FDA-2026-N-3446. The voucher, published at 91 FR 20460, was awarded upon approval of the vaccine product.AREAS XVY is manufactured by GSK and is indicated for active immunization against RSV disease in adults 60 years and older, and in infants through maternal immunization.

Routine Notice Pharmaceuticals

MRESVIA RSV Vaccine Approval Under Material Threat Medical Countermeasure Priority Review Voucher

FDA approved MRESVIA (Respiratory Syncytial Virus Vaccine) using a Material Threat Medical Countermeasure Priority Review Voucher. The approval was announced via Federal Register Notice (Docket No. FDA-2026-N-3500, 91 FR 20467) on April 16, 2026. This action grants market authorization for the RSV vaccine, which was reviewed under an expedited pathway designed to encourage development of medical countermeasures addressing material public health threats.

Routine Notice Pharmaceuticals

MNEXSPIKE COVID-19 Vaccine Rare Pediatric Disease Priority Review Voucher Approval Notice

FDA issued a Notice announcing approval of MNEXSPIKE, an mRNA COVID-19 vaccine, under the Rare Pediatric Disease Priority Review Voucher program. The voucher program incentivizes development of treatments for rare pediatric diseases by providing priority review vouchers that can be used for future FDA review requests. Docket No. FDA-2026-N-3447.

Routine Notice Public Health

1d ago • DEA Press Releases

DEA Addresses Drug Threats, Pharmacy Crime at Diversion Summit

DEA Assistant Administrator Cheri Oz addressed emerging drug threats, pharmacy crime, and prescription drug misuse at the National Association of Drug Diversion Investigators Rx Diversion Summit in Covington, KY. The remarks targeted over 300 pharmacists, investigators, and hospital leaders on controlled substance enforcement priorities.

Routine Notice Pharmaceuticals

1d ago • MHRA Publications

Single-dose 7.2mg Semaglutide (Wegovy) Pen Approved for Adult Obesity

The MHRA approved a new single-dose 7.2mg semaglutide (Wegovy) pen for adult patients with obesity (BMI ≥30kg/m²). The approval consolidates the maximum weekly dose into one injection rather than three separate 2.4mg doses. Starting dose is 0.25mg weekly, gradually increasing every four weeks as prescribed. The agency will continue monitoring safety and effectiveness.

Routine Notice Pharmaceuticals

1d ago • EPO Patent Bulletin - Biotech (C12N)

Synthetic CAR-T Cells for Treating IL13Ra2 Positive Human and Canine Tumors

The European Patent Office published patent application EP4021464A1 (A1 kind, April 8, 2026) for synthetic CAR-T cells targeting IL13Ra2 positive tumors in humans and canines. Applicant is The Trustees of The University of Pennsylvania. Inventors include O'ROURKE, Donald M., YIN, Yibo, JOHNSON, Laura, BINDER, Zev, and THOKALA, Radhika. The patent covers compositions and methods for treating IL13Ra2-positive tumors using synthetic chimeric antigen receptor T-cells.

Routine Notice Intellectual Property

1d ago • EPO Patent Bulletin - Biotech (C12N)

Gene Therapy for Alzheimer's Disease - Brigham and Women's Hospital EP3976637

The European Patent Office published patent application EP3976637A1, filed by The Brigham and Women's Hospital, Inc. and The General Hospital Corporation, covering a gene therapy approach for treating Alzheimer's disease. The invention, developed by inventors Shen Jie and Kelleher III Raymond J., is classified under C12N 15/86 and related protein classification C07K 14/47. The patent is designated across all EU member states including AL, AT, BE, BG, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LI, LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, and TR.

Routine Rule Intellectual Property

1d ago • FR: Health and Human Services Department

SAMHSA Proposes PAIMI Program Performance Report Data Collection Under PRA

SAMHSA published a 60-Day Notice in the Federal Register seeking public comment on information collection activities for the Protection and Advocacy for Individuals with Mental Illness (PAIMI) Revised Annual Program Performance Report (PPR). The notice requests comments on whether the proposed data collection is necessary, accurate, and minimally burdensome. The OMB clearance for the current 2024-2025 PPR expires July 31, 2026, and SAMHSA is seeking approval for updates to the reporting requirements.

Routine Notice Public Health

1d ago • FR: Health and Human Services Department

VICH GL8(R1) Draft Guidance: Stability Testing for Medicated Premixes (Revision 1)

The FDA announced availability of draft guidance for industry GFI #91 (VICH GL8(R1)) on stability testing for medicated premixes for veterinary use. Developed through the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH), this revision updates recommendations for stability testing of medicated premixes intended for oral administration following incorporation into animal feed. The draft is open for public comment until June 15, 2026.

Routine Notice Pharmaceuticals

1d ago • FR: Health and Human Services Department

Importation of Prescription Drugs Comment Request

The FDA has published a notice in the Federal Register announcing an opportunity for public comment on a proposed information collection related to the importation of prescription drugs. Under the Paperwork Reduction Act, the Agency seeks public input on existing information collection requirements. The comment period closes on June 15, 2026.

Routine Notice Pharmaceuticals

1d ago • FR: Centers for Medicare & Medicaid Services

Medicare IPPS FY 2027 Correction: Comment Deadline Changed from April 10 to June 9, 2026

CMS issued a correction to a previously published proposed rule for Medicare IPPS FY 2027. The correction fixes a typographical error in the DATES section, changing the public comment deadline from April 10, 2026 to June 9, 2026. The correction applies to the proposed rule published April 14, 2026 (FR Doc. 2026-07203, 91 FR 19312).

Routine Notice Healthcare

1d ago • FR: Centers for Medicare & Medicaid Services

Agency Information Collection Activities: Submission for OMB Review; Comment Request

The Centers for Medicare and Medicaid Services (CMS) has published a notice under the Paperwork Reduction Act of 1995 announcing an opportunity for public comment on proposed information collections identified as CMS-10712 and CMS-10266. The notice invites interested persons to submit comments on the burden estimates and aspects of these proposed collections to the Office of Management and Budget (OMB). Comments must be received by May 18, 2026.

Routine Notice Healthcare

1d ago • FR: Centers for Medicare & Medicaid Services

Medicaid and CHIP Generic Information Collection Activities: Proposed Collection; Comment Request

CMS published a Federal Register notice seeking public comment on generic information collection activities under OMB control number 0938-1148 (CMS-10398). The collections relate to Medicaid and CHIP State plan amendments, waivers, demonstrations, and reporting under a generic clearance process approved by OMB. Comments must be received by April 30, 2026.

Routine Consultation Healthcare

1d ago • FDA Warning Letters

Online Rx Medz Warning Letter - Unapproved Opioids, Benzodiazepines, and Stimulants

FDA issued a Warning Letter to Online Rx Medz (www.onlinerxmedz.com) for introducing unapproved and misbranded drugs into interstate commerce in violation of the FD&C Act. The observed violations involve opioids, benzodiazepines, and Schedule II stimulants. FDA requests the company immediately cease offering any unapproved and misbranded drugs for sale to U.S. consumers.

Urgent Enforcement Pharmaceuticals

1d ago • FDA Warning Letters

Rxgoodusa Warning Letter Unapproved Opioids Benzodiazepines Internet Sales

FDA issued a Warning Letter to Rxgoodusa (www.rxgoodusa.com) for introducing unapproved new drugs and misbranded drugs into interstate commerce in violation of the FD&C Act. The violations involve opioids and benzodiazepines sold online without required FDA approval. This is the company's second Warning Letter, having received a prior letter in August 2025 while operating under www.usaquickmeds.com. FDA requests immediate cessation of sales of all unapproved and misbranded drugs.

Priority review Enforcement Pharmaceuticals

1d ago • FDA Warning Letters

Beauty of Aztlan LLC, Unapproved Drug Violations

FDA issued a Warning Letter to Beauty of Aztlan LLC for introducing unapproved new drugs into interstate commerce via their website www.beautyofaztlan.squarespace.com. The violations involve injectable botulinum toxin products marketed as "Botulax 100units" and "Innotox 50units" without FDA-approved applications, in violation of sections 301(d) and 505(a) of the FD&C Act. FDA requests the company immediately cease offering any unapproved and misbranded drugs for sale to U.S. consumers.

Priority review Enforcement Pharmaceuticals

1d ago • FDA Warning Letters

Smart Vending Services LLC - Nicotine Pouch Marketing Violation Warning

The FDA Center for Tobacco Products issued a Warning Letter to Smart Vending Services, LLC (Henderson, NV) for marketing new nicotine pouch products, including HYPPE Wintergreen 8 mg, without required premarket authorization under section 910 of the FD&C Act. FDA determined the products are adulterated under section 902(6)(A) and misbranded under section 903(a)(6) for failure to provide required premarket reports. The firm is required to ensure all tobacco products it sells or distributes have proper FDA marketing authorization or face enforcement action.

Priority review Enforcement Consumer Protection

1d ago • FDA Warning Letters

Chemco Corp Warning Letter - CGMP and Drug Violations

The FDA issued Warning Letter 320-26-60 to Chemco Corporation on April 7, 2026, citing significant violations found during an August 11-22, 2025 inspection of their drug manufacturing facility in Miami Lakes, FL (FEI 1042599). Investigators identified CGMP violations including inadequate equipment cleaning and lack of cleaning validation studies for non-dedicated equipment. The firm also distributed unapproved new drugs and misbranded drug products including PRO Nail FUNGUS KILLER and multiple Eternal Spirit Beauty and SPA REDI products.

Priority review Enforcement Pharmaceuticals

1d ago • FDA Warning Letters

Purolea Cosmetics Lab CGMP Violations Warning Letter 320-26-58

FDA issued Warning Letter 320-26-58 to Purolea Cosmetics Lab (FEI 3011669383) in Livonia, MI, citing CGMP violations and insanitary conditions found during an October 2025 inspection. Investigators observed insects, filth, leaves, and clutter in manufacturing areas, and inadequate separation from outside contamination. The firm failed to conduct required microbiological testing on drug batches before release. Two products, Dermveda Extra Strength Shingles Relief and Dermveda Extra Strength Ultra Genital Herpes Relief, are flagged as unapproved new drugs intended to treat serious conditions.

Urgent Enforcement Pharmaceuticals

1d ago • FDA Warning Letters

Dry Springs Pharmacy Warning Letter - Unapproved Opioids, Benzodiazepines, and Schedule II Stimulants

FDA issued a warning letter to Dry Springs Pharmacy (dryspringspharmacy.net) for introducing unapproved and misbranded opioids, benzodiazepines, and Schedule II stimulants into interstate commerce in violation of the FD&C Act. The agency found the website markets drugs that circumvent regulatory safeguards, posing significant public health risks given the ongoing opioid epidemic and benzodiazepine nonmedical use crisis. FDA has requested the pharmacy immediately cease offering these unapproved drugs for sale to U.S. consumers.

Urgent Enforcement Pharmaceuticals

Determination That CHEWTADZY (Tadalafil) Chewable Tablets Were Not Withdrawn From Sale for Safety or Effectiveness

FDA determined that CHEWTADZY (tadalafil) chewable tablets, 5 mg, 10 mg, and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination removes a statutory barrier and allows FDA to approve abbreviated new drug applications (ANDAs) for generic versions of the drug product if all other legal and regulatory requirements are met. The drug is subject of NDA 218527, held by B Better, LLC, which was initially approved on June 28, 2024.

Routine Notice Pharmaceuticals

New Animal Drug Applications - Approval and Withdrawal Actions (Oct-Dec 2025)

FDA issued a final rule amending animal drug regulations to reflect application-related actions for NADAs, ANADAs, and CNADAs during October, November, and December 2025. The rule includes approval of original and supplemental applications, conditional approvals, sponsor changes, sponsor address changes, and withdrawal of approvals. Affected parties include sponsors and manufacturers of animal drug products. The rule is effective April 16, 2026.

Routine Rule Pharmaceuticals

REVIA Naltrexone 50mg Tablets Not Withdrawn for Safety Determination

FDA has determined that REVIA (naltrexone hydrochloride) tablets, 50mg, was not withdrawn from sale for reasons of safety or effectiveness. The drug, originally approved November 20, 1984, under NDA 018932 held by Teva Women's Health, Inc., was subject to a withdrawal request dated May 16, 2018. This determination permits FDA to continue approving abbreviated new drug applications (ANDAs) that refer to this listed drug product.

Routine Notice Pharmaceuticals

FDA Determines Regulatory Review Period for UNLOXCYT Patent Extension

Routine Notice

Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs

The FDA is announcing an opportunity for public comment on a proposed information collection associated with orphan drug requirements under the Paperwork Reduction Act of 1995. The Agency seeks input on existing collection requirements related to orphan drug designation. Comments must be submitted by June 15, 2026.

Routine Notice Pharmaceuticals

1d ago • FR: National Institutes of Health

Center for Scientific Review Notice of Closed Meetings

The National Institutes of Health Center for Scientific Review announces five closed virtual meetings scheduled for May 13-14, 2026. The meetings will review and evaluate grant applications and contract proposals for programs including Behavioral Neuroscience training, the REDS Program Brazil Field Center, Transfusion Laboratory Studies, and Research Enhancement Award programs. Meetings are closed pursuant to the Federal Advisory Committee Act to protect confidential trade secrets, commercial property, and personal information.

Routine Notice Government Contracting

TLR4 Antagonist Patent for Multiple Myeloma Treatment EP3558323A1

The European Patent Office granted patent EP3558323A1 for specific TLR4 antagonists in the treatment of multiple myeloma. The patent applicants include Etablissement Français du Sang, CNRS, Université Paul Sabatier Toulouse III, and INSERM. Designated states cover all EU member states plus other EPC contracting states.

Routine Rule Intellectual Property

Novel Recombinant Protein UK114 in Stable Polymer Form for Tumour Treatment

The European Patent Office granted Patent EP3554639A1 to Alberto Bartorelli Cusani for a novel recombinant protein UK114 in stable polymer form designed for the treatment or prevention of malignant solid and systemic tumours. The patent covers pharmaceutical compositions containing the recombinant protein and methods of treatment. The patent is classified under A61K 38/50 and related pharmaceutical categories.

Routine Rule Intellectual Property

Bispecific Anti-TRAILR2 and Anti-CDH17 Binding Molecules for Cancer Treatment - EP3559040A2

The EPO published patent application EP3559040A2, filed by Boehringer Ingelheim International GmbH, covering bispecific binding molecules that simultaneously target TRAILR2 (TNF-related apoptosis-inducing ligand receptor 2) and CDH17 (cadherin 17) for the treatment of cancer. The patent application was published on April 8, 2026 and is classified under IPC categories C07K 16/28, A61K 39/395, A61P 35/00, and C12N 15/62. The application designates all EPO contracting states covering major European pharmaceutical markets.

Routine Notice Intellectual Property

Polyglutamated Antifolates and Uses Thereof (EP3496757A1)

The European Patent Office published patent application EP3496757A1 for polyglutamated antifolates and their therapeutic uses, filed by L.E.A.F Holdings Group LLC. The patent covers compositions for treating cancer and inflammatory conditions. The application was published April 8, 2026, designating 36 European states including Germany, France, the United Kingdom, Italy, Spain, and other EU member states. No compliance deadlines or penalties are specified.

Routine Notice Intellectual Property

Fibrous Dosage Form EP3500242A1

The European Patent Office published patent application EP3500242A1 titled 'Fibrous Dosage Form' on April 8, 2026. The patent application, filed by applicant Aron H. Blaesi with inventors Blaesi and Nannaji Saka, covers pharmaceutical dosage formulations classified under IPC A61K. The application designates multiple European member states for patent protection.

Routine Rule Intellectual Property

EP3283091A1 - Berry Extraction Method Using Alkaline Magnesium Compound

The European Patent Office granted Patent EP3283091A1 to inventor Reijonen, Mika Tapio. The patent covers a method of extracting berries or fruits using an alkaline magnesium compound for use in pharmaceutical, herbal, nutritional, or cosmetic ingredients. The patent is valid in 38 designated European states.

Routine Rule Intellectual Property

PHARMACEUTICAL COMPOSITIONS COMPRISING POH DERIVATIVES

The European Patent Office granted Patent EP3244930A1 to the University of Southern California on April 8, 2026. The patent covers pharmaceutical compositions comprising POH derivatives for therapeutic applications including cancer treatment. The patent is designated across 38 European member states including DE, FR, GB, IT, ES, NL, BE, and others.

Routine Rule Intellectual Property

Bi-Specific Cancer Treatment Constructs with Different Epitope Binding

The European Patent Office published patent application EP3484516A1 assigned to Fred Hutchinson Cancer Center on April 8, 2026. The patent covers bi-specific binding domain constructs with different epitope binding properties for treating cancer. The technology falls under IPC classifications A61K 39/395, C07K 16/28, and C12N 15/09, with designated states covering major European markets.

Priority review Rule Intellectual Property

Immunoglobulin antibody against RSV prefusion F protein, published 8th Apr

Routine Notice

1d ago • USPTO Patent Grants - Biotech (C12N)

Oligonucleotides for Inducing Paternal UBE3A Expression - Angelman Syndrome Treatment

USPTO granted patent US12596118B2 to Hoffmann-La Roche Inc. covering oligonucleotides capable of inducing expression of ubiquitin-protein ligase E3A (UBE3A) from the paternal allele for treatment of Angelman syndrome. The 30 claims target the suppressor of the UBE3A paternal allele via hybridization to SNHG14 long non-coding RNA downstream of SNORD109B.

Routine Notice Intellectual Property

EP3759090A1 Novel Therapeutic Compounds by Inflazome Limited

The European Patent Office published patent application EP3759090A1 for novel therapeutic compounds filed by Inflazome Limited. The patent covers heterocyclic compounds with IPC classifications including C07D derivatives and A61P therapeutic activity (anti-inflammatory/analgesic). Designated states include all EU member states plus associated countries. The publication marks the grant of patent rights for these novel compounds.

Routine Rule Intellectual Property

Use of Chimeric Antigen Receptor-Modified T Cells to Treat Cancer

The European Patent Office granted Patent EP3660029A1 to The Trustees of the University of Pennsylvania covering chimeric antigen receptor (CAR)-modified T cells for cancer treatment. The patent names inventors Carl H. June, Bruce L. Levine, David L. Porter, Michael D. Kalos, and Michael C. Milone. The patent covers methods for treating cancer using CAR-modified T cells, with designations extending across 35 European states.

Routine Rule Intellectual Property

Methods for Using Low-Dose Colchicine After Myocardial Infarction (EP3821909A1)

The European Patent Office published application EP3821909A1, titled 'Methods for Using Low-Dose Colchicine After Myocardial Infarction.' The application, filed by Institut de Cardiologie de Montréal, claims methods of treating patients with low-dose colchicine following myocardial infarction. The published application covers 38 designated European states.

Routine Rule Intellectual Property

INHIBITORS OF TRPC6 - Boehringer Ingelheim International GmbH

The European Patent Office published patent application EP3752503A1 for TRPC6 inhibitors assigned to Boehringer Ingelheim International GmbH. The patent covers therapeutic compounds for cardiovascular, respiratory, and neurological applications. The application designates all EPC contracting states including Germany, France, United Kingdom, Italy, and Spain.

Routine Notice Intellectual Property

Novel Anti-inflammatory Compounds - EP3759089A1

The European Patent Office published patent application EP3759089A1 for novel anti-inflammatory compounds developed by Inflazome Limited. The patent covers compounds classified under C07D 401/12 with therapeutic applications (A61P 29/00). Validated in designated contracting states including Germany, France, United Kingdom, Italy, Spain, and other EU member states.

Routine Notice Intellectual Property

1d ago • FR: Health Resources and Services Administration

TPEC Program Performance Measures Information Collection Request

HRSA announced a proposed Information Collection Request under the Paperwork Reduction Act for the Transforming Pediatrics for Early Childhood (TPEC) Program Performance Measures. The collection would require TPEC funding recipients to report standardized annual performance measures demonstrating program impact on young children and families served by TPEC-funded pediatric practices. Public comments on the burden estimate and other aspects of the collection are requested by June 15, 2026.

Routine Notice Healthcare

1d ago • TGA Australia Safety Alerts

Artri Ajo King Tablets Contain Undeclared Prescription Medicines

TGA Laboratory testing identified Artri Ajo King tablets as containing undeclared diclofenac and dexamethasone, both prescription-only medicines in Australia. The TGA has issued a safety advisory warning consumers to stop using the product and is coordinating with the Australian Border Force to seize and destroy shipments at the border. Supply of these products without declared prescription medicines is illegal under Australian therapeutic goods legislation.

Urgent Enforcement Pharmaceuticals

2d ago • Swissmedic Health Professional Communications

Spevigo Authorization Transfer to LEO, Delayed Leaflet

Swissmedic notifies healthcare professionals that the marketing authorization for Spevigo (spesolimabum, authorization no. 68625) was transferred from Boehringer Ingelheim (Schweiz) GmbH to LEO Pharmaceutical Products Sarath Ltd. effective 02.03.2026. To prevent supply disruption, packages with outdated package leaflets remain in circulation until the reprint is completed. These leaflets have not yet been updated with the latest approved safety information.

Routine Notice Pharmaceuticals

1d ago • FDA Medical Device Recalls

Stryker Updates Use Instructions for Patient-Fitted TMJ Reconstruction Prostheses

Stryker issued an urgent medical device correction for TMJ Unilateral and Bilateral Implants (catalogs CHG010, CHG024, CHG031, CHG020, CHG026, CHG032). The FDA identified this as the most serious recall type due to screw hole positioning discrepancies that may cause recommended screw lengths to exceed bone thickness, risking cranial vault penetration. One serious injury has been reported. Healthcare providers should continue monitoring patients per follow-up protocols and contact Stryker if affected devices remain in unused inventory.

Urgent Enforcement Medical Devices

1d ago • FDA Medical Device Recalls

Correction for Philips Trilogy Evo Platform Ventilators - Non-Pneumatic Nebulizer Restrictions

FDA issued a Class I recall for Philips Trilogy Evo Platform ventilators (models DS2110X11B, DS2200X11B, DS2100X11B, DS2000X11B) due to risks from non-pneumatic nebulizer use causing tidal volume discrepancies and potential therapy under-delivery. Affected parties must update all devices to software version 1.05.15.00 and stop all use of non-pneumatic nebulizers. Failure to correct devices may result in serious injury or death.

Urgent Enforcement Medical Devices

1d ago • HSA Singapore Announcements

New Drug Approvals February 2026

The Health Sciences Authority (HSA) Singapore announced new therapeutic product approvals granted in February 2026. The announcement lists newly approved therapeutic products and new indications approved for registered therapeutic products. Healthcare professionals and industry members are directed to the listing for details.

Routine Notice Pharmaceuticals

1d ago • HSA Singapore Announcements

Welcome Speech at 80th Anniversary of National Blood Programme

HSA CEO Adj Prof (Dr) Raymond Chua delivered a welcome speech at the 80th anniversary of Singapore's National Blood Programme. The speech recognises donors, partners, and volunteers who have contributed to the programme since its establishment, as well as the ongoing partnership with the Singapore Red Cross. HSA's Blood Services Group and laboratory staff are commended for maintaining internationally recognised standards in transfusion medicine.

Routine Notice Public Health

1d ago • HSA Singapore Announcements

Singapore National Blood Programme Marks 80 Years

The Health Sciences Authority (HSA) and Singapore Red Cross marked the 80th anniversary of the National Blood Programme at a commemorative event. Minister for Health Ong Ye Kung announced new donor recognition initiatives including a Healthpoints programme launching in H2 2026 and the '80 for 80' Blood Donation Marathon to encourage corporate blood donation drives. HSA projects Singapore's blood demand could outstrip supply by 2035 as youth donations have declined by more than half over the past decade.

Routine Notice Public Health

Artificial Sweat Composition, EP3355853A1, Apr 08

Routine Notice

Cinnamyl Alcohol Derivative for Appetite Reduction

The European Patent Office published application EP3474833A1 for Symrise AG covering a cinnamyl alcohol derivative for reducing appetite and generating satiety. The invention lists Veronika Somoza, Barbara Lieder, Katrin Geissler, Joachim Hans, Kathrin Langer, Jakob Peter Ley, and Sabine Widder as inventors. The application classifies under A61K 31/015, A61K 31/185, and A61K 31/215. Validated designated states include DE, FR, GB, IT, ES, NL, and other EPC contracting states.

Routine Notice Intellectual Property

Pharmaceutical Composition Comprising Lipoic Acid and Taurine as Osmoprotective Agent

The EPO granted Patent EP3297733A1 to Dulcis Health Science for a pharmaceutical composition combining lipoic acid and taurine as an osmoprotective agent. The patent, published April 8, 2026, lists inventors Claret, Martine, Claret, Claude, and Chatard-Baptist, Caroline, with designations covering all 31 European Patent Convention member states.

Routine Rule Intellectual Property

Long-Acting Injectable Formulations Comprising an Isoxazoline Active Agent (EP3261617A1)

The European Patent Office published European patent application EP3261617A1 for Boehringer Ingelheim Vetmedica GmbH covering long-acting injectable formulations comprising isoxazoline active agents. The application classifies under IPC codes A61K 31/422, A61K 31/42, A61K 9/00, and A01N 43/80. The application designates 36 European contracting states including Germany, France, United Kingdom, Italy, Spain, and other EU member states.

Routine Rule Intellectual Property

Shiseido Skin Glow Evaluation Method Patent EP3219302A1

The European Patent Office published Shiseido Company Ltd.'s patent application EP3219302A1 covering methods for evaluating skin glow, methods for examining skin glow improving agents, and skin glow improving compositions. The patent application was published on April 8, 2026, designating 37 European states including DE, FR, GB, IT, ES, and others. The application includes inventors Masuda Yuji, Yagi Eiichiro, and Kuwahara Tomohiro.

Routine Notice Intellectual Property

2d ago • PMPRB

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.

Routine Notice Pharmaceuticals

2d ago • PMPRB

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.

Routine Notice Pharmaceuticals

2d ago • PMPRB

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.

Priority review Notice Pharmaceuticals

2d ago • PMPRB

PMPRB News Archive Results Page

The Patented Medicine Prices Review Board (PMPRB) published a news archive search results page displaying 79 results. The page serves as a navigational interface to the PMPRB's published news content on Canada.ca.

Routine Notice Pharmaceuticals

2d ago • PMPRB

Proposed Practice Directions on Mode of Hearings, Document Exchange, Motions, Filing, AI Use, Virtual Proceedings

The Patented Medicine Prices Review Board (PMPRB) is consulting on seven proposed practice directions to modernize its hearing procedures. The directions address mode of hearings (defaulting to paper hearings for evidentiary portions), document exchange facilitation, motion standardization, electronic filing and page limits, expedited failure-to-file proceedings, use of artificial intelligence in proceedings, and virtual proceedings. Stakeholders may submit comments on these proposed directions.

Routine Consultation Healthcare

1d ago • Regs.gov: Food and Drug Administration

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.

Routine Notice Pharmaceuticals

1d ago • Regs.gov: Food and Drug Administration

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.

Routine Notice Pharmaceuticals

1d ago • Regs.gov: Food and Drug Administration

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.

Routine Notice Food Safety

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.

Urgent Enforcement Pharmaceuticals

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.

Urgent Enforcement Medical Devices

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.

Priority review Enforcement Medical Devices