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Natco Pharma Launches Generic Bosentan for Pediatric Pulmonary Arterial Hypertension with 180-Day US Market Exclusivity

Drug Approval
  • Natco Pharma has launched generic Bosentan tablets (32 mg) for oral suspension in the US, securing 180-day market exclusivity as the first-to-file generic manufacturer.
  • The drug treats pulmonary arterial hypertension in pediatric patients aged 3 years and older, serving as a generic equivalent to Actelion's Tracleer tablets.
  • Lupin Ltd serves as the marketing partner for this product, which had estimated annual sales of USD 10 million in the US market according to recent industry data.
  • The launch represents a significant opportunity in the specialized pediatric PAH treatment market, addressing an important unmet need for affordable therapy options.

FDA Approves First Continuous Glucose Monitor for Weight Management Beyond Diabetes

Drug Approval
  • The FDA has approved Signos's continuous glucose monitoring system as the first-ever CGM specifically designed for weight management, extending access beyond traditional diabetes care to any consumer seeking weight loss support.
  • The system combines an AI platform with Dexcom's off-the-shelf CGM technology to provide real-time glucose data and personalized lifestyle recommendations, costing $129-139 for multi-month plans compared to roughly $1,000 monthly for GLP-1 medications.
  • With nearly 74% of Americans classified as overweight or obese and obesity costing the U.S. healthcare system over $170 billion annually, this approval represents a significant shift toward accessible, personalized weight management technology.
  • The device can be used independently or in combination with existing treatments like GLP-1 drugs or bariatric surgery, offering support for individuals across the weight loss spectrum from five to 100 pounds.

Health Canada Approves Iovance's AMTAGVI as First T-Cell Therapy for Solid Tumors in Canada

Drug Approval
  • Health Canada granted conditional marketing authorization for AMTAGVI, marking the first T-cell therapy approved for solid tumors in Canada, specifically for advanced melanoma treatment.
  • The approval is based on safety and efficacy data from the mid-stage C-144-01 trial, with conditional status pending confirmatory trials to demonstrate clinical benefit.
  • AMTAGVI is indicated for adult patients with unresectable or metastatic melanoma who have progressed after at least one prior systemic therapy and lack satisfactory treatment alternatives.
  • Iovance plans to authorize its first Canadian treatment center within months and continues pursuing approvals in additional international markets including the U.K., Australia, and Switzerland.

FDA Approves Nipocalimab for Myasthenia Gravis as Pipeline Advances with 20+ Novel Therapies

Drug ApprovalMonoclonal Antibody
  • The FDA approved nipocalimab (Imaavy) in May 2025 as the first therapy targeting the underlying cause of generalized myasthenia gravis in patients aged 12 and older with specific antibodies.
  • Over 20 companies are developing 22+ novel myasthenia gravis therapies, including promising candidates like Descartes-08, Telitacicept, and batoclimab showing sustained efficacy in Phase 2b and Phase 3 trials.
  • Recent clinical developments include Cartesian Therapeutics reporting 12-month sustained improvement with Descartes-08 and RemeGen sharing positive Phase 3 results for Telitacicept at the 2025 AAN Annual Meeting.

Study of Telitacicept in Generalized Myasthenia Gravis

NCT05737160CompletedPhase 3
RemeGen Co., Ltd.
Posted 3/28/2023

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

NCT04951622Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 7/15/2021

Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

NCT05403541Active, Not RecruitingPhase 3
Immunovant Sciences GmbH
Posted 6/27/2022

Descartes-08 for Patients With Systemic Lupus Erythematosus

NCT06038474RecruitingPhase 2
Cartesian Therapeutics
Posted 2/12/2024

FDA Issues Complete Response Letter for Darzalex Faspro in Newly Diagnosed Multiple Myeloma

Monoclonal AntibodyDrug Approval
  • The FDA issued a complete response letter for Johnson & Johnson's supplemental biologics license application for Darzalex Faspro in combination with VRd for newly diagnosed, transplant-ineligible multiple myeloma patients.
  • The CRL cited observations from facility inspections and was not related to safety and efficacy data, with no additional clinical studies requested by the FDA.
  • The phase 3 CEPHEUS trial demonstrated that D-VRd achieved significantly higher minimal residual disease negativity rates (60.9% vs 39.4%) compared to standard VRd treatment.
  • Darzalex Faspro remains available for all nine currently approved multiple myeloma indications in the United States with no impact on supply or availability.

A Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Participants With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

NCT03652064Active, Not RecruitingPhase 3
Janssen Research & Development, LLC
Posted 11/6/2018

Health Canada Approves Ozempic for Kidney Protection in Type 2 Diabetes Patients

Drug Approval
  • Health Canada approved Ozempic on August 13 to reduce kidney deterioration risk in Type 2 diabetes patients with chronic kidney disease.
  • The international FLOW trial demonstrated a 24% reduction in kidney failure risk among 3,533 patients compared to placebo over 3.4 years.
  • Ozempic becomes the first GLP-1 drug approved in Canada to protect both kidneys and heart in diabetic patients.
  • Between 30-50% of Type 2 diabetes patients develop chronic kidney disease, making this approval clinically significant.

Xspray Pharma Submits Improved Nilotinib Formulation XS003 to FDA for Chronic Myeloid Leukemia Treatment

Drug Approval
  • Xspray Pharma has submitted a New Drug Application to the FDA for XS003, an improved nilotinib formulation for chronic myeloid leukemia treatment using proprietary HyNap technology.
  • XS003 demonstrates the lowest documented food interaction within the nilotinib class and improved dose linearity, potentially eliminating the three-hour fasting requirement of the reference product Tasigna.
  • Registration studies show bioequivalence with Tasigna despite XS003 being administered at less than half the dose, with only 28% food interaction compared to 82% for the reference product.
  • The FDA is expected to initiate review within 60 days, with a regulatory decision anticipated approximately eight months thereafter, targeting a U.S. nilotinib market worth $850 million.

Roche Canada Secures Public Funding for Vabysmo in Quebec for Retinal Vein Occlusion Treatment

Drug Approval
  • Hoffmann-La Roche Limited announced that Vabysmo (faricimab injection) is now publicly funded for macular edema secondary to retinal vein occlusion on Quebec's RAMQ medication list.
  • The funding includes coverage for Vabysmo in a 6.0 mg single-use pre-filled syringe format, expanding treatment options for Quebec patients.
  • Vabysmo is now covered in Quebec for all three of its approved indications including neovascular age-related macular degeneration, diabetic macular edema, and macular edema secondary to RVO.
  • The bispecific antibody works by inhibiting both Ang-2 and VEGF-A pathways and has received authorization in over 100 countries for various retinal conditions.

Over-the-Counter Birth Control Pill Dramatically Increases Contraceptive Access Among Underserved Populations

Drug Approval
  • A nationwide OHSU study of 986 people across 49 states found a 31.8 percentage point increase in contraceptive use among those who previously used no birth control method after accessing over-the-counter pills.
  • The over-the-counter birth control pill particularly benefited racial and ethnic minorities, adolescents, uninsured individuals, and Medicaid recipients who faced the greatest barriers to reproductive healthcare access.
  • Research published in JAMA Network Open demonstrates that removing prescription requirements for oral contraceptives effectively expands access for underserved populations, especially in rural areas where healthcare access is limited.
  • The study provides clear evidence that the FDA's 2023 approval of over-the-counter birth control pills is addressing critical gaps in contraceptive access during a time of increasing reproductive health restrictions.

FDA Issues Draft Guidance Prioritizing Overall Survival as Primary Endpoint for Cancer Drug Approvals

Drug ApprovalOncology
  • The FDA has published new draft guidance emphasizing overall survival as the preferred primary endpoint for cancer drug trials, marking a shift toward prioritizing long-term patient outcomes in the approval process.
  • The guidance comes less than two weeks after the return of CBER Head Vinay Prasad, who has previously advocated for prioritizing overall survival over surrogate endpoints in oncology drug evaluations.
  • While the new requirements may make accelerated approval more challenging, the FDA still permits this pathway for drugs with significant uncertainty in OS findings but sufficient evidence of efficacy via intermediate clinical endpoints.
  • The guidance recommends limiting crossover study designs to avoid confounding overall survival analysis, permitting them only in diseases with no or very limited therapeutic options.

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