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Searle Secures Pakistani Regulatory Approval for Denosumab Biosimilar Injections

Monoclonal AntibodyDrug ApprovalOncology
  • The Searle Company Limited has obtained registration from Pakistan's Drug Regulatory Authority for Denosumab biosimilar injections in 60mg and 120mg doses.
  • The company holds marketing and sales rights in Pakistan under a licensing agreement with Chinese manufacturer Mabwell Pharmaceuticals.
  • The 60mg formulation targets osteoporosis management while the 120mg dose is intended for oncology care applications.
  • Searle is preparing for commercial launch, marking a significant expansion of its product portfolio in Pakistan's pharmaceutical market.

FDA Approves Pfizer-BioNTech LP.8.1-Adapted COVID-19 Vaccine for High-Risk Populations

Drug Approval
  • The FDA approved Pfizer-BioNTech's LP.8.1-adapted monovalent COVID-19 vaccine on August 27 for adults 65 and older and individuals aged 5-64 with high-risk conditions.
  • The approval was based on cumulative safety and efficacy evidence, including clinical trial data supporting use in children aged 5-11 years.
  • Pre-clinical data demonstrated the LP.8.1-adapted vaccine generates improved immune responses against multiple circulating SARS-CoV-2 sublineages compared to previous JN.1 and KP.2-adapted vaccines.
  • The vaccine targets contemporary viral sublineages including XFG, NB.1.8.1, and other circulating variants to provide enhanced protection against severe COVID-19 outcomes.

Major Pharmacy Chains Limit COVID-19 Vaccine Access Following FDA Approval of 2025-2026 Formulation

Drug Approval
  • The FDA has approved updated COVID-19 vaccines for 2025-2026 but restricted their use to adults 65 and older and individuals with risk factors for severe COVID-19.
  • CVS Pharmacy cannot offer COVID-19 vaccines in 16 states including New York due to regulatory requirements and is awaiting CDC approval through ACIP recommendations.
  • Both CVS and Walgreens are limiting vaccine offerings to comply with state pharmacy laws and federal regulations, creating a patchwork of availability across the United States.
  • Access to the new vaccines depends on decisions by federal health advisers, health insurers, pharmacies, and state authorities, potentially delaying availability for weeks.

Olezarsen Achieves 60% Triglyceride Reduction in Phase 3 Trial for Cardiovascular Risk Patients

Drug Approval
  • Monthly olezarsen injections reduced triglyceride levels by approximately 60% at 6 months compared to placebo in patients with moderate hypertriglyceridemia and elevated cardiovascular risk.
  • More than 80% of patients treated with olezarsen achieved normal triglyceride levels (below 150 mg/dL) at both 6 and 12 months, compared to only 12.5% with placebo at 6 months.
  • The phase 3 ESSENCE-TIMI 73b trial demonstrated superior triglyceride lowering compared to current standard therapies, with no major safety concerns identified.
  • Olezarsen also significantly reduced remnant cholesterol, non-HDL cholesterol, and apolipoprotein B levels without affecting LDL cholesterol.

A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia

NCT05552326CompletedPhase 3
Ionis Pharmaceuticals, Inc.
Posted 8/31/2022

A Study of Olezarsen (ISIS 678354) Administered to Participants With Severe Hypertriglyceridemia

NCT05079919CompletedPhase 3
Ionis Pharmaceuticals, Inc.
Posted 10/25/2021

Teva Receives FDA Approval for Generic Saxenda, Targeting $165 Million Weight Management Market

Drug Approval
  • Teva Pharmaceutical Industries announced FDA approval and U.S. launch of its generic version of Saxenda (liraglutide injection) in late August 2025, targeting a branded product with annual sales of $165 million.
  • The generic launch represents a significant expansion of Teva's portfolio into the growing weight management segment, potentially capturing market share from the high-revenue branded medication.
  • Analysts view Teva as undervalued by over 20%, with projections for accelerated biosimilar launches through 2027 expected to drive higher-margin revenue streams and offset traditional generics headwinds.
  • Despite positive momentum from new product launches, Teva faces ongoing challenges from heavy debt burden and reliance on a limited number of branded drugs in its recovery strategy.

India Streamlines Drug Development Process with Digital Applications and Faster Approval Timelines

Drug Approval
  • India's health ministry proposes amendments to the New Drugs and Clinical Trials Rules (NDCTR) 2019, mandating online applications for new drug manufacturing approvals and bioequivalence studies.
  • The regulatory timeline for manufacturing approval decisions will be reduced from 90 working days to 45 working days, potentially accelerating drug development processes.
  • New notification-based system allows manufacturers to produce certain investigational drugs for analytical and preclinical testing without waiting for formal approval, excluding high-risk categories like cytotoxic and narcotic substances.
  • Bioavailability and bioequivalence studies for export-only oral dosage forms can now proceed with simplified notification procedures under specific conditions, including ethics committee approval and sample size limitations.

NICE Approves Guselkumab for Moderate to Severe Ulcerative Colitis and Crohn's Disease

Drug ApprovalMonoclonal Antibody
  • NICE has recommended guselkumab (Tremfya) as a treatment option for adults with moderately to severely active ulcerative colitis and Crohn's disease when conventional treatments and TNF-alpha inhibitors have failed.
  • The IL-23 inhibitor demonstrated effectiveness comparable to existing biologics mirikizumab and vedolizumab through indirect comparisons, with similar or lower costs.
  • Guselkumab will be available through the NHS in England within 30 days of final guidance publication, expanding treatment options for patients with refractory inflammatory bowel disease.

Sanofi's Wayrilz Becomes First BTK Inhibitor Approved for Immune Thrombocytopenia Treatment

Drug ApprovalOrphan DrugRare Disease
  • The FDA approved Wayrilz (rilzabrutinib) as the first BTK inhibitor for adults with persistent or chronic immune thrombocytopenia who have insufficient response to prior treatments.
  • The approval was based on the LUNA 3 phase 3 study showing 23% of Wayrilz patients achieved durable platelet response at week 25 compared to 0% in the placebo group.
  • Wayrilz targets the root causes of ITP through multi-immune modulation, offering a novel mechanism of action for the more than 25,000 US adults who could benefit from advanced treatment.
  • The drug demonstrated faster time to platelet response (36 days vs. not reached with placebo) and improved quality of life measures across nine health-related domains.

Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)

NCT04562766Active, Not RecruitingPhase 3
Principia Biopharma, a Sanofi Company
Posted 12/14/2020

FDA Approves Medtronic's Evolut TAVR Systems for Expanded Redo-TAVR Indication

Drug Approval
  • Medtronic received FDA approval for expanded Redo-TAVR indication of its Evolut transcatheter aortic valve replacement systems, allowing implantation inside any failed previously implanted TAV.
  • The approval covers Evolut PRO+, FX, and FX+ systems for high-risk surgical patients with failing transcatheter heart valves from any manufacturer.
  • Medtronic launched the RESTORE study to evaluate Redo-TAVR outcomes in 225 participants over five years, focusing on procedural success rates and long-term clinical outcomes.
  • The expanded indication provides physicians with more treatment options beyond existing valve-in-valve procedures and benefits future TAVR patients by offering intervention possibilities.

Johnson & Johnson Halts Rheumatoid Arthritis Trial for Nipocalimab, Refocuses on Rare Disease Markets

Rare DiseaseDrug Approval
  • Johnson & Johnson discontinued its Phase 2 DAISY trial of nipocalimab combined with anti-TNFα therapy for rheumatoid arthritis after failing to demonstrate sufficient added benefit over monotherapy at 12 weeks.
  • The company is strategically pivoting nipocalimab development toward rare diseases and maternal-fetal conditions where the drug has shown stronger clinical differentiation and faces less competition.
  • Nipocalimab has already secured FDA approval for generalized myasthenia gravis as IMAAVY and received Breakthrough Therapy designation for hemolytic disease of the fetus and newborn.
  • The strategic shift positions J&J to capitalize on high-value niche markets with premium pricing potential and regulatory incentives including Orphan Drug status.

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