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Sino Biopharm Reports Strong H1 2025 Results with 27% Growth in Innovative Drug Sales and Strategic LaNova Acquisition

Drug ApprovalOncology
  • Sino Biopharm achieved RMB17.57 billion in revenue for H1 2025, representing a 10.7% year-on-year increase, with innovative product sales reaching RMB7.8 billion, up 27.2%.
  • The company secured NMPA approval for two innovative products, Putanning and Anqixin, while maintaining a robust pipeline of 63 innovative drug candidates across four therapeutic areas.
  • Sino Biopharm completed the acquisition of LaNova Medicines in July 2025, gaining access to world-leading antibody discovery and ADC technology platforms to enhance R&D capabilities.
  • The company invested RMB3.19 billion in R&D during the period, representing 18.1% of revenue, supporting advancement of multiple Phase III trials including Lanifibranor for MASH treatment.

Influenza Pipeline Surges with 120+ Therapies as Moderna, AstraZeneca Lead Innovation Wave

Monoclonal AntibodyDrug Approval
  • The global influenza pipeline has expanded to include 120+ companies developing 120+ treatment therapies, with breakthrough innovations spanning vaccines, antibodies, and combination therapies.
  • Moderna's mRNA-1083 combination vaccine achieved primary endpoints in Phase III trials, demonstrating stronger immune responses than licensed comparator vaccines for both influenza and COVID-19.
  • AstraZeneca launched FluMist Home in August 2025, marking the first FDA-approved influenza vaccine for self-administration or caregiver delivery at home.
  • Leading pipeline candidates include Moderna's mRNA-1010 seasonal vaccine, SAB Biotherapeutics' broadly neutralizing antibody SAB-176, and innovative intranasal therapies targeting multiple respiratory viruses.

RedHill Biopharma Receives $1.1 Million in Talicia Licensing Payments Following First International Launch

Drug Approval
  • RedHill Biopharma received $1.1 million in milestone payments and royalties following Talicia's first commercial launch outside the United States in 2024.
  • Talicia demonstrated superior efficacy with 84% H. pylori eradication rates compared to 58% for standard therapy in pivotal Phase 3 trials (p<0.0001).
  • The FDA-approved rifabutin-based therapy addresses growing antibiotic resistance, with clarithromycin-based treatments showing only 68.5% effectiveness in recent studies.
  • Talicia holds eight years of U.S. market exclusivity under QIDP designation and patent protection through 2042, positioning it as the leading branded first-line H. pylori therapy.

NewAmsterdam's Obicetrapib Receives EMA Validation for European Review Following Positive Phase 3 Results

Drug Approval
  • The European Medicines Agency has validated Marketing Authorization Applications for obicetrapib monotherapy and obicetrapib-ezetimibe combination therapy, marking a significant regulatory milestone for NewAmsterdam Pharma.
  • Phase 3 trials demonstrated clinically meaningful LDL-C reductions of 35-40% with obicetrapib monotherapy and approximately 50% with the combination therapy, both showing safety profiles comparable to placebo.
  • The partnership with Menarini Group provides NewAmsterdam with potential milestone payments up to €863 million and tiered double-digit royalties, while Menarini handles European commercialization responsibilities.
  • With cardiovascular disease causing 17.9 million deaths annually and many patients failing to reach LDL-C targets despite existing therapies, obicetrapib could address a significant unmet medical need.

Randomized Study to Evaluate the Effect of Obicetrapib on Top of Maximum Tolerated Lipid-Modifying Therapies

NCT05142722CompletedPhase 3
NewAmsterdam Pharma
Posted 12/15/2021

Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies

NCT06005597CompletedPhase 3
NewAmsterdam Pharma
Posted 3/1/2024

Evaluate the Effect of Obicetrapib in Patients With HeFH on Top of Maximum Tolerated Lipid-Modifying Therapies.

NCT05425745CompletedPhase 3
NewAmsterdam Pharma
Posted 7/25/2022

Outlook Therapeutics Awaits Critical FDA Decision for Wet AMD Treatment ONS-5010

Drug Approval
  • Outlook Therapeutics' stock surged 11.97% in pre-market trading on August 18, 2025, as investors anticipate the FDA's decision on ONS-5010 (LYTENAVA) scheduled for August 27, 2025.
  • The investigational ophthalmic formulation of bevacizumab represents the company's second attempt at FDA approval after initial rejection in August 2023 due to chemistry, manufacturing, and controls issues.
  • ONS-5010 has already received European approval in May 2024 for wet age-related macular degeneration treatment and would receive 12 years of regulatory exclusivity if approved in the United States.
  • The company resubmitted its Biologics License Application in February 2025, addressing FDA concerns from the Complete Response Letter issued after the initial rejection.

Alembic Pharmaceuticals Receives FDA Approval for Generic Tretinoin Cream to Treat Acne Vulgaris

Drug Approval
  • Alembic Pharmaceuticals has received final FDA approval for its generic Tretinoin Cream USP (0.025%) to treat acne vulgaris in the US market.
  • The approved generic is therapeutically equivalent to Bausch Health's reference drug Retin-A Cream, targeting a market estimated at $94 million annually.
  • This approval brings Alembic's total ANDA portfolio to 224 applications, with 202 final approvals and 22 tentative approvals from the FDA.

Novo Nordisk's Wegovy Becomes First GLP-1 Therapy Approved for Liver Disease MASH

Drug Approval
  • The FDA granted accelerated approval for Novo Nordisk's Wegovy to treat metabolic dysfunction-associated steatohepatitis (MASH), making it the first GLP-1 therapy cleared for this serious liver condition.
  • In a Phase 3 trial, 37% of patients on Wegovy showed improved liver fibrosis at 72 weeks compared to 22.4% on placebo, while 63% achieved liver inflammation resolution versus 34.3% for placebo.
  • MASH affects approximately 5% of U.S. adults and can progress to serious or fatal outcomes when untreated, representing a significant unmet medical need.
  • The accelerated approval allows faster market access for this life-threatening condition, though the company has filed for additional regulatory approvals in Europe and Japan.

FDA Approves Precigen's PAPZIMEOS as First Gene Therapy for Recurrent Respiratory Papillomatosis

Drug ApprovalRare Disease
  • The FDA granted full approval to Precigen's PAPZIMEOS (zopapogene imadenovec-drba), marking the first and only treatment approved for adults with recurrent respiratory papillomatosis (RRP).
  • In clinical trials, 51% of patients achieved complete response with no surgeries needed for at least one year after treatment, with most remaining surgery-free two years later.
  • The approval triggered a dramatic pre-market surge of over 50% in Precigen's stock price, reflecting investor confidence in the company's innovative gene therapy platform.
  • PAPZIMEOS represents a breakthrough for approximately 27,000 U.S. adults suffering from RRP, a condition caused by HPV that previously required repeated surgical interventions.

AstraZeneca's FluMist Home Becomes First Self-Administered Flu Vaccine Available for Home Delivery in US

Drug Approval
  • AstraZeneca's FluMist Home is now available for home delivery in 34 US states, marking the first time Americans can self-administer a flu vaccine at home.
  • The nasal spray vaccine can be used by adults under 50 and children as young as 2 with parental assistance, following FDA approval for self-administration in September 2024.
  • The home delivery option aims to address low vaccination rates, as less than half of Americans received flu vaccines during the severe 2024-2025 season that caused up to 82 million illnesses.
  • AstraZeneca's usability study demonstrated 100% of intended users successfully administered a full dose without healthcare provider supervision.

FDA Approves First Immunotherapy for Recurrent Respiratory Papillomatosis

Drug ApprovalRare Disease
  • The FDA has approved zopapogene imadenovec-drba (Papzimeos) as the first non-replicating adenoviral vector-based immunotherapy for treating adult patients with recurrent respiratory papillomatosis.
  • In a pivotal Phase 1/2 trial, 51% of patients achieved complete response and at least 85% experienced decreased surgical intervention one year after treatment completion.
  • The approval represents a potential transformation for RRP treatment, offering lasting relief for patients who previously required repeated surgeries throughout their lifetime.
  • The therapy demonstrated a well-tolerated safety profile with no dose-limiting toxicities and no treatment-related adverse events greater than Grade 2.

A Study to Evaluate the Efficacy and Safety of JCAR017 in Adult Subjects With Relapsed or Refractory Indolent B-cell Non-Hodgkin Lymphoma (NHL)

NCT04245839RecruitingPhase 2
Celgene
Posted 7/14/2020

Gene Therapy for Male Patients With Danon Disease (DD) Using RP-A501; AAV9.LAMP2B

NCT03882437Active, Not RecruitingPhase 1
Rocket Pharmaceuticals Inc.
Posted 4/17/2019

A Gene Therapy Study of RP-A501 in Male Patients With Danon Disease

NCT06092034RecruitingPhase 2
Rocket Pharmaceuticals Inc.
Posted 9/5/2023

CAMPSIITE™ RGX-121 Gene Therapy in Subjects With MPS II (Hunter Syndrome)

NCT03566043Active, Not RecruitingPhase 2
REGENXBIO Inc.
Posted 9/27/2018

Adjuvant PRGN-2012 in Adult Patients With Recurrent Respiratory Papillomatosis

NCT04724980Active, Not RecruitingPhase 1
Precigen, Inc
Posted 3/16/2021

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