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China Approves First Once-Daily Nebulized LAMA for COPD, Triggering $7.5M Milestone for Theravance

Drug Approval
  • China's NMPA has approved YUPELRI (revefenacin) as the first once-daily nebulized long-acting muscarinic antagonist for maintenance treatment of chronic obstructive pulmonary disease.
  • The regulatory approval triggers a $7.5 million milestone payment from Viatris to Theravance Biopharma, with additional sales milestones up to $37.5 million and tiered royalties of 14-20% on net sales.
  • Viatris assumes full responsibility for YUPELRI's launch and commercialization in China, while Theravance incurs no commercial costs in the region.
  • The approval strengthens Theravance's financial position, which includes $131 million in cash and potential near-term milestone payments from multiple revenue streams.

Phase 3 Efficacy and Durability of Ampreloxetine for the Treatment of Symptomatic NOH in Participants with Multiple System Atrophy

NCT05696717RecruitingPhase 3
Theravance Biopharma
Posted 6/27/2023

FDA Approves Enhanced Labeling for Endari Based on Post-Marketing Pharmacokinetic Data

Drug ApprovalRare Disease
  • Emmaus Life Sciences received FDA approval for enhanced labeling of Endari (L-glutamine oral powder) based on additional post-marketing pharmacokinetic study data.
  • The updated label provides more comprehensive prescribing information, including confirmation of body weight-based dosing, no unwanted accumulation with twice-daily dosing, and flexible administration with or without food.
  • Endari remains approved to reduce acute complications of sickle cell disease in adult and pediatric patients five years and older, addressing a condition affecting approximately 100,000 people in the United States.
  • The label enhancement represents a significant improvement in clinical guidance for healthcare providers treating sickle cell disease patients with this prescription-grade L-glutamine therapy.

Hong Kong Establishes Independent Drug Regulatory Authority by End 2026, Ending Reliance on Foreign Approvals

Drug Approval
  • Hong Kong will launch its own drug and medical device regulator by late 2026, marking a significant shift from the current secondary evaluation system that requires approval from at least two overseas regulators.
  • The Hong Kong Centre for Medical Products Regulation will implement primary evaluation in phases starting 2026, enabling fast-track approval of homegrown drugs and medical devices based on clinical trial data without foreign regulatory dependence.
  • Since 2023, 11 life-saving drugs including cancer treatments have been approved under the interim "1+" mechanism requiring only one overseas regulator's approval, demonstrating progress toward regulatory independence.
  • The city plans to apply for membership in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use in 2027 to achieve international recognition of its regulatory framework.

Teva Partners with Formycon to Commercialize Stelara Biosimilar Fymskina in Germany

Monoclonal AntibodyDrug Approval
  • Formycon AG has entered into a distribution agreement with Teva's subsidiary Ratiopharm for the semi-exclusive commercialization of its Stelara biosimilar FYB202, branded as Fymskina, in Germany.
  • The market launch for Fymskina is scheduled for the third quarter of 2025, with Formycon handling manufacturing and supply while Ratiopharm manages commercialization.
  • Fymskina has already received European Commission approval for treating moderate to severely active Crohn's disease, moderate to severe plaque psoriasis, and active psoriatic arthritis.
  • This partnership represents Formycon's strategic approach to expand market coverage through semi-exclusive partnerships, building on its existing global commercialization agreement with Fresenius Kabi.

Oral Sulopenem Shows Non-Inferiority to Standard Care in Phase 3 Trial for Uncomplicated UTIs

Drug Approval
  • Oral sulopenem (ORLYNVAH) demonstrated non-inferiority to amoxicillin/clavulanate in treating uncomplicated urinary tract infections in adult women, with overall success rates of 60.9% versus 55.6% respectively in the phase 3 REASSURE trial.
  • The study enrolled 2,222 adult women and showed sulopenem's statistical superiority in patients with baseline uropathogens susceptible to amoxicillin/clavulanate, achieving 61.7% success compared to 55.0%.
  • Adverse events were more frequent with sulopenem, particularly diarrhea (8.1% vs 4.1%), nausea (4.3% vs 2.9%), and headache (2.2% vs 1.5%), though these were predominantly mild in severity.
  • The FDA approved oral sulopenem in October 2024 as the first oral penem antibiotic in the US, specifically for patients with limited or no alternative oral antibacterial options.

Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women

NCT05584657CompletedPhase 3
Iterum Therapeutics, International Limited
Posted 10/18/2022

Valorum Biologics Secures Exclusive Rights to Commercialize Formycon's Eylea Biosimilar in North America

Drug Approval
  • Valorum Biologics LLC has secured exclusive commercialization rights for FYB203/AHZANTIVE®, Formycon's biosimilar to Eylea®, in the United States and Canada through a licensing agreement with Klinge Biopharma GmbH.
  • The FDA-approved biosimilar treats serious retinal diseases including wet age-related macular degeneration, diabetic macular edema, diabetic retinopathy, and macular edema following retinal vein occlusion by inhibiting VEGF.
  • Formycon will participate in mid-single-digit to low-double-digit percentage range of all payment streams and manage the supply chain, while Canadian regulatory approval is expected by the end of 2024.
  • The partnership leverages Valorum's experienced management team with proven track records at major pharmaceutical companies including Johnson & Johnson, Merck, and Roche to maximize market penetration.

Breckenridge Pharmaceutical Receives FDA Approval for Generic Dehydrated Alcohol Injection for Hypertrophic Obstructive Cardiomyopathy

Drug ApprovalRare Disease
  • Breckenridge Pharmaceutical received FDA approval for its generic version of Ablysinol, a dehydrated alcohol injection used to treat symptomatic hypertrophic obstructive cardiomyopathy in patients unsuitable for surgical myectomy.
  • The sterile, preservative-free solution contains ≥99% ethyl alcohol and is indicated for inducing controlled cardiac septal infarction to improve exercise capacity in adult HOCM patients.
  • This approval positions Breckenridge as one of the first companies to offer a generic alternative to Ablysinol in the U.S. market, supporting the company's strategy to expand its institutional healthcare presence.
  • The product will be available primarily in hospitals, clinics, and home health care facilities, reflecting Breckenridge's commitment to providing affordable treatment options for rare disease patients.

JB Chemicals Secures FDA Approval for Generic Amitriptyline Depression Treatment

Drug ApprovalFDA Approval
  • JB Chemicals and Pharmaceuticals Ltd received final FDA approval for its generic Amitriptyline Hydrochloride tablets in six dosage strengths for treating depression symptoms.
  • The approval allows the Indian pharmaceutical company to market its generic version of the tricyclic antidepressant in the US market, strengthening its regulated market presence.
  • This development supports JB Chemicals' international expansion strategy, with the company reporting 15.5% year-on-year net profit growth to ₹145.7 crore in the March quarter.
  • Analyst sentiment remains positive with 14 out of 15 analysts maintaining 'buy' ratings and price targets suggesting 11.4% potential upside.

Glenmark Launches Tevimbra, First Immuno-Oncology Drug in India for Lung and Esophageal Cancer Treatment

Monoclonal AntibodyDrug ApprovalOncology
  • Glenmark Pharmaceuticals has launched Tevimbra (tislelizumab), marking the company's first entry into immuno-oncology in India following CDSCO approval.
  • The anti-PD-1 monoclonal antibody is indicated for first-line treatment of locally advanced or metastatic NSCLC in combination with chemotherapy and second-line treatment as monotherapy.
  • Tevimbra is already approved in 46 countries including the US and EU, with over 1.5 million patients treated globally and worldwide sales of $625 million in 2024.
  • The drug targets NSCLC, which represents over 80% of lung cancer cases, and ESCC, the most common esophageal cancer subtype in India.

Zambon Secures Chinese Approval for Intravenous Fluimucil Following Successful Phase 3 Trial

Drug Approval
  • Zambon has received Chinese regulatory approval and launched the intravenous formulation of Fluimucil (N-acetylcysteine) for treating respiratory diseases with excessive mucus secretion.
  • A pivotal Phase 3 trial involving 333 patients across 28 Chinese hospitals demonstrated that IV Fluimucil was significantly superior to placebo and non-inferior to ambroxol in reducing sputum viscosity.
  • The approval follows a robust local clinical development program including Phase 1 and Phase 3 studies that confirmed the drug's safety, tolerability, and efficacy profile.
  • The launch marks Zambon's expansion in the Chinese market and celebrates the 60th anniversary of the Fluimucil molecule.

A Clinical Trial to Compare the Efficacy and Safety of 1-week Treatment of Intravenous N-acetylcysteine (NAC) 600 mg Twice Daily, Ambroxol Hydrochloride 30 mg Twice Daily and Placebo as Expectorant Therapies in Adult Chinese Patients With Respiratory Tract Diseases and Abnormal Mucus Secretions

NCT03843541CompletedPhase 3
Zambon SpA
Posted 6/25/2019

A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Multiple Intravenous Doses of N-acetylcysteine (NAC) in Chinese Healthy Volunteers

NCT03881163CompletedPhase 1
Zambon SpA
Posted 11/11/2019
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