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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

HER2-Positive Gastric Cancer Pipeline Shows Robust Activity with 20+ Companies Developing Novel Therapies

Monoclonal AntibodyDrug Approval
  • DelveInsight's 2025 pipeline report reveals over 20 companies actively developing more than 20 innovative therapies for HER2-positive gastric cancer treatment.
  • Merck's KEYNOTE-811 Phase III trial achieved its dual primary endpoint of overall survival in July 2024, evaluating Keytruda combination therapy for first-line treatment.
  • ENHERTU received US approval in April 2024 as the first tumor-agnostic HER2-targeted therapy for metastatic HER2-positive solid tumors.
  • Leading pipeline candidates include SHR-A1811 from Jiangsu HengRui Medicine, Cinrebafusp alfa from Pieris Pharmaceuticals, and BI-1607 from BioInvent International.

FDA's Acting Drug Chief Jacqueline Corrigan-Curay to Retire Amid Leadership Exodus

Drug Approval
  • Jacqueline Corrigan-Curay, the FDA's acting director of the Center for Drug Evaluation and Research, announced her retirement in July after more than eight years at the agency.
  • Her departure adds to a significant leadership exodus at the FDA, with the agency losing approximately 20% of its workforce through layoffs and departures since the Trump administration took office.
  • The turnover occurs as FDA Commissioner Martin Makary implements major regulatory changes, including stricter COVID-19 vaccine standards and new AI adoption initiatives.
  • Despite leadership assurances that drug review timelines remain unaffected, some companies have reported unexpected delays attributed to "resource constraints."

FDA Approves First Bone Growth Accelerator for Spinal Fusion Surgery

Drug Approval
  • Cerapedics received FDA premarket approval for PearlMatrix P-15 Peptide Enhanced Bone Graft, the first proven bone growth accelerator for lumbar fusion procedures.
  • The ASPIRE pivotal trial demonstrated statistically superior fusion speed with over twice as many patients achieving fusion at six months compared to local autograft.
  • The approval addresses a critical unmet need in spinal fusion surgery, where bone fusion can take up to 12 months to complete.
  • PearlMatrix received FDA Breakthrough Device designation and represents one of only three spinal bone grafts with PMA approval among over 350 available products.

P-15L Bone Graft in Transforaminal Lumbar Interbody Fusion With Instrumentation

NCT03438747Active, Not RecruitingNot Applicable
CeraPedics, Inc
Posted 4/24/2018

EMA Recommends Approval of Alvotech's Biosimilar to Eylea for Eye Disorders

Drug Approval
  • The European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval for AVT06, Alvotech's proposed biosimilar to Eylea (aflibercept 2 mg).
  • The biosimilar is intended for treating adults with neovascular age-related macular degeneration, visual impairment due to macular edema secondary to retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization.
  • Alvotech's confirmatory clinical study demonstrated therapeutic equivalence between AVT06 and Eylea in patients with neovascular AMD, meeting the primary endpoint.
  • Global sales of Eylea reached approximately $9 billion in 2024, with one-third of these sales occurring in Europe.

CLINUVEL CEO Returns to Drive US Expansion with Vitiligo Treatment Approval Strategy

Drug ApprovalRare DiseaseLeadership Change
  • CEO Dr. Philippe Wolgen has returned to lead CLINUVEL Pharmaceuticals following his full recovery, positioning the company for its next growth phase in North America.
  • The company is pursuing approval of SCENESSE® for vitiligo treatment in the United States and Canada, which could represent a significant shift in CLINUVEL's business model.
  • CLINUVEL is accelerating US market presence through targeted M&A activities, with 104 of 120 EPP treatment centers currently active and ready for potential vitiligo patient treatment.
  • Analysts maintain a Buy recommendation with AUD 22.00 target price, representing 126% upside potential from current share price levels.

Idorsia's QUVIVIQ Receives Approval in China for Insomnia Treatment Through Simcere Partnership

Drug Approval
  • Simcere Pharmaceuticals has received approval from China's National Medical Products Administration for QUVIVIQ (daridorexant) to treat adult insomnia patients with difficulty falling asleep and/or maintaining sleep.
  • The approval was achieved in just 2.5 years from the initial licensing agreement signing, with QUVIVIQ receiving no psychotropic drug control labeling in China.
  • Idorsia will receive a $50 million approval milestone payment and up to $93 million in commercial milestones under the updated licensing agreement.
  • QUVIVIQ is now available to patients across North America, Europe, Japan, and China, establishing it as a truly global insomnia treatment brand.

FDA Approves Lenacapavir for HIV Prevention with 99.9% Efficacy, but High Cost Raises Accessibility Concerns in India

Drug Approval
  • The US FDA has approved lenacapavir, a new injectable HIV prevention drug offering 99.9% protection against HIV infection.
  • The drug costs approximately ₹24 lakh ($28,218) for two doses administered six months apart, raising significant affordability concerns in India.
  • India's National AIDS Control Organisation has not included PrEP medications in public healthcare programs, limiting access to private sector treatment.
  • Health experts advocate for government action and tiered pricing structures to improve accessibility, while UNAIDS urges price reductions for global access.

Aurobindo Pharma Secures Multiple FDA Approvals for Generic Drug Portfolio Expansion

Drug Approval
  • Aurobindo Pharma Limited has received FDA approval for multiple generic drug formulations, including critical medications for cardiovascular, neurological, and gastrointestinal conditions.
  • The company's recent approvals include AB-rated generic equivalents to major brand-name drugs such as Eliquis, Pradaxa, Chantix, and Nexium, expanding access to affordable treatment options.
  • These FDA approvals represent significant additions to Aurobindo's generic drug portfolio, covering therapeutic areas from anticoagulation to smoking cessation and acid reflux management.

European Medicines Agency Recommends Approval of Partner Therapeutics' IMREPLYS for Acute Radiation Syndrome Treatment

Drug Approval
  • The European Medicines Agency's Committee for Medicinal Products for Human Use has recommended approval of Partner Therapeutics' IMREPLYS (sargramostim) for treating patients exposed to myelosuppressive radiation doses.
  • IMREPLYS represents the same formulation as LEUKINE, which received FDA approval in 2018 for Hematopoietic Syndrome of Acute Radiation Syndrome in the United States.
  • European Commission approval is expected within 67 days, enabling sales and government stockpiling across all EU member states plus Norway, Iceland, and Liechtenstein.
  • The approval addresses critical preparedness needs amid current geopolitical threats involving tactical nuclear weapons and radiation exposure risks.

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