MedPath

Tagged News

Aquestive Therapeutics Receives FDA Approval for Anaphylm New Drug Application, Targeting $2 Billion Severe Allergic Reaction Market

Drug Approval
  • The U.S. Food and Drug Administration has approved Aquestive Therapeutics' New Drug Application for Anaphylm, a sublingual epinephrine product for treating severe allergic reactions.
  • Anaphylm represents a non-device-based alternative to traditional autoinjectors like EpiPen and Auvi-Q, offering wallet portability and rapid onset for emergency anaphylaxis treatment.
  • The FDA has set a Prescription Drug User Fee Act date of January 31, 2026, with the product positioned to capture market share in a $2 billion addressable market.
  • Clinical data demonstrates that Anaphylm achieves outcomes comparable to existing autoinjector products while providing unique sublingual administration advantages over nasal spray formulations.

Federal Judge Blocks Mass Layoffs at HHS, Citing Likely Unlawful Staff Cuts

Drug Approval
  • A federal judge has halted the Trump administration's mass layoffs at the Department of Health and Human Services, ruling the cuts likely violated federal law and caused irreparable harm.
  • The decision affects over 20,000 eliminated positions across key agencies including the CDC, FDA, and NIH, with the FDA losing approximately 3,500 workers.
  • Health Secretary Robert F. Kennedy Jr. had cut more than 10,000 workers and merged 28 agencies into 15 as part of the administration's restructuring plan.
  • The court ruling blocks further layoffs while litigation continues, with HHS required to report back by July 11.

FDA Approves First Triple Combination Hypertension Pill as June 2025 Delivers Major Cardiovascular Advances

Drug Approval
  • The FDA approved GMRx2 (Widaplik), the first single-pill triple combination therapy containing telmisartan, amlodipine, and indapamide for initial hypertension treatment in adults likely needing multiple drugs.
  • Merck's Phase 3 HYPERION trial showed sotatercept-csrk significantly reduced time to clinical worsening in newly diagnosed pulmonary arterial hypertension patients at intermediate or high risk.
  • New STRIDE trial subanalysis data demonstrated semaglutide 1.0 mg reduced peripheral artery disease progression by 54% in patients with type 2 diabetes.
  • The CONFIDENCE trial revealed that simultaneous initiation of finerenone and empagliflozin led to a 52% reduction in urinary albumin-to-creatinine ratio in patients with chronic kidney disease and type 2 diabetes.

Delhi High Court Orders CDSCO to Review Safety of GLP-1 Diabetes Drugs Used for Weight Loss

Drug Approval
  • The Delhi High Court has directed India's Central Drugs Standard Control Organisation (CDSCO) to decide within three months on a petition challenging the licensing of GLP-1 receptor agonist drugs for weight loss treatment.
  • The petition raises safety concerns about semaglutide, tirzepatide, and liraglutide being approved for weight management despite limited India-specific clinical trial data and inadequate safety evaluation.
  • These drugs were originally developed for Type 2 diabetes treatment but have been repurposed for obesity management, with the petitioner citing risks including pancreatitis, gastrointestinal damage, and potential cancers.
  • The court emphasized that CDSCO must consult experts and relevant stakeholders before making its decision on the regulatory concerns raised in the petition.

Hikma Receives FDA Approval for TYZAVAN™, First Ready-to-Infuse Vancomycin Formulation for Sepsis Treatment

Drug Approval
  • Hikma Pharmaceuticals received FDA approval for TYZAVAN™, the first ready-to-infuse vancomycin formulation that requires no preparation, targeting critical sepsis treatment where survival rates decrease by 15% after 87-113 minutes.
  • The glycopeptide antibiotic is indicated for septicemia, infective endocarditis, skin infections, bone infections, and lower respiratory tract infections in adults and pediatric patients over one month old.
  • TYZAVAN™ offers room-temperature stability with 16-month shelf life, seven dosing presentations (0.5g-2g), and compatibility with automated dispensing cabinets to streamline hospital workflows.
  • The US vancomycin injection market was valued at approximately $200 million in 2024, with sepsis affecting one person every 20 seconds and causing death every two minutes in the United States.

Celltrion Advances Pembrolizumab Biosimilar Development as Herceptin Copy Nears European Launch

Monoclonal AntibodyDrug ApprovalOncology
  • Celltrion has initiated development of a biosimilar version of Merck's pembrolizumab (Keytruda), starting work 10 years ahead of the drug's patent expiration in June 2028.
  • The company's trastuzumab biosimilar Herzuma has gained EU approval and is expected to be priced up to 50% cheaper than Roche's subcutaneous Herceptin.
  • Biosimilar competitors will primarily target the intravenous Herceptin market, representing less than $1 billion in total European sales as most patients have switched to the more convenient subcutaneous formulation.

Hengrui Pharmaceutical Secures NMPA Approval for JAK1 Inhibitor Ivarmacitinib in Severe Alopecia Areata

Drug Approval
  • Hengrui Pharmaceutical received NMPA approval for Ivarmacitinib Sulfate Tablets, a second-generation JAK1 inhibitor, for treating severe alopecia areata in China.
  • Phase III clinical trials demonstrated a 40% response rate at 24 weeks compared to 9% for placebo, representing a significant therapeutic advancement for patients with this autoimmune condition.
  • The drug is already approved in China for multiple autoimmune conditions and has secured a $223 million licensing deal with Arcutis for North American and European markets.
  • Hengrui reported 21.78% year-over-year revenue growth to ¥13.6 billion in 2024, with innovative drug sales surging 33.25%.

Phase I Study on the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Subcutaneous Injection of SHR-2173 in Healthy Subjects

NCT06995001CompletedPhase 1
Guangdong Hengrui Pharmaceutical Co., Ltd
Posted 4/28/2024

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Subcutaneous Injections of SHR-2173 in Patients With Systemic Lupus Erythematosus

NCT06955598Active, Not RecruitingPhase 1
Guangdong Hengrui Pharmaceutical Co., Ltd
Posted 11/24/2024

FDA Approves Takeda's GAMMAGARD LIQUID ERC, First Ready-to-Use Low IgA Immunoglobulin Therapy for Primary Immunodeficiency

Drug Approval
  • The U.S. FDA has approved GAMMAGARD LIQUID ERC as the only ready-to-use liquid immunoglobulin therapy with low IgA content for primary immunodeficiency treatment in patients aged two and older.
  • The therapy contains less than or equal to 2 µg/mL IgA in a 10% solution and can be administered both intravenously and subcutaneously without reconstitution.
  • Takeda plans to discontinue its first-generation GAMMAGARD S/D product by December 2027, with commercialization of the new therapy beginning in the U.S. in 2026.
  • Primary immunodeficiency affects approximately 1 in 1,200 people in the United States and comprises more than 550 rare chronic disorders affecting immune system function.

China Approves ORPATHYS-TAGRISSO Combination for EGFR-Mutated Lung Cancer with MET Amplification

Drug ApprovalTargeted Therapy
  • China's National Medical Products Administration approved the ORPATHYS-TAGRISSO combination for treating EGFR-mutated non-small cell lung cancer patients with MET amplification after disease progression on EGFR inhibitor therapy.
  • The Phase III SACHI trial demonstrated a 66% reduction in disease progression risk compared to chemotherapy, with median progression-free survival of 8.2 months versus 4.5 months.
  • This represents the first all-oral, chemotherapy-free treatment option for this patient population, addressing a critical resistance mechanism in lung cancer therapy.
  • The approval triggers an $11 million milestone payment from AstraZeneca to HUTCHMED and marks the third indication for ORPATHYS in China.

Clinical Study on Savolitinib + Osimertinib in Treatment of EGFRm+/MET+ Locally Advanced or Metastatic NSCLC

NCT05009836RecruitingPhase 3
Hutchison Medipharma Limited
Posted 9/6/2021

A Phase II Study of HMPL-504 in Lung Sarcomatoid Carcinoma and Other Non-small Cell Lung Cancer

NCT02897479Unknown StatusPhase 2
Hutchison Medipharma Limited
Posted 12/1/2016

Savolitinib Plus Osimertinib Versus Platinum-based Doublet Chemotherapy in Participants With Non-Small Cell Lung Cancer Who Have Progressed on Osimertinib Treatment

NCT05261399RecruitingPhase 3
AstraZeneca
Posted 8/3/2022

Savolitinib vs. Sunitinib in MET-driven PRCC.

NCT03091192Active, Not RecruitingPhase 3
AstraZeneca
Posted 7/25/2017

Study on Savolitinib Combined With Osimertinib in Treatment of Advanced NSCLC With MET Amplification

NCT05015608Active, Not RecruitingPhase 3
Hutchison Medipharma Limited
Posted 11/22/2021

MEDI4736 Combinations in Metastatic Renal Cell Carcinoma

NCT02819596CompletedPhase 2
Queen Mary University of London
Posted 5/3/2016

Savolitinib for Treating Gastric Cancer and Esophagogastric Junction Adenocarcinoma Patients

NCT04923932Active, Not RecruitingPhase 2
Hutchison Medipharma Limited
Posted 7/27/2021

AZD9291 in Combination With Ascending Doses of Novel Therapeutics

NCT02143466Active, Not RecruitingPhase 1
AstraZeneca
Posted 8/5/2014

Savolitinib for Treating Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Patients

NCT04923945CompletedPhase 3
Hutchison Medipharma Limited
Posted 8/19/2021

A trial to learn how well osimertinib with savolitinib works in people with non-small cell lung cancer (NSCLC) that has gotten worse after initial treatment with osimertinib.

2024-512581-34-00Active, Not RecruitingPhase 2
AstraZeneca AB

Iterum Therapeutics Appoints Christine Coyne as Chief Commercial Officer to Lead ORLYNVAH Launch

Drug Approval
  • Iterum Therapeutics has appointed Christine Coyne as Chief Commercial Officer to lead the upcoming U.S. launch of ORLYNVAH, an FDA-approved oral antibiotic for uncomplicated urinary tract infections.
  • Coyne brings over 30 years of pharmaceutical commercial experience, including previous roles as Chief Commercial Officer at Innoviva and SCYNEXIS, with specific expertise in anti-infective portfolios.
  • ORLYNVAH represents a novel oral penem antibiotic targeting multi-drug resistant pathogens, including those with extended spectrum beta-lactamase resistance, addressing significant unmet medical needs.
  • The appointment comes at a pivotal time as Iterum prepares for commercial launch with partner EVERSANA, positioning the company for sustained growth in the anti-infective market.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.