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FDA Approves Tevimbra-Chemotherapy Combination for First-Line Treatment of Advanced Esophageal Squamous Cell Carcinoma

Monoclonal AntibodyOncologyFDA Approval
  • The FDA has approved BeiGene's Tevimbra (tislelizumab-jsgr) in combination with platinum-containing chemotherapy for first-line treatment of adults with unresectable or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1.
  • In the pivotal RATIONALE-306 trial, patients treated with Tevimbra plus chemotherapy demonstrated a median overall survival of 16.8 months compared to 9.6 months with chemotherapy alone, representing a 34% reduction in risk of death.
  • This marks BeiGene's third FDA approval in less than a year, following previous approvals for Tevimbra in second-line ESCC and first-line gastric/gastroesophageal junction cancers, highlighting the company's expanding oncology portfolio.

Study of Platinum Plus Etoposide With or Without Tislelizumab in Participants With Untreated Extensive-Stage Small Cell Lung Cancer

NCT04005716CompletedPhase 3
BeiGene
Posted 7/22/2019

Tislelizumab in Combination With Chemotherapy as First-Line Treatment in Adults With Inoperable, Locally Advanced or Metastatic Gastric, or Gastroesophageal Junction Carcinoma

NCT03777657CompletedPhase 3
BeiGene
Posted 12/13/2018

Comparing the Efficacy and Safety of a New Additional Treatment With Tislelizumab in Non-Small Cell Lung Cancer (NSCLC)

NCT04379635Active, Not RecruitingPhase 3
BeiGene
Posted 5/29/2020

A Study of Tislelizumab (BGB-A317) Versus Chemotherapy as Second Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03430843CompletedPhase 3
BeiGene
Posted 1/26/2018

A Study of Tislelizumab (BGB-A317) in Combination With Chemotherapy as First Line Treatment in Participants With Advanced Esophageal Squamous Cell Carcinoma

NCT03783442CompletedNot Applicable
BeiGene
Posted 12/11/2018

Tislelizumab Combined With Chemotherapy Versus Chemotherapy Alone in Recurrent or Metastatic Nasopharyngeal Cancer (NPC)

NCT03924986CompletedPhase 3
BeiGene
Posted 3/27/2019

Federal Court Denies Novartis Injunction Against Entresto Generic, Clearing Path for MSN Launch

FDA Approval
  • A Delaware federal judge denied Novartis' preliminary injunction request against MSN Pharmaceuticals, ruling the company failed to prove patent infringement for its blockbuster heart failure drug Entresto.
  • The court rejected Novartis' claims of irreparable harm, stating it was unreasonable to attribute potential market damage from other generic competitors to MSN's individual product launch.
  • MSN's generic version of Entresto, approved by the FDA in July 2024, represents the first U.S. generic competitor to Novartis' top-performing asset that generated over $6 billion in 2023 revenue.
  • The ruling follows the FDA's recent denial of Novartis' citizen petition seeking to block generic approvals, though Novartis has placed a temporary three-day hold while pursuing appeals.

FDA Approves Merck's CAPVAXIVE: First 21-Serotype Pneumococcal Vaccine Designed Specifically for Adults

FDA Approval
  • The FDA has approved Merck's CAPVAXIVE, a novel 21-valent pneumococcal conjugate vaccine specifically designed to protect adults against serotypes causing the majority of invasive pneumococcal disease.
  • CAPVAXIVE includes eight unique serotypes not covered by other approved pneumococcal vaccines, targeting approximately 84% of invasive pneumococcal disease cases in adults over 50, compared to 52% covered by PCV20.
  • The single-dose vaccine demonstrated robust immunogenicity across various adult populations, with the CDC's Advisory Committee on Immunization Practices expected to make recommendations for its use later this month.

Safety and Immunogenicity of V116 in Pneumococcal Vaccine-naïve Adults (V116-003, STRIDE-3)

NCT05425732CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 7/13/2022

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 in Pneumococcal Vaccine-experienced Adults (V116-006, STRIDE-6)

NCT05420961CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 7/12/2022

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of V116 When Administered Concomitantly With Influenza Vaccine in Adults 50 Years of Age or Older (V116-005, STRIDE-5)

NCT05526716CompletedPhase 3
Merck Sharp & Dohme LLC
Posted 9/23/2022

Bio-Thera's BAT8006 Shows Promising 37% Response Rate in Platinum-Resistant Ovarian Cancer Phase I Trial

FDA Approval
  • Bio-Thera Solutions reported that BAT8006, a folate receptor-α antibody drug conjugate, achieved a 37% overall response rate in 54 patients with platinum-resistant ovarian cancer regardless of FR-α expression levels.
  • The Phase I study demonstrated favorable safety with manageable toxicity, no interstitial lung disease or notable ocular toxicity, and median progression-free survival of 7.47 months.
  • BAT8006 utilizes a unique bystander effect mechanism that allows it to eliminate neighboring cancer cells, potentially addressing tumor heterogeneity challenges.
  • The FDA has approved Bio-Thera to proceed with a Phase II clinical trial for BAT8006, expanding development beyond the ongoing Chinese Phase I study.

Pharmaceutical Industry Leadership Shuffle: Major Executive Appointments Signal Strategic Shifts Across Biotech and Pharma

CAR-TOncologyFDA Approval
  • AbbVie promoted long-time COO Robert Michael to CEO, marking the end of an extensive leadership search with an internal succession plan.
  • Multiple European biotechs appointed new CEOs, including OneChain Immunotherapeutics, Maxion Therapeutics, and StromaCare, reflecting strategic pivots in cancer immunotherapy development.
  • Astellas created its first chief digital and transformation officer role, signaling the pharmaceutical industry's increasing focus on digital transformation initiatives.
  • Acumen Pharmaceuticals strengthened its Alzheimer's drug development capabilities by appointing James Doherty, a neuroscience veteran with two FDA approvals under his belt.

FDA Analysis Reveals Decade of Growth in Rare Pediatric Disease Drug Development Through Priority Review Voucher Program

Rare DiseaseFDA Approval
  • The FDA's Rare Pediatric Disease Priority Review Voucher program granted 569 designations between 2013-2022, targeting 245 unique rare pediatric diseases across neurology, metabolism, and oncology therapeutic areas.
  • Gene therapies comprised 28% of all designations, reflecting the genetic nature of most rare diseases, while 38% of designations were supported by clinical data indicating advanced development stages.
  • The program awarded 38 priority review vouchers worth approximately $100 million each, providing crucial non-dilutive funding to rare disease drug developers.
  • A five-fold surge in designations occurred in 2020 when the program was set to expire, highlighting the uncertainty created by periodic reauthorization requirements.

First Veteran Receives FDA-Approved Qalsody for SOD1-ALS at Houston VA Medical Center

NeurologyRare DiseaseDrug ApprovalFDA Approval
  • Roy Swearingen, a 65-year-old Marine Corps veteran from Texas, became the first veteran in the United States to receive Qalsody, an FDA-approved medication for SOD1-mutated ALS.
  • Qalsody represents the first approved treatment targeting a genetic cause of ALS, specifically for patients with mutations in the superoxide dismutase 1 (SOD1) gene, affecting 1-2% of ALS patients.
  • The Houston VA ALS Center's rapid implementation of this cutting-edge therapy demonstrates the VA's commitment to providing veterans with timely access to innovative treatments.
  • Veterans face higher ALS risk compared to the general population, making early detection and specialized care crucial for optimal quality of life management.

Eli Lilly's Tirzepatide Shows Superior Weight Loss Results in Diabetes Patients, FDA Approval Expected by Year-End

FDA Approval
  • Eli Lilly's tirzepatide (Mounjaro) demonstrated up to 16% weight loss in diabetes patients with obesity over 17 months, representing unprecedented results for this challenging population.
  • The dual-hormone drug targets both GLP-1 and GIP pathways, showing superior efficacy compared to semaglutide-based medications like Ozempic and Wegovy.
  • FDA approval for weight management could come by end of 2023, potentially creating a $50 billion market and improving insurance coverage for patients.

UCLA Gene Therapy Achieves 100% Cure Rate for Bubble Baby Disease in Clinical Trials

FDA Approval
  • UCLA researchers led by Dr. Donald Kohn have successfully cured all 18 children with ADA-deficient SCID using a novel stem cell gene therapy approach over two clinical trials since 2009.
  • The breakthrough treatment uses patients' own genetically modified blood stem cells to restore immune function, eliminating the need for lifelong enzyme injections or risky bone marrow transplants.
  • All treated patients, ranging from 3 months to 4 years old, developed fully functioning immune systems without side effects and can now live normal lives.
  • The team is seeking FDA approval for the therapy and plans to extend the approach to treat sickle cell disease in clinical trials beginning in 2015.

Cook Medical's Zilver PTX Becomes First FDA-Approved Drug-Eluting Peripheral Stent in U.S. Market

FDA Approval
  • Cook Medical's Zilver PTX drug-eluting peripheral stent achieved FDA approval as the first device of its kind approved for peripheral artery use in the United States.
  • The device combines mechanical stenting with paclitaxel drug coating to reduce follow-up procedures by more than 50 percent in femoropopliteal artery treatment.
  • OhioHealth Riverside Methodist Hospital became the first U.S. institution to commercially implant the Zilver PTX stent following FDA approval.
  • The stent maintains arterial blood flow in seven out of ten patients through 24 months after implantation in the superficial femoral artery.

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