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Cuban Drug Jusvinza Advances Through Phase III Trial for Rheumatoid Arthritis Treatment

Drug Approval
  • Jusvinza, developed by Cuba's Center for Genetic Engineering and Biotechnology, is currently undergoing a Phase III clinical trial for rheumatoid arthritis treatment following conditional registration in September 2023.
  • The placebo-controlled, double-blind trial includes patients with moderate rheumatoid arthritis and aims to corroborate the drug's efficacy, with initial results showing good safety profile and only mild, reversible adverse events.
  • Clinical studies are expanding to investigate Jusvinza's potential in other autoimmune diseases including ankylosing spondylitis, systemic lupus erythematosus, and inflammatory bowel diseases.
  • The drug has demonstrated effectiveness in controlling hyperinflammation and has shown benefits in real-world studies of severe rheumatoid arthritis patients, with definitive registration expected next year.

ToolGen Files Patent Infringement Lawsuit Against Vertex Over CRISPR Gene Therapy Casgevy

Drug Approval
  • Korean biotech company ToolGen has filed patent infringement lawsuits against Vertex Pharmaceuticals in the UK and Netherlands over the world's first approved CRISPR gene therapy, Casgevy.
  • ToolGen claims Vertex's $2.2 million therapy was developed using its proprietary CRISPR RNP technology without proper licensing recognition.
  • The lawsuit targets Casgevy, which treats sickle cell disease and beta-thalassemia and has received marketing authorization in the UK, EU, and US.
  • ToolGen seeks a global licensing agreement rather than restricting patient access to the breakthrough therapy.

Cemiplimab Shows Significant Survival Benefit in NSCLC Patients with Brain Metastases and High PD-L1 Expression

Monoclonal AntibodyDrug ApprovalOncology
  • First-line cemiplimab (Libtayo) monotherapy demonstrated a remarkable survival advantage over chemotherapy in advanced NSCLC patients with PD-L1 ≥50% and brain metastases, with median OS of 52.4 vs 20.7 months.
  • The EMPOWER-Lung 1 trial's 5-year follow-up data confirms cemiplimab's long-term clinical benefits across all PD-L1 expression levels, with the greatest benefit observed in patients with PD-L1 ≥90%.
  • Patients receiving cemiplimab experienced fewer grade ≥3 adverse events compared to chemotherapy (18.3% vs 39.9%), while also reporting improved quality of life measures including better emotional functioning and reduced fatigue.

A Study to Investigate the Efficacy of Durvalumab Plus Tremelimumab in Combination With Chemotherapy Compared With Pembrolizumab in Combination With Chemotherapy in Metastatic NSCLC Patients With Non-squamous Histology Who Have Mutations and/or Co-mutations in STK11, KEAP1, or KRAS

NCT06008093RecruitingPhase 3
AstraZeneca
Posted 4/4/2024

Study of REGN 2810 Compared to Platinum-Based Chemotherapies in Participants With Metastatic Non-Small Cell Lung Cancer (NSCLC)

NCT03088540CompletedPhase 3
Regeneron Pharmaceuticals
Posted 5/29/2017

A Study of CS1001 in Subjects With Stage IV Non-Small Cell Lung Cancer

NCT03789604Active, Not RecruitingPhase 3
CStone Pharmaceuticals
Posted 12/13/2018

Combinations of Cemiplimab (Anti-PD-1 Antibody) and Platinum-based Doublet Chemotherapy in Patients With Lung Cancer

NCT03409614CompletedPhase 3
Regeneron Pharmaceuticals
Posted 3/6/2018

Ipsen Secures Dual CHMP Approvals for Rare Liver Disease Treatments Following Regulatory Strategy Shift

Drug ApprovalRare DiseaseOrphan Drug
  • Ipsen received CHMP approval for odevixibat under the new brand name Kayfanda for Alagille syndrome, marking the second approval for the same drug after rebranding due to orphan status complications.
  • The company simultaneously secured CHMP recommendation for Iqirvo (elafibranor) as a treatment for primary biliary cholangitis, representing a rare dual approval achievement.
  • Odevixibat demonstrated statistically significant improvements in scratching severity in the ASSERT trial, the world's first phase 3 study completed in Alagille syndrome patients.
  • Both approvals address significant unmet medical needs in rare cholestatic liver diseases, with analysts estimating the PBC market alone could exceed $1.5 billion annually.

Chugai's Vabysmo Becomes First Approved Treatment for Angioid Streaks in Japan

Drug ApprovalRare Disease
  • Chugai Pharmaceutical has received Japanese regulatory approval for Vabysmo as the first-ever treatment for choroidal neovascularization associated with angioid streaks, a rare eye disease that can lead to vision loss.
  • The approval follows positive Phase III NIHONBASHI study results showing statistically significant visual acuity improvement of +5.8 letters at week 12 and a reduction in central retinal thickness of -106.4 μm.
  • Vabysmo, a bispecific antibody targeting both VEGF-A and Ang-2 pathways, was generally well-tolerated with no new safety concerns identified during the clinical trial.

FDA Approves 25 First-Time Generic Drugs in First Half of 2025, Expanding Access to Critical Therapies

FDA ApprovalDrug ApprovalOncology
  • The FDA approved 25 first-time generic drugs in the first six months of 2025, including generics for critical medications treating HIV, cancer, and neurological conditions.
  • Notable approvals include generic versions of Xarelto (rivaroxaban) for blood clot prevention, Complera for HIV treatment, and Fycompa (perampanel) for seizure management.
  • These generic approvals span diverse therapeutic areas from oncology to ophthalmology, potentially reducing healthcare costs while maintaining equivalent clinical benefits to brand-name products.

Alembic Pharmaceuticals Secures USFDA Approvals for Carbamazepine and Amlodipine-Atorvastatin Generics

Drug Approval
  • Alembic Pharmaceuticals has received final USFDA approval for generic Carbamazepine 200 mg tablets, an anticonvulsant used for seizure disorders and neuropathic pain with a US market size of approximately $32 million.
  • The company also secured approval for Amlodipine-Atorvastatin combination tablets in multiple strengths, expanding its portfolio in the cardiovascular therapeutic area.
  • With these recent approvals, Alembic now holds a total of 223 ANDA approvals from the USFDA, strengthening its position in the US generics market across CNS and cardiovascular segments.

Bayer Secures FDA Approval for Nubeqa in Metastatic Prostate Cancer, Targeting €3 Billion Peak Sales

OncologyDrug Approval
  • Bayer received FDA approval for Nubeqa (darolutamide) in combination with docetaxel chemotherapy for metastatic hormone-sensitive prostate cancer, expanding beyond its initial non-metastatic indication.
  • The ARASENS trial demonstrated a 33% reduction in death risk when Nubeqa was added to standard androgen deprivation therapy plus docetaxel compared to placebo.
  • Bayer has tripled its peak sales forecast for Nubeqa from €1 billion to €3 billion following positive clinical data in the metastatic setting.
  • The approval positions Nubeqa to compete directly with established androgen receptor inhibitors Xtandi and Erleada in the advanced prostate cancer market.

Eli Lilly CEO David Ricks Tops Pharma Executive Compensation at $29.2 Million in 2024

Drug Approval
  • Eli Lilly CEO David Ricks earned $29.2 million in 2024, surpassing Johnson & Johnson's Joaquin Duato to become the highest-paid pharmaceutical executive with a 10% increase from 2023.
  • Ricks' compensation reflects Lilly's exceptional performance, including 32% revenue growth to $45 billion and successful launches of weight loss drug Zepbound and Alzheimer's treatment Kisunla.
  • The top six highest-paid pharma CEOs all earned over $23 million, with Pfizer's Albert Bourla receiving a 14% pay increase to $24.6 million following the company's cost realignment program.
  • Executive compensation packages are primarily driven by stock options, with Ricks receiving $19.7 million in stock awards as part of his total compensation package.

FDA Approves First Lupus Nephritis Treatment: GSK's Benlysta Autoinjector for Pediatric Patients

Drug ApprovalMonoclonal Antibody
  • GSK received FDA approval for Benlysta's 200 mg/mL autoinjector for subcutaneous injection in patients five years and older with active lupus nephritis, marking the first FDA-approved treatment specifically for this severe kidney complication.
  • The approval provides pediatric lupus nephritis patients with a first-of-its-kind at-home subcutaneous treatment option, expanding beyond the previously available intravenous formulation.
  • Benlysta demonstrated clinical efficacy in the BLISS-LN trial, with 43% of patients achieving significant kidney function improvement compared to 32% in the control group.
  • The lupus nephritis indication is expected to drive Benlysta sales above the $1 billion blockbuster threshold, with GSK estimating around 60% of severe SLE patients in the US suffer from lupus nephritis annually.

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