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FDA Approves Roche-AbbVie's Venclexta Plus Gazyva as First-Line Chemotherapy-Free Treatment for CLL

Drug Approval
  • The FDA has approved Venclexta (venetoclax) in combination with Gazyva (obinutuzumab) for previously untreated chronic lymphocytic leukemia and small lymphocytic lymphoma patients.
  • The approval is based on phase 3 CLL14 trial results showing significant reduction in disease progression risk compared to standard Gazyva plus chemotherapy treatment.
  • This represents the first chemotherapy-free, fixed-duration treatment option for first-line CLL therapy, potentially expanding the patient population by approximately 20,000 in the US.
  • Venclexta generated $344 million in worldwide sales last year, with AbbVie projecting sales to reach $725 million this year following the expanded indication.

Study of Acalabrutinib (ACP-196) in Combination With Venetoclax (ABT-199), With and Without Obinutuzumab (GA101) Versus Chemoimmunotherapy for Previously Untreated CLL

NCT03836261Active, Not RecruitingPhase 3
Acerta Pharma BV
Posted 2/25/2019

FDA Approves First Non-Surgical Treatment for Non-Muscle Invasive Bladder Cancer

Drug ApprovalOncology
  • The FDA approved UroGen Pharma's Zusduri as the first drug to treat non-muscle invasive bladder cancer that hasn't spread beyond the inner layers of the organ.
  • In a late-stage trial with 223 patients, 78% showed complete response with all signs of cancer disappearing after treatment.
  • The gel-based formulation offers a non-surgical alternative to traditional procedures, administered as a simple drug instillation in a doctor's office.
  • The approval addresses a significant unmet need for approximately 82,000 Americans affected by this type of bladder cancer annually, with 59,000 experiencing recurrence.

Amneal Secures FDA Approval for Generic Prednisolone Acetate Eye Drops, Targeting $201 Million Market

Drug Approval
  • Amneal Pharmaceuticals received FDA approval for prednisolone acetate ophthalmic suspension 1%, a generic version of Allergan's Pred Forte for treating steroid-responsive ocular inflammation.
  • The complex generic product will launch in Q3 2025, entering a market with approximately $201 million in annual U.S. sales according to IQVIA data.
  • The approval represents a key milestone for Amneal's Affordable Medicines segment, demonstrating the company's R&D capabilities in developing complex ophthalmic formulations.
  • Common adverse reactions include elevated intraocular pressure with potential glaucoma development, optic nerve damage, cataract formation, and delayed wound healing.

Subcutaneous Oncology Drug Delivery Transforms Cancer Care with FDA-Approved Formulations

Drug Approval
  • Pharmaceutical companies are increasingly developing subcutaneous formulations of existing IV oncology treatments, with recent FDA approvals marking a significant shift in cancer care delivery methods.
  • Subcutaneous administration dramatically reduces treatment times, with some therapies transitioning from 4-hour IV infusions to 10-minute injections, improving efficiency for patients and providers.
  • The shift addresses critical healthcare challenges including nursing shortages and resource constraints by enabling faster patient turnover and reducing staffing requirements per treatment.
  • Major oncology drugs including bortezomib, rituximab, daratumumab, atezolizumab, and nivolumab have successfully transitioned to subcutaneous delivery, with pembrolizumab formulation upcoming.

FDA Approves New Tablet Formulation of BRUKINSA for All Indications, Reducing Pill Burden for B-Cell Cancer Patients

Drug ApprovalOncology
  • The U.S. FDA has approved a new tablet formulation of BRUKINSA (zanubrutinib) for all five approved indications, reducing daily pill burden from four capsules to two tablets while maintaining the same 320 mg daily dose.
  • The new 160 mg tablets demonstrate bioequivalence to the existing capsules based on Phase 1 crossover studies and offer improved patient convenience with smaller size and film coating for easier swallowing.
  • BRUKINSA has achieved market leadership as the top BTK inhibitor in the U.S. and leads in new chronic lymphocytic leukemia patient starts across all therapy lines.
  • The tablet formulation will replace capsules starting in October 2025, with European regulatory approval expected later this year.

Ibrutinib (PCI-32765) in Waldenstrom's Macroglobulinemia

NCT01614821CompletedPhase 2
Dana-Farber Cancer Institute
Posted 5/1/2012

Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL

NCT01722487CompletedPhase 3
Pharmacyclics LLC.
Posted 3/1/2013

Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

NCT01109069CompletedPhase 2
Pharmacyclics LLC.
Posted 6/1/2010

Relative Bioavailability of Zanubrutinib Tablets Compared to Capsules and Effects of Food on the Pharmacokinetics of the Tablet in Healthy Adults

NCT05547399CompletedPhase 1
BeiGene
Posted 6/7/2022

Study of Ibrutinib in Patients With Symptomatic, Previously Untreated Waldenstrom's Macroglobulinemia, and Impact on Tumor Genomic Evolution Using Whole Genome Sequencing

NCT02604511CompletedPhase 2
Dana-Farber Cancer Institute
Posted 1/1/2016

Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

NCT02165397CompletedPhase 3
Pharmacyclics LLC.
Posted 7/7/2014

A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

NCT01578707CompletedPhase 3
Pharmacyclics LLC.
Posted 6/1/2012

Bioequivalence of a Zanubrutinib Tablet Compared to Capsules in Healthy Adult Participants

NCT05767398CompletedPhase 1
BeiGene
Posted 3/7/2023

FDA Approves MAVYRET as First Treatment for Acute Hepatitis C with 96% Cure Rate in Eight Weeks

Drug Approval
  • The U.S. FDA approved an expanded indication for AbbVie's MAVYRET (glecaprevir/pibrentasvir), making it the first and only oral eight-week pangenotypic treatment approved for people with acute hepatitis C virus infection.
  • The approval was supported by Phase 3 trial data showing a 96% cure rate in 286 treatment-naïve adult patients with acute HCV infection treated for eight weeks.
  • MAVYRET received FDA Breakthrough Therapy Designation for acute HCV treatment, designed to expedite development of medicines that demonstrate substantial improvement over existing therapies.
  • The expanded indication supports global clinical guidelines for universal HCV treatment and public health goals to eliminate hepatitis C as a public health problem by 2030.

Study to Evaluate Adverse Events and Change in Disease Activity in Adult and Adolescent Participants With Acute Hepatitis C Virus (HCV) Infection on Treatment With Oral Tablets of Glecaprevir (GLE)/Pibrentasvir (PIB)

NCT04903626CompletedPhase 3
AbbVie
Posted 8/24/2021

Graves Disease Pipeline Shows Promise with 10+ Therapies in Development as TED Treatments Gain Regulatory Momentum

Monoclonal AntibodyDrug Approval
  • DelveInsight's 2025 pipeline analysis reveals 8+ key companies are developing 10+ novel Graves Disease treatment therapies across various clinical development phases.
  • Recent regulatory milestones include Amgen's TEPEZZA approval by UK MHRA for thyroid eye disease and FDA's breakthrough therapy designation for Viridian's veligrotug.
  • Emerging therapies targeting IGF-1R pathway show clinical promise, with Sling Therapeutics' linsitinib demonstrating favorable safety profile in over 900 patients across 15 trials.
  • Pipeline includes diverse therapeutic approaches spanning monoclonal antibodies, small molecules, and gene therapy with multiple routes of administration under investigation.

China Approves First-in-Class Influenza Drug Onradivir Targeting Novel PB2 Protein

Drug Approval
  • China's National Medical Products Administration has approved onradivir, the world's first anti-influenza drug targeting the PB2 protein of the virus's RNA polymerase, marking a breakthrough in influenza treatment.
  • The novel drug demonstrates rapid efficacy by suppressing viral load to very low levels within 24 hours and shows low resistance development compared to existing treatments.
  • Clinical studies indicate onradivir acts faster than commonly used flu treatments oseltamivir and baloxavir marboxil in reducing symptoms and viral load in patients.
  • The approval provides a new therapeutic option for adult patients with uncomplicated influenza A, addressing a global health challenge that causes 290,000 to 650,000 deaths annually.

SIFI Merges with Faes Farma to Expand Global Access to Akantior, First Approved Therapy for Rare Eye Infection

Orphan DrugRare DiseaseDrug Approval
  • SIFI, a leading international ophthalmic company, has agreed to merge with European pharmaceutical company Faes Farma in a transaction that positions ophthalmology as approximately 20% of the combined entity's pro-forma revenue.
  • The merger will accelerate development of Akantior (polihexanide 0.08%), the first and only approved therapy worldwide for Acanthamoeba Keratitis, particularly targeting expansion into the US market where it has orphan drug designation.
  • The combined entity will leverage commercial synergies across complementary markets in Europe and Latin America, while also advancing polihexanide development for additional orphan indications including Fungal Keratitis.
  • The transaction values SIFI at a double-digit multiple of 2024 EBITDA plus regulatory and commercial milestone-based earn-outs, with closing expected in Q3 2025 subject to regulatory approvals.

US Universities Drive 87% of Academic Patents Supporting FDA Drug Approvals from 2020-2024

Drug Approval
  • US universities contributed patents supporting half of all FDA-approved drugs between 2020 and 2024, demonstrating their critical role in pharmaceutical innovation.
  • American academic institutions accounted for 87% of all university-based patents linked to FDA drug approvals during this four-year period.
  • The analysis examined patent data from the FDA's Orange Book, revealing the substantial impact of US-based research on global pharmaceutical development.
  • These findings underscore the prominence of American universities in driving medical treatment advances and pharmaceutical research efforts worldwide.

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