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FDA Advisory Panel Unanimously Recommends Approval of Lilly's Alzheimer's Drug Donanemab

Drug Approval
  • An FDA advisory committee voted 11-0 to recommend approval of Eli Lilly's donanemab for early Alzheimer's disease, concluding that benefits outweigh risks despite safety concerns.
  • Clinical studies demonstrated that donanemab significantly reduced amyloid plaque buildup in the brain and plasma phosphorylated tau levels, key biomarkers of Alzheimer's disease.
  • If approved later this year, donanemab would become the second drug on the market to treat Alzheimer's disease, with Lilly expecting blockbuster sales potential.
  • The unanimous recommendation positions donanemab for a market showdown with existing competitor Leqembi following anticipated FDA approval.

InnoCare Advances Dual Regulatory Milestones with Tafasitamab BLA Acceptance and BCL2 Inhibitor ICP-248 Clinical Trial Approval in China

Monoclonal AntibodyDrug Approval
  • China's NMPA has accepted and granted priority review to InnoCare's biologics license application for tafasitamab plus lenalidomide combination therapy for relapsed or refractory diffuse large B-cell lymphoma patients ineligible for stem cell transplant.
  • The company received separate approval to initiate clinical trials of its novel BCL2 inhibitor ICP-248 in combination with azacitidine for acute myeloid leukemia treatment in China.
  • DLBCL represents the most common non-Hodgkin lymphoma type globally, accounting for 45.8% of all NHL cases in China, highlighting significant unmet medical need.
  • These regulatory advances strengthen InnoCare's hemato-oncology pipeline with complementary mechanisms targeting CD19 and BCL2 pathways across different blood cancer indications.

Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL

NCT02399085CompletedPhase 2
MorphoSys AG
Posted 3/29/2016

Three RSV Vaccines Now Available for Older Adults as FDA Approves Moderna's mRESVIA

Drug Approval
  • The FDA has approved three RSV vaccines for adults 60 years and older, with Moderna's mRESVIA joining GSK's Arexvy and Pfizer's Abrysvo in the market as of May 2024.
  • Clinical trials demonstrate high efficacy rates across all three vaccines, with Arexvy showing 82.6% effectiveness, Abrysvo achieving 88.9% efficacy, and mRESVIA demonstrating 83.7% protection against RSV-associated lower respiratory tract disease.
  • The vaccines employ different approaches, with Abrysvo being bivalent targeting both RSV A and B strains, Arexvy containing an adjuvant for enhanced immune response, and mRESVIA utilizing mRNA technology.
  • Pharmacists are positioned to play a crucial role in RSV vaccination efforts, given their accessibility and expertise, as nine in ten Americans live within five miles of a pharmacy.

Efficacy Study of GSK's Investigational Respiratory Syncytial Virus (RSV) Vaccine in Adults Aged 60 Years and Above

NCT04886596CompletedPhase 3
GlaxoSmithKline
Posted 5/25/2021

Study to Evaluate the Efficacy, Immunogenicity, and Safety of RSVpreF in Adults.

NCT05035212RecruitingPhase 3
Pfizer
Posted 8/31/2021

A Study to Evaluate the Safety and Efficacy of mRNA-1345 Vaccine Targeting Respiratory Syncytial Virus (RSV) in Adults ≥60 Years of Age

NCT05127434Active, Not RecruitingPhase 2
ModernaTX, Inc.
Posted 11/17/2021

Regeneron's Lynozyfic Receives FDA Approval for Multiple Myeloma with 70% Response Rate

Drug Approval
  • Regeneron's Lynozyfic (linvoseltamab-gcpt) received accelerated FDA approval for relapsed or refractory multiple myeloma patients with at least four prior treatments.
  • The first-in-class BCMAxCD3 bispecific antibody demonstrated a 70% overall response rate with 45% achieving complete response or better in the pivotal LINKER-MM1 trial.
  • The therapy features a flexible maintenance schedule that can extend to every four weeks based on patient response, potentially reducing treatment burden.
  • The approval includes a Boxed Warning for cytokine release syndrome and neurological toxicities, with availability through a Risk Evaluation and Mitigation Strategy program.

Phase 1/2 Study of REGN5458 in Adult Patients With Relapsed or Refractory Multiple Myeloma

NCT03761108RecruitingPhase 1
Regeneron Pharmaceuticals
Posted 1/23/2019

Roche's Columvi Demonstrates 41% Reduction in Death Risk in Phase III DLBCL Trial

OncologyDrug Approval
  • Roche's Phase III STARGLO study showed Columvi plus chemotherapy reduced death risk by 41% versus rituximab plus chemotherapy in relapsed/refractory diffuse large B-cell lymphoma patients.
  • The combination achieved a median overall survival of 25.5 months compared to 12.9 months for the control arm, with complete response rates of 58.5% versus 25.3%.
  • Results position Columvi as the first CD20xCD3 bispecific antibody to demonstrate survival benefit in DLBCL in a randomized Phase III trial.
  • The data will be submitted to global health authorities including FDA and EMA to support conversion from accelerated to full approval.

An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma

NCT06047080RecruitingPhase 3
Hoffmann-La Roche
Posted 9/18/2023

A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT04408638Active, Not RecruitingPhase 3
Hoffmann-La Roche
Posted 2/23/2021

Leqembi's Slow Adoption: Challenges and Progress in Alzheimer's Treatment

Monoclonal AntibodyDrug ApprovalNeurology
  • Leqembi, the first FDA-approved drug shown to slow Alzheimer's progression, has experienced slower-than-expected adoption despite its groundbreaking status in treating the disease.
  • Healthcare systems face significant implementation challenges, including establishing diagnostic protocols, monitoring systems for side effects, and navigating complex insurance coverage issues for the $26,000-per-year treatment.
  • Despite modest clinical benefits and potential side effects like brain swelling and bleeding, some patients report improvements in short-term memory, offering hope as researchers continue developing easier administration methods and complementary treatments.

FDA Grants Accelerated Approval to Krazati Plus Cetuximab for KRAS G12C-Mutated Colorectal Cancer

Drug ApprovalPrecision MedicineTargeted Therapy
  • The FDA granted accelerated approval to Krazati (adagrasib) plus cetuximab for adults with KRAS G12C-mutated locally advanced or metastatic colorectal cancer who have received prior standard chemotherapy treatments.
  • The combination therapy targets a specific genetic mutation and is approved for patients whose tumors are determined to have the KRAS G12C mutation by an FDA-approved test.
  • The most common adverse reactions include rash, nausea, diarrhea, vomiting, fatigue, and musculoskeletal pain, occurring in at least 20% of patients.
  • This approval represents a significant advancement in precision medicine for colorectal cancer patients with this specific genetic alteration.

Fresenius Kabi Launches First Actemra® Biosimilar in U.S. Market as Biosimilar Landscape Expands

Drug ApprovalOncologyMonoclonal Antibody
• Fresenius Kabi has launched Tyenne® (tocilizumab-aazg), the first biosimilar of Actemra® to enter the U.S. market, following FDA approval in March 2024 for both intravenous and subcutaneous formulations.
• Accord BioPharma received FDA approval for Hercessi™ (trastuzumab-strf), becoming the sixth Herceptin® biosimilar approved in the U.S., while Xbrane's Xlucane™ (ranibizumab) received a Complete Response Letter from the FDA.
• The expanding biosimilar market continues to challenge reference products with significant annual sales, with Actemra® generating approximately $3 billion, Herceptin® $1.77 billion, and Lucentis® $1.475 billion in 2023.

FDA Approves Pfizer's $3.5 Million Gene Therapy Beqvez for Hemophilia B Treatment

Drug ApprovalRare Disease
  • The FDA approved Pfizer's Beqvez, a one-time gene therapy for adults with moderate to severe hemophilia B, marking the company's first gene therapy approval in the U.S.
  • The treatment carries a $3.5 million price tag before insurance and rebates, making it one of the most expensive drugs in the United States.
  • Beqvez enables patients to produce factor IX protein themselves, potentially eliminating the need for regular intravenous infusions administered multiple times per week or month.
  • The therapy will compete with CSL Behring's Hemgenix, another gene therapy for hemophilia B approved in 2022 with a similar $3.5 million price point.

FDA Approves ImmunityBio's Anktiva for Bladder Cancer, Marking Major Milestone for Soon-Shiong's Immunotherapy Approach

Drug ApprovalOncology
  • The FDA has approved ImmunityBio's lead drug Anktiva for treating a common form of bladder cancer, representing a significant breakthrough after years of development and regulatory challenges.
  • Anktiva harnesses the body's natural killer cells and T-cells to fight cancer, with clinical trials showing the ability to eliminate bladder cancer cells for at least four years.
  • ImmunityBio plans to begin distributing Anktiva to healthcare providers by mid-May 2024, with the company having built a three-year stockpile of the drug during the FDA review process.

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