Key Developments in Biosimilars and Pharmaceuticals in 2024
2024 has seen significant advancements and approvals in the biosimilars and pharmaceutical sectors, including the launch of Wegovy® in Australia, new indications for Opdivo®, and approvals for biosimilars in Canada and Europe. Additionally, there have been notable developments in clinical trials and legal disputes over patents.
Significant Developments in Biosimilars and Pharmaceuticals in 2024
2024 has seen major advancements and approvals in the biosimilars and pharmaceutical sectors, including the launch of new treatments, regulatory approvals, and significant financial performances by leading companies.
Lasofoxifene Shows Promise in Neoadjuvant Breast Cancer Treatment: I-SPY 2 Trial
Lasofoxifene demonstrated a strong tolerability profile and promising Ki67 suppression in a Phase 2 I-SPY 2 trial arm, supporting further exploration in the neoadjuvant setting.
Veloxis Pharmaceuticals' Transplant Candidate VEL-101 Receives Official Name "Pegrizeprument"
The USAN Council has approved "pegrizeprument" as the nonproprietary name for Veloxis Pharmaceuticals' lead transplant candidate VEL-101, marking a significant milestone in the drug's development pathway.
NRx Pharmaceuticals Advances NRX-100 and NRX-101 for Suicidal Depression, Eyes 2024 NDA Filings
NRx Pharmaceuticals is on track to file NDAs for NRX-100 (IV Ketamine) and NRX-101 (Oral D-Cycloserine/Lurasidone) by year-end 2024 for treating suicidal ideation and bipolar depression.
Glenmark Pharmaceuticals Reaches $7M Settlement in US Antitrust Lawsuits Over Cholesterol Drugs
Glenmark Pharmaceuticals has agreed to pay $7 million to settle antitrust lawsuits with three major healthcare entities - Humana, Centene, and Kaiser - over generic cholesterol medications Zetia and Vytorin.
Vertex Pharmaceuticals Incorporated Faces Setbacks in Clinical Trials
Vertex Pharmaceuticals Incorporated experienced a decline in stock value due to setbacks in clinical trials for its new therapeutic, suzetrigine, aimed at treating chronic pain. Despite this, the company remains optimistic about its future trials and continues to focus on its cystic fibrosis treatments and other pipeline assets.
Perspective Therapeutics and PMV Pharma Provide Clinical Trial Updates
Perspective Therapeutics' VMT-α-NET program shows promising early results in neuroendocrine tumors, with no dose-limiting toxicities observed in Phase 1/2a trials.
Lasofoxifene Shows Promise in Early Breast Cancer Treatment, I-SPY 2 Trial Data Reveal
Lasofoxifene demonstrates a strong tolerability profile and promising Ki67 suppression in a Phase 2 study, supporting further exploration in the neoadjuvant setting.
Vanda Pharmaceuticals Reports Revenue Increase and Advances Pipeline in Q3 2024
Vanda Pharmaceuticals reported a 23% increase in Q3 2024 revenues, reaching $47.7 million, driven by sales of Fanapt, HETLIOZ, and PONVORY.
Elite Pharmaceuticals Launches Generic Percocet for Moderate to Severe Pain Management
Elite Pharmaceuticals has launched its generic version of Percocet® (oxycodone hydrochloride and acetaminophen tablets) in three strengths, targeting a market with annual sales of approximately $317 million.
Cantex Pharmaceuticals' Azeliragon Receives FDA Orphan Drug Designation for Breast Cancer Brain Metastasis
Cantex Pharmaceuticals' azeliragon has been granted FDA Orphan Drug Designation for treating brain metastasis from breast cancer, addressing a critical unmet need.
Algernon Pharmaceuticals Secures European Patent for Repirinast in Kidney Disease Treatment
Algernon Pharmaceuticals has received a notice of allowance from the European Patent Office for Repirinast (NP-251) in chronic kidney disease treatment, with patent protection extending through 2038.
Conduit Pharmaceuticals Secures Japanese Patent for AZD1656 Glucokinase Activator Targeting Autoimmune Disorders
The Japan Patent Office has granted Conduit Pharmaceuticals a composition of matter patent for AZD1656, a Glucokinase Activator targeting autoimmune disorders including Lupus and ANCA Vasculitis.
Pfizer Acquires Amplyx Pharmaceuticals to Advance Novel Antifungal Development
Pfizer has acquired Amplyx Pharmaceuticals, gaining rights to fosmanogepix, a novel Phase 2 antifungal compound that could address drug-resistant fungal infections with mortality rates of 30-80%.
Amylyx Pharmaceuticals Appoints Dan Monahan as Chief Commercial Officer to Spearhead Avexitide Launch
Amylyx Pharmaceuticals has appointed Dan Monahan as Chief Commercial Officer to lead the commercialization of their product portfolio.
Qualigen Therapeutics Announces Public Offering to Advance Cancer Programs
Qualigen Therapeutics is offering 14.7 million shares of common stock at $0.13 per share to fund operations and cancer drug development.
CERO Therapeutics' CER-1236 Receives FDA Clearance for Clinical Trials
CERO Therapeutics received FDA clearance for its IND application for CER-1236, a genetically engineered human immune cell therapy, on November 15, 2024.
Tenax Therapeutics' Levosimendan Shows Promise in Pulmonary Hypertension with Heart Failure
Tenax Therapeutics is developing levosimendan for pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF), a condition affecting over 2 million U.S. patients.
Annovis Bio's Buntanetap Shows Promise in Neurodegenerative Disease Treatment
Annovis Bio's Buntanetap is currently in Phase II/III clinical trials for treating mild to moderate Alzheimer's and early Parkinson's, showing potential cognitive benefits.