Paroxysmal Nocturnal Hemoglobinuria
Apr 16, 2024
Roche’s Columvi Phase III STARGLO Trial; Novartis’ Fabhalta Latest Data; Vertex’s Alpine Immune Sciences Acquisition; Telix Pharmaceuticals’ TLX101-CDx Fast Track Designation; NovelMed’s NM5072 Orphan Drug Designation
Roche's Columvi Achieves Primary Endpoint of Prolonged Overall Survival in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Phase III STARGLO Trial Roche reported that the Phase III STARGLO trial successfully achieved its main goal of improving overall survival. The research revealed that in...
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Apr 02, 2024
AstraZeneca’s Voydeya FDA Approval; Akebia’s Vafseo FDA Approval; Bristol Myers Squibb’s Phase III YELLOWSTONE Trial Update; Astellas’ IZERVAY FDA Approval; AstraZeneca’s Truqap and Faslodex MHLW Approval
Voydeya Receives FDA Approval as Supplemental Treatment with Ravulizumab or Eculizumab for Managing Extravascular Hemolysis in Adult Patients with PNH Voydeya (danicopan) has received approval in the United States for use alongside ravulizumab or eculizumab in treating extravascular hemolysis (EVH) in adults dia...
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Mar 26, 2024
Regeneron’s Odronextamab BLA; Novo Nordisk’s Cardior Pharmaceuticals Acquisition; Novartis’ Fabhalta CHMP Approval; Idorsia’s TRYVIO FDA Approval; AbbVie’s Landos Biopharma Acquisition
Regeneron Updates Progress on Biologics License Application for Odronextamab Regeneron Pharmaceuticals, Inc. has announced that the FDA has issued Complete Response Letters (CRLs) regarding the Biologics License Application (BLA) for odronextamab in cases of relapsed/refractory (R/R) follicular lymphoma (FL) and...
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Feb 16, 2024
Will Roche’s Crovalimab An Answer to AstraZeneca PNH Treatment Drugs?
China has become the first nation to approve Roche’s crovalimab, a paroxysmal nocturnal hemoglobinuria (PNH) treatment. Unlike AstraZeneca’s infused treatments Soliris and Ultomiris, crovalimab is administered subcutaneously. Developed by Roche’s subsidiary Chugai Pharmaceutical, crovalimab is a humanized complemen...
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Feb 13, 2024
GSK Receives FDA Fast Track Designation for Bepirovirsen; Gilead to Acquire CymaBay Therapeutics; CSL Announces Top-line Results from the Phase III AEGIS-II Trial; Ruxoprubart Scores FDA Orphan Drug Designation for PNH Treatment; CymaBay Announces FDA Acceptance of NDA and Priority Review for Seladelpar; Biogen Received European Commission Approval for SKYCLARYS
GSK Receives FDA Fast Track Designation for Bepirovirsen in Chronic Hepatitis B GSK plc has revealed that the US Food and Drug Administration (FDA) has awarded Fast Track status to bepirovirsen, an experimental antisense oligonucleotide (ASO) designed to treat chronic hepatitis B (CHB). Fast Track designation ai...
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Jan 23, 2024
BMS, and Exelixis’s Opdivo + CABOMETYX in First-Line Advanced Renal Cell Carcinoma; AIRSUPRA Now Available as the First and Only FDA-approved Anti-inflammatory Rescue Option for Asthma; AstraZeneca’s Voydeya Receives First-ever Regulatory Approval; EMA Grants ODD to GC Biopharma’s Sanfilippo Syndrome (Type A) Treatment; FDA Approves NRx Pharma’s IND Application of NRX-101; FDA Fast Track Designation to Kyverna’s KYV-101
Opdivo in Combination with CABOMETYX Demonstrates Long-Term Survival Benefits After Four Years of Follow-Up in the CheckMate -9ER Trial in First-Line Advanced Renal Cell Carcinoma Bristol Myers Squibb and Exelixis, Inc. have released the four-year follow-up findings from the CheckMate -9ER trial, which investiga...
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Dec 18, 2023
The Expanding Market of Complement Inhibitors
The development of complement inhibitors has been growing rapidly over the years, and it has proved to be one of the breakthroughs in various therapeutic areas. These inhibitors act on the dysregulated complement system, a group of proteins that forms an essential part of innate immunity. This system comes into eff...
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Sep 20, 2022
AstraZeneca’s Danicopan Trial; CHMP Recommends Sanofi/AstraZeneca’s nirsevimab; Akero’s NASH Drug Trial; FDA Grants Orphan Drug Status to SY-5609; BMS’s Opdivo Trial Results; Pfizer to File for FDA Approval for Meningitis Vaccine; EMA Orphan Drug Designation to CAN-2409; FDA Starts Priority Review of Chiesi ‘s velmanase alfa
AstraZeneca’s Danicopan Shows Positive Results in Phase III Trial Danicopan, an oral Factor D inhibitor developed by AstraZeneca, was expected to fail a phase II trial in rare kidney disease in 2020, but a new readout could revive the drug. Danicopan (ALXN2040) has demonstrated efficacy as an adjunct treatment f...
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Apr 20, 2022
Top 12 Most Expensive Drugs in the US Healthcare Market
Drug pricing is one of the hottest topics in the healthcare segment. Several arguments have been put forward by people, governments, healthcare companies, and other organizations in favor of and against expensive medicines. Some of the drugs are so expensive that they are nearly out of reach of the common people. H...
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May 18, 2021
InnoCare’s Trial In China; Sanofi/GSK COVID-19 Vaccine; Apellis’s Empaveli for PNH; LianBio, Landos Collab
InnoCare Receives Go-ahead for Clinical Trial of TYK2 Inhibitor ICP-332 in China InnoCare, a biopharma firm developing novel therapies for the treatment of cancer and autoimmune diseases, today announced the approval of Phase I clinical trial of its novel TYK2 (Tyrosine Kinase 2) inhibitor, ICP-332, by the China...
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