Paroxysmal Nocturnal Hemoglobinuria

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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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crovalimab-for-pnh-treatment
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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Pharma News for GSK, Gilead, CSL, CymaBay
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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AstraZeneca Strengthens Presence in PNH Treatment with Voydeya in Japan: World’s First Approval

A month following Novartis’ foray into the paroxysmal nocturnal hemoglobinuria (PNH) treatment domain, AstraZeneca strengthens its position in this field as its latest contender, Voydeya, secures a groundbreaking approval in Japan. Voydeya (danicopan), an innovative oral factor D inhibitor, has received approval fr...

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Pharma News for Exelixis, AstraZeneca, Kyverna
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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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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Pharma News and Updates for Akero Chiesi Pfizer
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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Top Most Expensive Drugs in the US Healthcare Market
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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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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Cost ineffective Orphan Drugs limit the access

Rare diseases are mostly serious, chronic and life-threatening, associated with both psychological as well as financial burdens. In addition, only a few of them have effective drug treatment available. The European Union (EU) definition of a rare disease is one that affects fewer than 5 in 10,000 people. These affe...

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