How Do Cell Gene Therapy Requirements Differ Between FDA EMA
This article examines the similarities and differences between how the FDA and the European Medicines Agency (EMA) approach cell and gene therapies.
Source: clinicalleader.com
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Forxiga approved in EU for chronic heart failure
Forxiga (dapagliflozin) has been approved in the EU across the full LVEF spectrum for chronic heart failure.
United States United Kingdom Great Britain Astrazeneca Forxiga American Heart Association European Union
Source: europeanpharmaceuticalreview.com
Could This Indication Provide a Lift for Bristol Myers Squibb's Stock?
Bristol Myers' Sotyktu recently moved one step closer to its first approval in the European Union.
Source: fool.com
European Biosimilar Regulatory Updates | Goodwin
STADA and Xbrane Announce Approval of Ranibizumab Biosimilar in UK - On January 16, 2023, STADA Arzneimittel AG (STADA) and Xbrane Biopharyma AB (Xbrane) announced that...
United Kingdom Adalimumab Biosimilar Ranibizumab Biosimilar European Medicines Agency Committee For Medicinal Products Human Use Regulatory Agency
Source: jdsupra.com
Will These 3 Potential Blockbuster Drugs Lift Bristol Myers Squibb?
Bristol Myers Squibb has solid replacements for its blockbusters that are facing a patent cliff.
United States Bristol Myers Squibb European Commission Drug Administration European Union European Medicines Agency
Source: fool.com
ChatGPT isn't a great leap forward, it's an expensive deal with the devil | John Naughton
The new chatbot is generating a lot of hype, but we would do well to consider its human and environmental cost
Source: theguardian.com
In $94M Agreement, Royalty Pharma Acquires Royalty Interest in Entyvio
Read about Royalty Pharma's $94 million acquisition of a royalty interest in IBD therapy Entyvio from Massachusetts General Hospital’s (MGH).
Source: ibdnewstoday.com
EU Approves Yuflyma, Humira Biosimilar, for Chronic Inflammatory Diseases
The European Commission has granted marketing authorization to Yuflyma, a biosimilar to Humira (adalimumab), making it available treat chronic inflammatory diseases.
Source: ibdnewstoday.com
IBD Therapy Entyvio Approved in Europe as Subcutaneous Injection
A subcutaneous formulation of Entyvio (vedolizumab) has been approved in Europe for moderately to severely active ulcerative colitis or Crohn’s disease.
United Kingdom Adam Zaeske Takeda Pharmaceuticals Committee For Medicinal Products Human European Union European Commission
Source: ibdnewstoday.com
At-Home Entyvio Injection for Crohn's Recommended for Europe Approval
A European Medicines Agency panel recommended approval of an at-home injection of Entyvio, which is used to treat Crohn’s and ulcerative colitis.
Entyvio Vedolizumab Adam Zaeske European Medicines Agency Colitis Organisation European Commission Committee For Medicinal Products Human Use
Source: ibdnewstoday.com