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Latest From Biogen, Inc.
US FDA Alzheimer Guidance Update Reflects Changes In Biomarkers – And Leadership
Latest update to draft guidance on early Alzheimer’s drug development is the third iteration of a document first published in 2013. The history of the guidance is a reflection of structural and leadership changes in the neurology review team at FDA.
Finance Watch: Mega-Rounds Around The World As VCs Spread The Wealth
Private Company Edition: After US-based Alumis and Sionna raised $259m and $182m, respectively, in series C rounds, Tubulis in Munich, Germany brought in €128m ($138.8m) in series B2 cash, while Rakuten – with offices in the US, Europe and Asia – closed a $119m series E round.
All Eyes On Pricing Model As EU Crunch Time Nears For First Ophthalmic Bevacizumab
If Outlook Therapeutics’ Lytenava secures EU approval for wet AMD, the company says it expects to price the drug as a lower cost alternative to biosimilars and premium branded products for the condition, and higher than off-label compounds.
EMA Decision Time For Aztreonam-Avibactam; High-Stakes Meeting For Lecanamab
The European Medicines Agency is this week deciding whether a number of new drugs should win EU approval.
Company Information
- Industry
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Pharmaceuticals
- Specialty Pharmaceuticals
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Drug Delivery
- Macromolecule
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Biotechnology
- Gene Therapy, Cell Therapy
- Large Molecule
- Other Names / Subsidiaries
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- Biogen Idec
- Convergence Pharmaceuticals Ltd
- Nightstar Therapeutics plc
- Stromedix, Inc.
- Syntonix Pharmaceuticals
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