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Latest From Alex Shimmings
The EU's CHMP has given the go ahead to extend the EU licence for Janssen/Genmab's Darzalex to include its use earlier in the treatment paradigm, bringing into line with the US label and its rivals.
The death of a patient during the HAVEN 1 study of Roche's investigational hemophilia product, emicizumab, may be nothing to panic about, but it is increasing concerns over its likely impact on the potential blockbuster drug's label.
Celgene is finally able to market its mainstay multiple myeloma therapy Revlimid for maintenance use after stem cell transplant, after the FDA further expanded its approved indications. The EU is set to follow suit following a CHMP positive opinion last month.
Two Canadian companies – Theratechnologies and CytoDyn – exploring the use of monoclonal antibodies in the fight against HIV presented data for their novel late-stage candidates at the recent CROI meeting in Seattle. They are aimed at patients experiencing multi-drug resistance and represent a change in this mature therapy area dominated by small-molecule oral products.
Data from ViiV Healthcare and Janssen's SWORD study point the way to a two-drug future in HIV for Tivicay/Edurant, but will doctors want to rock the boat, especially with Gilead's bictegravir impressing in Phase II?
Acorda's $525m purchase of Civitas in 2014 is now set to bear fruit, with new Phase III data for an inhaled formulation of levodopa, the main attraction of the deal, looking strong enough both to warrant approval filings and please payors.