Tarceva filed for first-line lung cancer in EU, USA
Roche, Genentech and OSI Pharmaceuticals have submitted applications to get expanded approval for the oncology blockbuster Tarceva on both sides of the Atlantic.
Read MoreAuthor: Kevin Grogan
FDA advisors recommend approval of Bayer/J&J’s Xarelto
Bayer and Johnson & Johnson have received a major boost with the news that panellists at the US regulator have recommended approval of the anticoagulant Xarelto, despite concerns over bleeding and potential liver damage.
Read MoreCHMP turns down Gilead’s cystic fibrosis drug
The latest set of opinions from the European Medicines Agency’s Committee for Medicinal Products for Human Use include good news for Novartis and Genzyme and setbacks for Gilead Sciences and Sanofi-Aventis.
Read MoreGSK sells part of its stake in Quest for $256 million
GlaxoSmithKline has further reduced its stake in the USA’s Quest Diagnostics and netted $256 million in the process.
Read MoreSchering-Plough withdraws Cylatron melanoma filing in EU
The European Medicines Agency says that it has been formally notified by Schering-Plough that the company is withdrawing a submission to get the green light for Cylatron for melanoma.
Read More- FDA approves new high dose Spinraza regimen for SMA
- Viridian reports positive results from elegrobart phase 3 trial
- Cure Parkinson’s convenes expert panel to assess £2 million combination therapy funding call
- Kygevvi approved in Europe as first treatment for TK2d
- Tozorakimab shows significant benefit in two major COPD trials
