Tag Archives: AstraZeneca
First Orphan Launch a Challenge for AstraZeneca
Four months after AstraZeneca received FDA approval for vandetanib, a treatment for inoperable medullary thyroid cancer, the company announced the drug’s trade name: Caprelsa. FDA said other proposed names – Zactima, for example – too closely resembled other currently marketed proprietary names.
Getting FDA approval on a brand name for vandetanib, AstraZeneca’s very first orphan drug, isn’t [...]
Posted in FDA, Marketing, Safety, Strategy, patient education Also tagged Cancer, Launch, Orphan Drugs, Sales, Ultra Orphan Leave a comment
Two 'Most Promising' New Drugs Face Setbacks in US
Two of the drugs named “most promising” in Thomson Reuters’ recent quarterly report hit snags in the US, despite European approval.
Those two products – AstraZeneca’s Brilique (Brilinta in the US), a blood thinner, and Pharming’s Ruconest (Rhucin in the US) – were held up during FDA’s review process. Brilique (ticagrelor), AstraZeneca’s leading pipeline drug, was [...]
Posted in FDA, Global, R&D, Regulatory, Sales Also tagged Brilique, FDA, Pharming, Ruconest, Thomson Reuters Leave a comment
MedImmune Bets Its Fate on “Biobetters”
AstraZeneca’s biologics shop makes a decisive move in the biosimilars market.
MedImmune, the biologics shop bought by AstraZeneca (AZ) for a staggering $15 billion in 2007 promising one new drug a year for the foundering British firm, has made precious little news since the deal. But all of a sudden the post-Labor Day wires were crackling [...]
Europe: Resisting the Anticompetitive Crusade
It’s been another rocky few weeks for pharma in Europe. Particularly for big brand name companies. But necessity is proving the mother of invention, says Pharm Exec’s Brussels correspondent, Reflector.
AstraZeneca suffered a serious setback at the start of July when the European General Court ruled that it had illegally prevented generic competition. The case dates [...]
Posted in Strategy Also tagged Belgium, Commission, Competition law, European Commission, European Union, Generic drug, Pharmaceutical drug Leave a comment

UK Reacts to AZ Job Cuts