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Latest From AstraZeneca PLC

Lilly’s Cyramza Wins Slim Nod, But Steba’s Tookad Falls Hard At US FDA Panel

Oncologic Drugs Advisory Committee votes 6-5 that ramucirumab’s benefit/risk profile is favorable in first-line lung cancer, but 13-2 that pivotal trial data do not support approval of Steba’s vascular-targeted, photodynamic therapy for low-risk prostate cancer.

Advisory Committees Drug Review

New Indications For Diabetes Drugs Under The Spotlight At EMA

Janssen and AstraZeneca are among a raft of companies that might this week find out whether the European Medicines Agency will recommend approval of their products for expanded therapeutic indications.

Drug Review Europe

Deal Watch: Genentech Sees Bicycle As Route To Novel Targeted Cancer Immunotherapies

Genentech pays $30m up front in a collaboration with Bicycle in a deal that could bring the UK biotech roughly $1.7bn in total. Also, deals involving Nimble, Seattle Genetics, Five Prime, Fresenius, Vifor, Yuhan, Imnewrun, Paratek, Almirall, MBD, AzothBio, Norgine, Faes, Aspen Pharmacare, Swixx.

Deals Business Strategies

Expanded Lung Cancer Claim For Lilly’s Cyramza Faces US FDA Scrutiny

Oncologic Drugs Advisory Committee will consider whether a statistically significant benefit on progression-free survival, but no survival advantage, is enough to secure a first-line lung cancer indication for ramucirumab.

Advisory Committees Drug Review
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