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AstraZeneca PLC

http://www.astrazeneca.com

Latest From AstraZeneca PLC

Secura’s Copiktra: Trial Design, Shifting Standard Of Care Could Spell The End For Third-Line CLL/SLL

In concluding benefits do not outweigh risks in the drug’s current indication, US FDA advisory committee members cite concerns about survival data from the Phase III DUO trial, as well as the drug’s toxicities, safety issues with the PI3K inhibitor class, and the changing treatment landscape for chronic lymphocytic leukemia and small lymphocytic lymphoma.

Advisory Committees Post Market Regulation & Studies

Finance Watch: Rivus Raises $132m In Series B Cash To Fund Obesity Drug Trials

VC funding slowed recently, but public company financings kept up a brisk pace with follow-on public offerings for Allakos and Alpine, private placements for Ventyx and Syros, and Albireo’s royalty deal. In restructuring updates, Biogen raised $592m in a real estate deal and Acerus is assessing options.

Financing Growth

AstraZeneca Pulls Plug On Ionis’ PCSK9 Candidate

While the Phase IIb SOLANO trial of ION449 met its primary endpoint, AstraZeneca had set a high bar of 70% LDL cholesterol reduction for competitiveness that the study did not hit.

Clinical Trials Business Strategies

Poziotinib Fails To Get FDA Panel Support Though Members Not As Dubious As Agency

Agency’s recent approval of Enhertu, which has better response rate, sways some panel members to vote against Spectrum’s NSCLC drug. FDA’s Pazdur compares poziotinib’s dosing uncertainty to ‘building a house on quicksand.’

Advisory Committees Drug Review
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