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AZ's Lynparza PARP Lead Likely To Lengthen With FDA Priority Review

 
• By Kevin Grogan

Despite suffering a setback at the hands of NICE, AstraZeneca's ambitious plans for Lynparza have been boosted by the FDA agreeing to speed up a review of the recent SOLO-1 data which took ESMO by storm last month.

Speedboats
Lynparza pulling away from class rivals • Source: Shutterstock

AstraZeneca PLC's grip on the leadership of the PARP inhibitor class has tightened with the news that the FDA is carrying out a priority review on Lynparza (olaparib) as a first-line maintenance treatment for newly diagnosed ovarian cancer patients with a BRCA mutation.

The agency has accepted a supplemental New Drug Application for priority review for the use of Lynparza in the aforementioned group of newly diagnosed patients who were in complete or partial response following first-line standard platinum-based chemotherapy

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Merck’s Welireg Adrenal Tumor Rollout Targets Specialized Centers

 
• By Alaric DeArment

The drugmaker won US FDA approval for the HIF-2α inhibitor in pheochromocytoma and paraganglioma, a rare cancer of the adrenal glands, in adolescents and adults.

China Biopharma Podcast

 
• By Dexter Jie Yan and Xu Hu

Join our China-based editors Dexter Yan and Xu Hu in this Chinese-language podcast looking at some of their recent interviews and other key coverage.

iTeos/GSK To Terminate Collaboration After TIGIT Trials Flop

 
• By Alaric DeArment

Belrestotug is the latest anti-TIGIT candidate to fail to meet expectations. iTeos said it will pursue strategic alternatives.

‘Market Developments’ Persuade Galapagos To Rethink Spin-Off

 
• By Andrew McConaghie

CEO Paul Stoffels exits early to be succeeded by Henry Gosebruch, who will now consider ‘all options’ for the Belgian firm as it tries to claw back investor confidence.

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Leo Roars To A Profit In Q1 As Adbry Grows In US

 
• By Kevin Grogan

The Danish firm's atopic dermatitis drug is holding its own despite strong competition from Sanofi/Regeneron’s Dupixent.

Multiple Launches Help Lilly’s Japan Growth

 
• By Ian Haydock

Lilly saw solid growth for its business in Japan last year on the back of several new launches and is building its obesity and Alzheimer's portfolios in the country.

Novo Nordisk Looks To Septerna For Oral Obesity Options

 
• By Mary Jo Laffler

Deal Snapshot: The Danish drugmaker is partnering with GPCR drug discovery expert Septerna to develop multiple small molecules for cardiometabolic targets.