1. Scrip
  2. >>Business

AstraZeneca Hits And Misses: Trio Of EU Label Expansions But US Lynparza Review Delayed

 
• By Ayisha Sharma

The major has won two positive CHMP opinions and one EU approval for meaningful label expansions across its oncology and cardiology franchises, but a delayed US review for prostate cancer drug Lynparza has put a spanner in the works.  

Red rollercoaster against blue sky background
While Positive EU Opinions Abound, Things Are Looking Down In The US • Source: Shutterstock

AstraZeneca PLC has announced a slew of updates across its portfolio including EU nods or approvals for label expansions for several blockbuster products, but news of a delay to the US review of Lynparza for prostate cancer and a Phase III failure for Imfinzi has dulled some of the shine.

First up, the EU’s Committee for Medicinal Products for Human Use issued a positive opinion on the use of Forxiga/Farxiga (dapagliflozin) to treat the full spectrum of left ventricular ejection fraction, including heart failure with

More from Business

‘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.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By Kevin Grogan

As CEO Anderson backs high prices for innovative drugs in Europe

Stock Watch: Stock Watch: Lilly And Novo Duke Out Q1

 
• By Andy Smith

Novo Nordisk enjoyed a surprise GLP-1 agonist contracting win in the first quarter of 2025. This provided a welcome boost to its stock after it had spent the previous quarter on the back foot against rival Lilly.

Azafaros Banks Over €130m To Advance Nizubaglustat Into Phase III

 
• By Kevin Grogan

The therapy has been developed for GM1 and GM2 gangliosidoses and Niemann-Pick disease type C.

More from Scrip

Sustainability Key To ABL Bio’s Journey From ‘Good To Great’

 
• By Jung Won Shin

Helped by a recent major platform deal with GSK, South Korea's ABL Bio is aiming to build its R&D portfolio with an eye on being acquired in the future. CEO Sang Hoon Lee sat down with Scrip to explain the venture's journey so far and its ambitious roadmap.

Roche Reveals Another US Manufacturing Site As Tariff Pressures Seem To Ease

 
• By Mandy Jackson

Roche/Genentech unveiled plans for a $700m-plus manufacturing facility for weight loss drugs in North Carolina as President Trump signaled such investments could mean no tariffs for pharma.

Lilly Builds Obesity Momentum With New SURMOUNT Data Besting Novo Nordisk

 
• By Alaric DeArment

The presentation and publication of the Phase IIIb study showing greater efficacy for Zepbound over Wegovy come at a time when competition has been heating up between the two obesity medications.