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AstraZeneca’s Calquence Catches Up With Imbruvica’s CLL Claim

 
• By Leah Samuel

AZ is counting on Calquence’s safety profile to gain ground against AbbVie/J&J’s blockbuster BTK inhibitor Imbruvica.

FDA’s broad approval for AstraZeneca PLC PLC’s Calquence (acalabrutinib) for chronic lymphocytic leukemia and small lymphocytic leukemia for any line of treatment gives the company the best shot possible at gaining share from AbbVie Inc./Johnson & Johnson’s market leading Imbruvica (ibrutinib).

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J&J’s Imaavy Approval Is The Starting Line For Pipeline-In-A-Product Strategy

 
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The company’s FcRn inhibitor nipocalimab was approved by the US FDA for generalized myasthenia gravis (gMG), where it will join a competitive market.

Pipeline Watch: Five Approvals And One Phase III Readout

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Merck KGaA Seals SpringWorks Buy

 
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The German group is paying $3.9bn to get hold of the US firm and its two approved products.

Akeso Wins US Approval For PD-1 Antibody In NPC, Partly On US Data

 
• By Dexter Jie Yan

Akeso’s penpulimab will be the second to hit the US market for nasopharyngeal carcinoma, but the first to win FDA approval for the indication based on clinical findings in US patients.

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Zelluna Believes Its TCR Tech Can Unlock Natural Killer Cell Potential

 
• By Andrew McConaghie

While CAR-NKs have pivoted towards autoimmune disease, the Norwegian biotech believes its unique platform can deliver in oncology

AstraZeneca COPD Drug Breztri Breezes Through Asthma Trials

 
• By Kevin Grogan

The triple therapy improves lung function in the Phase III KALOS and LOGOS studies

Transient FY26 For Syngene But Momentum In China +1 Projects

 
• By Anju Ghangurde

As biopharma derisks its business with China ‘rebalancing’ strategies, Syngene could convert majority of such pilots into full program contracts amid a challenging FY2025. The CRDMO also expects business discussions pertaining to a newly acquired US biologics site to mature into commercial opportunities.