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VENUS II Paves Way For Allergan's Ulipristal NDA In Uterine Fibroids

 
• By Emily Hayes

Ulipristal meets all primary and secondary endpoints in the pivotal VENUS II study, supporting an NDA for uterine fibroids in the second half of 2017.

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Allergan PLC/Gedeon Richter Ltd. are on track for a planned NDA filing of oral ulipristal acetate for the treatment of uterine fibroids in the second half of this year, after releasing positive Phase III data on Jan. 17.

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Arbele Leverages Rights As It Drugs Proprietary CDH17 Target

 
• By Dexter Jie Yan

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Enhertu Takes The First-Line Throne In HER2 Metastatic Breast Cancer

 
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AstraZeneca and Daiichi’s DESTINY-Breast09 trial testing Enhertu with pertuzumab versus standard of care showed a statistically significant and meaningful PFS improvement.

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The IL-4/IL-13 inhibitor has been approved in the US as the first targeted therapy in over a decade for chronic itching.

In Brief: BriaCell’s Breast Cancer Cell Therapy Boosts Survival In Phase II

 
• By Sushmita Panda

BriaCell announced its cell therapy Bria-IMT plus checkpoint inhibitors bested Gilead’s Trodelvy in a Phase II trial in HR+ breast cancer; a Phase III trial is enrolling.

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China’s Biotech Stocks Proved More Resilient Than US’s Amid Market Turmoil

 
• By Andrew McConaghie, Edwin Elmhirst, and Dexter Jie Yan

Start-ups from China dominated the fastest-growing share prices for mid-cap biopharma companies in Q1, while the biggest decliners were mainly US firms.

Henlius In David Versus Goliath Race With Pfizer For First PD-L1 ADC

 
• By Dexter Jie Yan

While Henlius Biotech’s PD-L1-targeting antibody-drug conjugate HLX43 is struggling to catch up with Pfizer’s PF-08046054, the global frontrunner in the space, a key differentiation of the China-originated asset could lie in PD-L1-negative patients.

AstraZeneca Logs Japan Growth Despite Price Cuts

 
• By Lisa Takagi

AstraZeneca logs growth in Japan despite a big reimbursement price cut for one of its top sellers and expects 40 approvals in the country over the next six years.