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BioWorld - Thursday, December 25, 2025
Home » Topics » Europe, BioWorld

Europe, BioWorld
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EU flag, pills, syringe

46 NCEs, 28 biosimilars among 114 drugs cleared by EMA in 2024

Jan. 16, 2025
By Nuala Moran
The EMA recommended the highest number of approvals in the last 15 years in 2024, giving the nod to 114 drugs. That is amongst the highest number in the 30 years of the agency’s existence, said Steffen Thirstrup, the EMA’s chief medical officer.
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Two arrows in opposite directions

Galapagos splits, keeps cell therapies; spinout takes small molecules

Jan. 13, 2025
By Nuala Moran
Galapagos NV is abandoning its small molecule roots to focus on cell therapy and at the same time splitting in two, with the spinout company, dedicated to acquiring a portfolio of assets, taking the lion’s share of the capital.
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Gilead, Leo Pharma join in $1.7B deal for STAT6 program

Jan. 13, 2025
By Nuala Moran
Gilead Sciences Inc. is moving further into inflammatory diseases in a potential $1.7 billion deal with Leo Pharma A/S around a preclinical oral signal transduction and activator of transcription 6 (STAT6) program that the Danish dermatology specialist has been working on since 2018.
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Lilly’s ‘timely’ $2.5B Scorpion deal; GSK pays $1B up front for Idrx

Jan. 13, 2025
By Jennifer Boggs
Joining the dealmaking spree to kick off the 2025 J.P. Morgan Healthcare Conference, Eli Lilly and Co. announced it was picking up an early clinical-stage PI3Kα inhibitor program from Scorpion Therapeutics Inc. in a deal that could be worth up to $2.5 billion, while GSK plc is adding to its cancer pipeline with the acquisition of Idrx Inc. for $1 billion up front.
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Blood samples in lab

Proteomics study explores how protein changes influence disease

Jan. 10, 2025
By Nuala Moran
Fourteen global pharma companies are getting together to conduct the largest proteomics study to date, analyzing 600,000 blood samples held in the UK Biobank to assess the levels of 5,400 different proteins.
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Bladder cancer illustration

Pfizer’s PD-1 inhibitor hits endpoint in BCG-naïve bladder cancer

Jan. 10, 2025
By Jennifer Boggs
Though Pfizer Inc.’s work on a PD-1-targeting antibody has trailed far behind that of its fellow big pharmas, the company could be the first to market in treatment-naïve, high-risk non-muscle invasive bladder cancer on the back of solid phase III data showing subcutaneously administered sasanlimab hit its endpoint of event-free survival. Pfizer anticipates meeting with regulatory agencies to discuss potential filings for what could be the first new treatment for that NMIBC population in decades.
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Maat hits its phase III endpoint in graft-vs.-host disease

Jan. 9, 2025
By Lee Landenberger
Top-line data from Maat Pharma SA’s phase III study of MaaT-013, an enema microbiome ecosystem therapy for acute graft-vs.-host disease, hit its primary endpoint. The milestone has prompted the company to think about filing an MAA submission for the treatment in Europe sometime in the middle of 2025, which is earlier than it had anticipated.
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Illustration of double helix
Newco news

Taking on gene delivery, Coave raises $33M series A

Jan. 9, 2025
By Nuala Moran
Coave Therapeutics SA has completed the transition to becoming a genetic medicines specialist, after divesting its single ophthalmology program and raising $33 million in a series A round.
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Green, blue, gray dollar signs
Newco news

Verdiva joins crowded GLP-1 space, launches with $411M series A

Jan. 9, 2025
By Nuala Moran
New Anglo/U.S. obesity and cardiometabolic specialist Verdiva Bio Ltd. has launched with a massive $411 million series A and a portfolio of GLP-1 and amylin agonists in-licensed from China.
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Antibody-drug conjugate illustration

Araris signs $780M deal with Chugai for multi-warhead ADCs

Jan. 8, 2025
By Nuala Moran
The wheels of the antibody-drug conjugate (ADC) juggernaut keep on turning, with Araris Biotech AG announcing a deal with a headline value of $780 million to apply its multi-payload linker technology to generate novel ADCs for Chugai Pharmaceutical Co. Ltd.
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