BioSpace News Archive

External view of AstraZeneca's headquarters building in Silicon Valley

AstraZeneca Looks to Differentiate in Kidney Disease Space Despite Setback: GlobalData

While AstraZeneca discontinued its Phase IIb trial for tozorakimab, the pharma’s zibotentan—if approved—could be “an optimal treatment of choice” for patients with diabetic kidney disease, finds a new report from GlobalData.

February 20, 2024

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2 min read

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Tyler Patchen

Pictured: FDA sign at Washington D.C. headquarters

Drug Development

FDA Puts Clinical Hold on RAPT Therapeutics’ Lead Candidate in Two Trials

The regulator has placed a clinical hold on RAPT Therapeutics’ drug zelnecirnon, which was being investigated in atopic dermatitis and asthma, after a patient experienced liver failure.

February 20, 2024

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2 min read

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Tyler Patchen

Pictured: 3D illustration of antibody-drug conjugates with their toxic payloads

Job Trends

Daiichi Sankyo Drops $1B to Boost ADC Manufacturing Capacity at German Site

With the investment in the plant, Daiichi Sankyo is looking to create new laboratories for its antibody-drug conjugates used to develop and manufacture therapies for breast, lung and stomach cancers.

February 20, 2024

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2 min read

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Tristan Manalac

Pictured: AstraZeneca signage at its office in Sweden

Drug Development

AstraZeneca’s Tagrisso Continues NSCLC Streak with New Phase III Data

In a late-stage study, Tagrisso induced a “statistically significant and highly clinically meaningful improvement” in progression-free survival in patients with unresectable stage III, EGFR-mutated non-small cell lung cancer.

February 20, 2024

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2 min read

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Tristan Manalac

Pictured: Eli Lilly World Headquarters/iStock, jet

Business

Lilly Edges Out J&J to Top 20 BioPharma Market Cap List for 2023

Two surprise companies, Vertex Pharmaceuticals and Regeneron Pharmaceuticals, made GlobalData’s list with 41.4% and 21.8% market capitalization growth, respectively.

February 20, 2024

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3 min read

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Kate Goodwin

Pictured: A collage of M&A elements/ Nicole Bean f

Deals

Opinion: 2024 Will Be a Buyers’ Market in Biopharma. It Already Is.

Mergers and acquisitions are trending upward as Novo Nordisk, Gilead, and Johnson & Johnson kick off the year with big deals. AI and other scientific advances will likely be the focus of M&As yet to come.

February 20, 2024

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5 min read

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Michael J. Lerner

Pictured: Eli Lilly's biotechnology center in San

Policy

EU to Review Lilly’s Multi-Dose Pen for Mounjaro on Heels of UK Launch

A week after Britain’s debut of the four-week Kwikpen, a European Medicines Agency panel is slated to review Eli Lilly’s multi-dose, pre-filled pen injector for diabetes drug Mounjaro.

February 20, 2024

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2 min read

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Tristan Manalac

Pictured: Pfizer office at its South San Francisco

Policy

Pfizer’s Ulcerative Colitis Drug Velsipity Approved by European Regulators

The European Commission granted marketing authorization in the EU to treat patients 16 years of age and older with moderately to severely active ulcerative colitis.

February 20, 2024

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1 min read

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Tyler Patchen

Drug Delivery

Iovance wins with Amtagvi and the ADC train chugs on

This week Lori, Greg and Tyler discuss the ⁠Accelerated Approval of Amtagvi⁠, the first one-time cell therapy for solid tumors and the first TIL therapy; the ⁠FTC and HHS probe⁠ into generic drug shortages and some recent ADC-focused raises from ⁠ProfoundBio⁠ and ⁠Firefly Bio⁠.

February 20, 2024

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1 min read

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Lori Ellis

Business

Axsome Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders, today announced reported financial results for the fourth quarter and full year of 2023.

February 20, 2024

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17 min read