BioSpace News Archive

Business

Pfizer Inks Potential $1B ADC Deal with Nona, Closes Seagen Acquisition

Amid falling COVID-19 revenues, Pfizer continues to invest in antibody-drug conjugates in a deal with Nona Biosciences worth $1 billion as its $43 billion Seagen buy closed on Thursday.

December 15, 2023
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2 min read
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Tristan Manalac
Policy

Biden, Big Pharma Increasingly at Loggerheads in Run-Up to 2024 Election

President Joe Biden has long promised to stand up to Big Pharma, lower prescription drug prices and limit the power of drugmakers—a pledge he seems intent on keeping.

December 15, 2023
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3 min read
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Greg Slabodkin
Policy

EMA Committee Votes Against Renewing Marketing Authorization for GSK’s Blenrep

A European Medicine Agency panel on Friday reaffirmed its decision not to renew the conditional marketing authorization for GSK’s multiple myeloma drug Blenrep.

December 15, 2023
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2 min read
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Tyler Patchen
Policy

Sanofi, AstraZeneca Promise 230K More Doses of RSV Infant Shots for US

At the urging of the Biden administration, Sanofi and AstraZeneca are pledging 230,000 additional doses of their respiratory syncytial virus infant immunization Beyfortus in January 2024.

December 15, 2023
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2 min read
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Tristan Manalac
FDA

FDA Approves First Oral High-Risk Neuroblastoma Maintenance Therapy

Despite the lack of a randomized clinical trial to support eflornithine’s efficacy, the regulator approved US WorldMeds’ oral maintenance treatment for high-risk neuroblastoma in adults and children.

December 15, 2023
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2 min read
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Tristan Manalac
Business

Bluebird Bio Secures Deal with Large Commercial Payer for Lyfgenia Amid Price Concerns

Despite pricing concerns for bluebird bio’s FDA-approved sickle cell disease gene therapy, the biotech has inked a deal with an unnamed commercial payer “representing approximately 100 million covered lives” in the U.S.

December 15, 2023
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2 min read
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Tyler Patchen
Drug Development

MindMed Posts Positive Phase II Results for LSD-Based Treatment for Anxiety

The biotech reported topline data from a mid-stage study of MM-120, its LSD-based drug, in patients with generalized anxiety disorder.

December 15, 2023
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2 min read
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Tyler Patchen
Policy

Vertex-CRISPR’s Casgevy Gets Positive EMA Panel Opinion, Approval Decision in Q1 2024

A week after securing FDA approval, a European Medicines Agency committee has endorsed Vertex and CRISPR Therapeutics’ Casgevy for sickle cell disease and transfusion‑dependent beta thalassemia.

December 15, 2023
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2 min read
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Kate Goodwin
Policy

FDA Puts Clinical Hold on Three CARsgen Therapeutics CAR-T Candidates

The regulator placed the clinical hold on the Chinese biotech’s trio of CAR-T cell therapy candidates after an inspection of its Durham, North Carolina manufacturing facility.

December 15, 2023
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2 min read
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Tyler Patchen
FDA

FDA Approves Merck’s Welireg for Treating Renal Cell Carcinoma

Merck’s HIF-2α inhibitor Welireg has been approved by the FDA to treat advanced renal cell carcinoma after treatment with PD-1 or PD-L1 and VEGF-TKI-based therapies.

December 15, 2023
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2 min read
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Tyler Patchen