News

Johnson & Johnson Completes Proteologix Acquisition, Gains Bispecific Antibody Assets

June 28, 2024

Johnson & Johnson gets two bispecific antibodies in early phase development for immune-mediated diseases through its Proteologix acquisition.

Lantheus Acquires Rights to Life Molecular’s RM2 Targeting GRPR for Prostate and Breast Cancers

June 27, 2024

GRPR, or gastrin-releasing peptide receptor, is part of the bombesin G protein-coupled receptor family and has been found to be overexpressed in multiple cancers.

Kite to Evaluate Cellares’ Manufacturing Platform for Wider Use

June 27, 2024

No timetable was given for the length of the planned evaluation or when data would be available, but Kite intends to use the information to expand its manufacturing options.

AstraZeneca Lung Cancer Treatment Approved in China

June 27, 2024

Results of a Phase III trial showed that Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death associated with EGFR-mutated non-small cell lung cancer by 44%.

Novo Nordisk Aims to Invest $4.1 Billion to Expand Manufacturing Capacity in US

June 27, 2024

This $4.1 billion investment to build a second fill/finish manufacturing facility in Clayton, N.C., boosts Novo Nordisk's current 2024 investments in production to $6.8 billion.

European Commission Approves Metastatic Colorectal Cancer Monotherapy

June 27, 2024

Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.

FDA Drafts Guidance Document to Assist Sponsors with Diversity Action Plans

June 26, 2024

Diversity Action Plans are now required to be submitted by medical product sponsors after changes governed by the Food and Drug Omnibus Reform Act.

Sarepta’s Elevidys for Duchenne Muscular Dystrophy Gets Expanded FDA Approval

June 26, 2024

Sarepta Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.

CDER Gives Update on New Drugs Regulatory Program

June 26, 2024

Yoni Tyberg, associate director of the Special Program Staff in the Office of New Drugs, provided an update on efforts to modernize CDER processes.

argenx Gets FDA Nod for VYVGART Hytrulo in CIDP Indication

June 26, 2024

FDA has approved argenx's VYVGART Hytrulo for a new indication, treating chronic inflammatory demyelinating polyneuropathy.