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Growth and Advancements in Fill/Finish
Employing novel technologies and more patient-centric approaches
Delving into Biopharmaceutical Development and Manufacturing
Quality Considerations in Changing Excipient Providers
June 28, 2024
Vabysmo, already approved for patients with RVO in the US and Japan, would be the first bispecific antibody treatment for the condition in Europe.
The typical cycle of ceasing and then reinitiating fremanezumab treatments may actually result in increased monthly migraine days, the study said.
Johnson & Johnson gets two bispecific antibodies in early phase development for immune-mediated diseases through its Proteologix acquisition.
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.
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.
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%.
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.
Fruzaqla was previously approved for use in patients with metastatic colorectal cancer in the US in November 2023.
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 Therapeutics received expanded approval from FDA for Elevidys in the treatment of DMD in non-ambulatory patients as ell as ambulatory patients.