The US FDA issues Biocon a Form 483 with two observations, including failure to establish proper aseptic practices and lack of follow-up on data discrepancies.
As technology has advanced, rare diseases have been met with therapies that target the cause of the condition, enabling the global market for orphan drugs to reach an expected $262bn by 2024.
Biogen agrees Nightstar acquisition for $800m to take on its pipeline of AAV treatments for retinal disorders, diversifyingy its pipeline in the rare disease market.
The market for cell therapy products is set to expand based on increasing investment from the industry and the implementation of advanced manufacturing technologies.
The global cell line development market grows steadily with a predicted revenue of $7.5bn by 2024, each component of the market to see CAGR between 10-15%.
The WHO establishes a multi-disciplinary committee to advise on the ethical and scientific challenges of human genome editing, as the technology’s capability and utilization grows in the industry.
The introduction of the SPC manufacturing waiver will generate billions in export sales and create a number of jobs across the EU, suggests Medicines for Europe.
NICE recommends CAR T-cell treatment Kymirah to be covered by the Cancer Drugs Fund to treat adult patients with lymphoma, despite previous negative appraisals.
Fujifilm Diosynth announces the inception of its FDB center of excellence in bioprocessing 2.0 to extend its bioprocessing innovations with a network of researchers.
