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BioWorld - Wednesday, November 12, 2025
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Is Brazil moving toward a med-tech price cap?

Sep. 24, 2019
By Sergio Held
BOGOTA, Colombia – Last month, Anvisa, Brazil's health surveillance agency, approved a proposal that makes it mandatory for the agency to monitor the prices of medical implants, a category that, in Brazil, includes orthoses, prostheses and special materials. Is this the beginning of a price capping era for medical devices in the Latin American giant?
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Regulatory front

Sep. 24, 2019

Crysvita approved in Japan for FGF-23-related hypophosphatemic rickets and osteomalacia

Sep. 23, 2019

Regulatory front

Sep. 23, 2019

Product regulatory actions for Sept. 20, 2019

Sep. 23, 2019

Biotech companies lead big pharma in new medicine approvals

Sep. 23, 2019
By Peter Winter
The recent FDA approval of Ibsrela (tenapanor), Ardelyx Inc.’s treatment for irritable bowel syndrome with constipation in adults, brings, according to the agency’s data, the number of new molecular entities (NMEs) to 27 this year. With just three months remaining, it appears that the biopharma sector is on pace with the five-year average of about 43 NMEs approved annually. 
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Lasvic approved in Japan to treat respiratory and ENT infections

Sep. 20, 2019

FDA resets performance guidance along with four product-specific guidances

Sep. 20, 2019
By Mark McCarty

Regulatory front

Sep. 19, 2019

Product regulatory actions for Sept. 18, 2019

Sep. 19, 2019
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