Agency IQ
JANUARY 4, 2024
Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. KAROLINE MATHYS is the head of the new sector.
The Pharma Data
SEPTEMBER 7, 2021
0.750% due August 31, 2026. 0.750% due August 31, 2026. 0.750% due August 31, 2026. 0.750% due August 31, 2026. and Citigroup Global Markets Inc. toll-free at +1 (888) 292-0070 or collect at +1 (980) 387-3907 or to Citigroup Global Markets Inc. 3.950% Notes due 2049. 532457 BT4. 1,500,000,000. 532457 AM0.
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Drug Discovery World
SEPTEMBER 6, 2022
Indeed, the growth of the cell and gene therapy market, coupled with the demand that the pandemic placed on manufacturing capacity, means the industry faces shortages of these crucial materials. The challenge for the market then, according to Boissel, is how much can a payor afford to pay upfront? . Workforce .
FDA Law Blog: Biosimilars
DECEMBER 3, 2023
On November 17th, CMS issued its final guidance on the Discount Program in which it responded to public comments and provided updated guidance for the Discount Program for 2025 and 2026. The Discount Program is similar to the CGDP with respect to several requirements and operational processes, and CMS will implement it in a similar manner.
Drug Discovery World
FEBRUARY 26, 2024
For example, Vertex Pharmaceuticals’ stem-cell treatment for sickle-cell disease and transfusion-dependent β-thalassemia was authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) in November 2023, making it the first licensed therapy that uses the gene-editing tool CRISPR to help treat patients.
The Pharma Data
DECEMBER 12, 2020
The success of the franchise is demonstrated by the effective transition of over 70% of PNH patients from Soliris to Ultomiris in less than two years of launch in its key markets, including the US, Japan and Germany , as well as the strong pipeline of additional indications for Ultomiris. 2 EvaluatePharma, World Preview 2020, Outlook to 2026.
The Pharma Data
APRIL 1, 2021
Sanofi expects this new facility to be operational in 2026, following design, construction, testing and qualification of the facility and equipment. The vaccine has received marketing authorizations in 25 countries in Europe (under the name Efluelda ® outside of the UK) for use in adults 60 years of age and older.
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