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Results For "regulatory-approval"

316 News Found

Thermo Fisher Scientific to acquire CorEvitas for $912.5 million
News | July 10, 2023

Thermo Fisher Scientific to acquire CorEvitas for $912.5 million

Advances clinical research capabilities with leading regulatory grade registries platform


Syngene to acquire multi-modal facility from Stelis Biopharma
News | July 05, 2023

Syngene to acquire multi-modal facility from Stelis Biopharma

Adding 20,000 liters of installed biologics drug substance manufacturing capacity


Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir
News | June 27, 2023

Seven manufacturers sign sublicence agreements with the MPP to produce generic versions of Shionogi's COVID-19 oral antiviral ensitrelvir

Ensitrelvir is an oral antiviral that suppresses the replication of SARS-CoV-2 by selectively inhibiting the viral 3CL protease.


Nouryon launches new high-efficiency spherical silica for peptide-based pharmaceuticals
News | June 21, 2023

Nouryon launches new high-efficiency spherical silica for peptide-based pharmaceuticals

This patent-pending, high-efficiency chromatography media is used for the purification of novel peptide-based pharmaceuticals in the GLP-1 agonist class including type 2 diabetes and obesity treatments


Novartis to acquire Chinook Therapeutics for US$ 3.2 bn
News | June 12, 2023

Novartis to acquire Chinook Therapeutics for US$ 3.2 bn

Chinook Therapeutics is a clinical-stage biopharmaceutical company with two high-value, late-stage assets in development for IgA nephropathy (IgAN), a rare, progressive chronic kidney disease


Capnopharm receives CE certification for its new CapnoPen technology
News | May 31, 2023

Capnopharm receives CE certification for its new CapnoPen technology

Capnopharm’s new CapnoPen is the first PIPAC nebulizer to obtain CE marking under the new MDR regulation 2017/745


Lonza launches TheraPEAK T-VIVO cell culture medium to accelerate cell therapy development
News | May 24, 2023

Lonza launches TheraPEAK T-VIVO cell culture medium to accelerate cell therapy development

Lonza launches the TheraPEAK T-VIVO Cell Culture Medium with a novel chemically defined formulation developed to optimize and streamline CAR T-cell manufacturing


Baxter  to sell its BioPharma Solutions Business to Advent International and Warburg Pincus for US $4.25billion
News | May 09, 2023

Baxter to sell its BioPharma Solutions Business to Advent International and Warburg Pincus for US $4.25billion

Proposed divestiture of BioPharma Solutions (BPS) further streamlines Baxter’s strategic focus and represents an important milestone in its ongoing business transformation


Biocon approves NCD issue
News | April 27, 2023

Biocon approves NCD issue

The return profile of NCDs is linked to BBL share price subject to minimum IRR of 12%.