News

The company has announced plans to establish a commercial presence in six European countries.

FDA will hold a symposium discussing the identification of concepts and terminology for multi-component biomarkers from March 23–24, 2022.

The commercialization and licensing deal will see Biogen commercialize Xbrane’s Xcimzane, a proposed biosimilar for CIMZIA (certolizumab pegol).

Thermo Fisher Scientific is expanding its Millersburg, Penn., site with a $40 million investment to support increased production of single-use technology for critical vaccines and biologics.

ONK will receive non-exclusive rights to Intellia’s proprietary ex-vivo CRISPR/Cas9 technology in the development of five allogeneic NK cell therapies.

ImmunoGen and Eli Lilly and Company have entered into an agreement that gives Lilly exclusive rights to research, develop, and commercialize ADCs designed for targets selected by Lilly from ImmunoGen’s camptothecin technology.

FDA has granted Eli Lilly and Company’s bebtelovimab, a monoclonal antibody designed for treatment of COVID-19, an Emergency Use Authorization (EUA).

The deal between ProBioGen and AstraZeneca will allow AstraZeneca to use ProBioGen’s GlymaxX technology.

The agency recommended 53 new active substances in 2021, up 35% from 2020.

Guidance published during the pandemic has been updated to include content requirements for summary safety reports.

Thermo Fisher Scientific's solution for cell and gene therapies involves a combination of cold chain logistics, serialization compliance, and distribution

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

Novavax’s COVID-19 vaccine has received conditional marketing authorization from MHRA and provisional approval from Medsafe.

EMA has started its evaluation of an application for the use of a booster dose of Comirnaty in adolescents aged 12–15 years.

EMA has started the establishment of its Data Analysis and Real World Interrogation Network (DARWIN EU) Coordination Centre.

In an agreement with MaaT Pharma, Skyepharma will build MaaT a dedicated 1500-m² microbiome ecosystem therapies manufacturing site.

FDA has approved sutimlimab-jome as a treatment for hemolysis in individuals with CAD.

Sartorius Stedim Biotech has completed the acquisition of the chromatography equipment division of Novasep.

The European Patent Office has granted another patent to Salipro Biotech, covering the composition-of-matter, methods, and uses of the company’s novel antigen technology.

CGT Catapult has partnered with MICA Biosystems to advance MICA’s regenerative medicine technology to the UK’s MHRA.

With new COVID-19 infections declining, the agency is resuming domestic inspections of drug manufacturing facilities.

Bio-Rad’s four new antibodies will develop highly selective and sensitive assays for bioanalysis and drug monitoring of pertuzumab and its biosimilars.

Gandeeva raisded $40 million to advance its AI-driven cryo-EM platform, with which it will develop new therapeutics based on the precise imaging of protein–drug interactions.

The agency approved Roche’s Vabysmo to treat neovascular or “wet” age-related macular degeneration and diabetic macular edema.

The acquisition will include Rewrite’s DNA writing platform, expanding Intellia’s genome editing tools.

A range of political issues have impacted FDA initiatives vital to the agency’s effectiveness and stature, both at home and on the important global stage.

Janssen has submitted a MAA to the EMA for teclistamab as a treatment of relapsed or refractory multiple myeloma (RRMM).

Eli Lilly and Company is investing $1 billion to establish a new manufacturing stie in Concord, N.C., to manufacture parenteral products and devices.