News

MilliporeSigma and Waters will work together to build an extractables and leachables (E&L) reference library.

Taconic Biosciences Cage+ colony management service aims to offer comprehensive coverage for contract breeding services.

Eli Lilly and Company are investing $700 million into a Boston-based facility for the newly announced Institute for Genetic Medicine.

Scottish Enterprise has awarded £20 million (US$27 million) to Valneva Scotland to advance vaccine development.

Alvea has begun preclinical testing of a scalable, shelf-stable DNA vaccine against SARS-CoV-2 variants.

Moderna and Thermo Fisher Scientific have formed a collaboration to leverage dedicated commercial fill/finish manufacturing capacity in the US for mRNA vaccines and therapies.

Sanofi and GSK announce they are seeking regulatory authorization for COVID-19 vaccine.

Novavax announces the first doses of Nuvaxovid COVID-19 vaccine have begun shipping to European Union member states.

The Center for Breakthrough Medicines and BioAnalysis LLC have formed a strategic alliance to offer novel analytical testing services for CGT clients.

Hoffman Neopac has signed a partnership with Saperatec to begin recycling aluminum laminate composites upon its opening in mid-2023.

FDA officials and their scientific advisors have come down hard on clinical development programs that rely on study results from a single foreign country, instead of from multi-regional trials following harmonized R&D standards.

Quotient Sciences announces that it has integrated drug substance into its flagship Translational Pharmaceutics platform.

Recipharm has strengthened its biologics manufacturing capabilities with the acquisition of both Vibalogics and Arranta Bio.

The turnkey facilities will promote scalable vaccine production for an end-to-end manufacturing network for mRNA-based vaccines in Africa.

Health Canada authorizes Novavax COVID-19 vaccine for individuals 18 years of age and older.

PETA Science Consortium International e.V. and PETA scientist Jeffrey Brown share goals with new FDA Commissioner Dr. Robert Califf.

The EC approved AstraZeneca’s Saphenlo (anifrolumab) for the treatment of active autoantibody-positive systemic lupus erythematosus.

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.

The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.

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