Articles

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

Intellia and ONK Therapeutics Enter Gene-Editing Partnership

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.

ImmunoGen Grants Lilly Exclusive Research, Development, and Commercialization License in $1.7+ Billion ADC Deal

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

FDA Grants Eli Lilly Drug EUA for Treatment of COVID-19 

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

ProBioGen Inks License Agreement Deal with AstraZeneca

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

EMA Updates Guidance on Risk Management Plans for COVID-19 Vaccines

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

EMA Investigating Reports of Menstrual Irregularities with COVID-19 Vaccines

The agency’s safety committee is reviewing the use of Janus kinase inhibitors to treat inflammatory disorders because of the potential for major cardiovascular problems.

EMA Reviews Safety of Janus Kinase Inhibitors to Treat Inflammatory Disorders

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

New Medicines Recommendations Up in 2021, EMA States

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

Thermo Fisher Scientific Unveils New CGT Services

Stephan Hütter is associate director, Global Program Management at PharmaLex.

While companies today outsource numerous processes, from early development through to manufacturing, there are still many opportunities to realize the full potential of outsourcing services.

News