Fujifilm is expanding its R&D footprint at its California facility.

Baxter will invest $100 million in new lyophilization equipment and an additional aseptic syringe filling line at its Halle/Westfalen (Germany) location.

Sotera’s acquisition of Regulatory Compliance Associates (RCA) will expand its technical consulting services.

AbbVie will pay REGENXBIO up to $1.75 billion for the rights to develop and commercialize its treatment of various eye conditions.

European Medicines Agency (EMA) granted Rafael’s CPI-613 (devismat) an orphan drug designation for the treatment of refractory or relapsed Burkin’s lymphoma.

The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.

Hovione will invest $170 million in new capacity and capabilities in Portugal, Ireland, and New Jersey

The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.

The winners of the 18th CPhI Pharma Awards, which are given as a recognition of ‘Excellence in Pharma’, were announced on November 9, 2021, in Milan.

Flagship Pioneering has officially launched Alltrna, a company planning to combat genetic diseases with transfer ribonucleic acid (tRNA) medicine.

The agreement will allow Birmingham Biotech to commercialize the University of Birmingham’s antiviral COVID-19 nasal spray.

EPRONTIA (topiramate) oral solution, 25 mg/mL has been approved to treat certain seizures in patients two years of age or older and for use to prevent migraine in patients 12 years of age and older.

The agency is reviewing data on the use of molnupiravir (MK 4482 or Lagevrio) for potential use to treat COVID-19 prior to authorization.

Pfizer’s investigational oral antiviral COVID-19 candidate reduced COVID-19-related hospitalization or death by 89% in patients who received it within three days of symptom onset.

Element’s acquisition of JMI Laboratories will increase their North American service offerings.

Part 1—Industry experts from MilliporeSigma, Lonza, Astrea Bioseparations, and Sartorius discuss key issues affecting the development of emerging biotherapies.

The agency found Lagevrio (molnupiravir) to be safe and effective at reducing the risk of death and hospitalization for those with mild to moderate COVID-19 infections.

EMA has ended rolling review of bamlanivimab and etesevimab COVID-19 antibody treatments after Eli Lilly Netherlands BV withdraws from the review process.

The partnership between Waters and Sartorius aims to accelerate speed and increase accuracy in bioprocessing analysis.

TCR² Therapeutics will add a second clean room to their manufacturing operations.

GenScript’s new gene synthesis center in Piscataway, NJ, is highly automated to accelerate production time and increase supply chain resiliency for biopharma and synthetic biology.

Gentronix has expanded it lab facilities and increased capacity for genetic, ocular, and skin toxicology testing.

Thermo Fisher Scientific showcases its new mass spectrometry and chromatography solutions at the ASMS Conference on Oct. 31–Nov. 4, 2021.

Democratic leaders in the House and Senate appear to have reached a compromise on a relatively modest plan for controlling prices on certain prescription drugs.

Lonza is expanding its exosomes development and manufacturing capabilities with the acquisition of a service unit from Exosomics and a manufacturing facility from Codiak BioSciences.

Novavax and Serum Institute of India’s COVID-19 vaccine, Covavax, received an Emergency Use Authorization from the Indonesian government.

The researchers will use 3D printing to design novel flow reactors and static mixers.

Janssen Sciences Ireland was honored for its project execution of a large-scale expansion of biologics drug substance fed-batch capacity.