News

Roche has submitted a marketing authorization application to EMA for Ronapreve (casirivimab/imdevimab) as a treatment for COVID-19.

EMA has halted the rolling review of CureVac's COVID-19 candidate, CVnCoV, due to the company withdrawing from the process.

MHRA has awarded an ‘Innovation Passport’ to CellResearch for its umbilical cord lining stem cell therapy, CorLiCyte.

Pacira’s acquisition grants them access to Flexion’s pain management portfolio.

AstraZeneca reports that its combination antibody therapy, AZD7442, reduced chances of severe COVID-19 or death by as much as 67%.

Supernus will acquire Adamas’ Parkinson's disease treatment portfolio through a $400 million acquisition.

MilliporeSigma, the U.S. and Canadian Life Science business of Merck KGaA, Darmstadt, Germany, signed an agreement with Cellecta to license its genome-editing tool.

The approval of ChemoCentryx’s Tavenos (avacopan) provides a new treatment for active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.

AstraZeneca’s tezelpelumab was granted orphan drug designation by FDA for the treatment of eosinophilic esophagitis.

Pfizer and BioNTech’s request would make them the first vaccine accessible to individuals under the age of 12.

Moderna’s new facility is expected to produce 500 million vaccine doses per year.

FDA’s emergency use authorization will double rapid at-home COVID-19 testing capacity.

The $3 million investment will go towards various projects investigating key product attributes for therapeutic proteins.

The agency received a marketing authorization application a monoclonal antibody treatment for COVID-19 patients.

The agency has concluded that an extra dose of the COVID-19 vaccines may be given to those individuals with severely weakened immune systems.

The agency’s human medicines committee approved an additional site in West Point, Pa. in the United States for the manufacture of Janssen’s COVID-19 vaccine.

New excipients for protein-based drug products reduce viscosity while maintaining protein stability.

Moderna’s new 462,000-ft² science center is expected to be completed by 2023.

The collaboration between Sunovion, Sumitomo Dainippon, and Otsuka will focus on four compounds designed to treat neuropsychiatric health conditions.

Merck and Ridgeback Biotherapeutics' oral antiviral medication reduced the risk of hospitalization or death from COVID-19 by 50% relative to placebo in a Phase III clinical study.

Certara’s acquisition of Pinnacle 21 grants them access to their compliance validation software.

Takeda will use Selecta Bioscience’s ImmTOR platform to develop gene therapies for lysosomal storage disorders.

Thermo Fisher’s new Swiss facility will initially produce CSL Limited’s recombinant factor IX product Idelvion.

The expansion to SGS’s Poitiers facility in France is expected to improve the company’s drug development capabilities.

FDA and EMA are looking to tap real-world data and real-world evidence more broadly to accelerate the research and market approval process.

AstraZeneca’s acquisition of Caelum Biosciences gives them access to CAEL-101, a promising light chain amyloidosis treatment.

Pure Psyence, Pure Extracts and Psyence’s joint venture company, will develop psilocybin-derived treatments.

EMA's CHMP is going to perform an accelerated assessment of data submitted by Moderna regarding the use of a booster dose of Spikevax.