Pharmaceutical Technology Editors

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’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.

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

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.

The test developed by Luas Diagnostics and Bond Digital uses a smartphone app to enhance a 15-minute COVID-19 immunity test.

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.

Vaccine access campaigners have projected a request to waive vaccine patents onto the hotel where the annual conservative party conference is being held.

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.

DRI’s subsidiary has acquired a royalty interest in Oracea (doxycycline) for $46.4 million.

Appili Therapeutics and AiPharma Global Holdings announced a strategic alliance to advance the global development of a broad-spectrum antiviral treatment in oral tablet form for the treatment of COVID-19.

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.

Merck’s 11.5 billion acquisition of Acceleron gives them access to their lead therapeutic candidate, sotatercept.

Rengeron’s trial found that REGEN-COV significantly reduced viral load of patients with COVID-19.

Novartis and Medicines for Malaria Venture have reported positive results from the Phase IIb study, evaluating a new non-artemisinin combination to treat uncomplicated malaria in children.

ViiV Healthcare has presented three-year clinical trial, reinforcing that the two-drug regimen Dovato can be used as a viable switch option for people living with HIV.

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

EMA is providing support via its Innovation Task Force (ITF) for developers to help them reduce, replace, and refine animal use in drug development.

In September, Codex DNA released a full-length synthetic genome for the SARS-CoV-2 delta variant, which may accelerate discovery and development of diagnostics and treatments for COVID-19.

The new LabVantage Enterprise SaaS adds full configurability and custom interfacing capabilities.

NewAge Industries has completed a plant expansion that added new cleanrooms to its headquarters in Southampton, Pa.

Gyros’ new titer kit identifies adeno-associated virus serotype 9 in vector-based cell and gene therapy manufacturing.

FDA granted orphan drug designation to Catalyst Biosciences’ MarzAA for the treatment of Factor VII Deficiency.