News

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.

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

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.

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.

FDA approved AbbVie’s Qulipta (atogepant) as a preventative migraine treatment.

USP is publishing the analytics-focused chapter, which considers validation activities, in advance of the official publication.

CuriRx’s CuriLytics platform is a mass spectrometry instrument that will support complex biotherapeutics development.

GeneTx Biotherapeutics and Ultragenyx Pharmaceutical announced that FDA has removed the clinical hold on GTX-102, an investigational treatment for Angelman syndrome.

According to Charles River Laboratories, when asked how long it takes for a drug to be developed and approved for market in the United States, only 10% of 1,500 Americans polled correctly estimated that it takes between 10 and 15 years.

The lack of a new permanent commissioner has hampered FDA in articulating future priorities and pushing back against miscommunications and outside complaints.

Biosimilar approvals and the advance of biosimilar testing and production may lead to greater access to alternative therapies.

Researchers in China report test results for a microneedle patch for COVID-19 vaccine delivery.

Biden outlines a plan to end the pandemic in a virtual global conference.

The first and only approved antibody-drug conjugate for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy receives accelerated approval by FDA.

Boehringer Ingelheim to develop novel cancer therapies by leveraging Abexxa’s breakthrough antibody-based drugs.