News

Regulatory officials are addressing challenges in ensuring that clinical data can be relied on in making regulatory decisions.

CytoReason has announced an expanded collaboration deal with Pfizer to deliver AI for drug discovery and development.

Otsuka announced that the EC has approved Lupkynis as the first oral treatment for active lupus nephritis.

Civica is expanding in the greater Richmond-Petersburg region and investing $27.8 million in a new testing facility.

Novo Nordisk and Microsoft are collaborating to accelerate drug discovery and development using big data and artificial intelligence.

Ensysce Biosciences and Quotient Sciences are partnering to develop and test Ensysce’s novel opioid designed to prevent abuse and overdose.

EMA has recommended approval of Enjaymo for the treatment of hemolytic anemia in adult patients with cold agglutinin disease.

The White House hopes to expand US modern biotech manufacturing and reduce reliance on foreign sources of bioindustrial materials.

Emergence Therapeutics will work with Synaffix’s ADC technology platform to develop multiple ADCs against undisclosed targets.

WHO has awarded prequalification to GSK’s Mosquirix, an approved malaria vaccine.

FDA is in jeopardy of losing its fees for assessing and approving new drugs and medical products.

Salipro has been granted patents in the United States and China for its proprietary technology to enable the development of therapeutics against challenging drug targets.

Charles River Laboratories and Cure AP-4 will collaborate on gene therapy manufacturing for AP-4 hereditary spastic paraplegia.

Avance Clinical’s acquisition of C3 Research Associates expands its CRO services to North America.

In partnership with the University of Pittsburgh, ElevateBio will open its next manufacturing center in the city.

Roche’s acquisition of Good Therapeutics grants them rights to the company's conditionally activated PD-1-regulated IL-2 program.

SIRIO is enhancing its strategy for small and medium nutrition brands as Lonza’s Sara Lesina joins as GM in Europe.

Lynparza has been approved in Great Britain as an adjuvant treatment for patients with germline BRCA-mutated HER2-negative high-risk early breast cancer.

Sanofi’s Xenpozyme (olipudase alfa-rpcp) is now the only approved treatment for acid sphingomyelinase deficiency.

Touchlight will expand Lonza’s end-to-end offering for mRNA manufacturing with an additional, differentiated source of DNA raw material.

Hovione has expanded its drug product offering with a new manufacturing line dedicated to continuous tableting.

Novo Nordisk’s $1.1 billion acquisition of Forma Therapeutics is intended to expand its sickle cell and rare blood disorder portfolio.

FDA has issued an emergency use authorization for both the Pfizer-BioNTech and Moderna bivalent COVID-19 boosters.

Bio-Rad’s new antibodies are designed to develop highly selective pharmacokinetic (PK) and anti-drug antibody (ADA) assays for evolocumab and its biosimilars.

Roche’s Digital LightCycler System is designed to aid in diagnostics for cancer, genetic disease, and infection.

Lonza has introduced X-ray powder diffraction capability at its Monteggio, Switzerland site.

Forecyte Bio and Cytiva will team up to accelerate the development and manufacturing of cell and gene therapies.

Emerson’s new gas analysis solutions center, located in Cumbernauld, Scotland, intends to help plants meet sustainability goals.