Pharmaceutical Technology Editors

The HERALD trial will involve participants 18 years and older who will receive a two-dose schedule of CVnCoV or placebo at multiple sites is Europe and Latin America.

The companies are entering into a license and collaboration agreement for the development and commercialization of Relay’s investigational cancer treatment, RLY-1971, a potent inhibitor of SHP2, a molecule that plays a role in cancer cell survival.

The ISPE APQ Guide: Corrective Action and Preventive Action (CAPA) System is the first in a four-part series that will address refining pharmaceutical quality and guaranteeing sustainable compliance within organizations.

The company will expand its clinical supply chain services by establishing two new facilities in Rheinfelden and Weil am Rhein, Germany.

Through the acquisition, Eli Lilly will have access to Prevail’s portfolio of clinical-stage and preclinical neuroscience assets.

Trixeo Aerosphere—AstraZeneca’s triple-combination COPD therapy—has been approved for use in the European Union (EU).

Sterling Pharma Solutions has formed a new strategic partnership with ADC Bio.

A report, launched by Takeda UK, has shown that despite the increase in media attention, COVID-19 has had little positive impact on the perception of pharmaceutical companies.

EUA marks a milestone in COVID-19 vaccine development and is hailed as a turning point in pandemic fight.

The company will expand the site to include six new containment isolators and a product development manufacturing laboratory.

Through the acquisition, AstraZeneca will work with Alexion’s R&D team to build up Alexion's pipeline of 11 molecules across more than 20 clinical-development programs in several indications.

Through the acquisition Gilead will gain access to Hepcludex (bulevirtide) for the treatment of chronic HDV infection in adults with compensated liver disease.

Committee recommends Emergency Use Authorization of first mRNA-based COVID-19 vaccine; FDA approval is pending.

ISPE and Gilead Sciences have partnered up for the establishment of an internship program.

The European Commission has granted a license for the use of inclisiran (Leqvio) as a treatment of primary hypercholesterolemia or mixed dyslipidaemia in adult patients.

Celltrion Healthcare has announced that EMA's CHMP has issued a positive opinion for the marketing authorization of CT-P17—an adalimumab biosimilar.

The Vaccines Manufacturing and Innovation Centre (VMIC) has chosen Lonza’s MODA-EM solution for the digitalization of its microbiology quality control operations.

The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint strategy for medicines regulation in Europe over the next five years.

With the acquisition, Evonik will expand its life science division and its portfolio of functional excipients and biomaterials.

Evonik offers lipid nanoparticles for gene-based drug development and manufacturing.

The European Medicines Agency has launched a full investigation into a cyberattack.

The company is investing in expansion at four sites in the United States, United Kingdom, and Italy, which will include construction of new facilities and addition of sterile and lyophilized filling lines.

The collaboration includes the development, commercialization, and supply of Orgenesis’ pipeline in South Korea and Japan and the development and commercialization of Cure Therapeutics’ pipeline on a global basis.

Through the acquisition, PTI will gain access to LDA’s lead product, the SIMS 1915+, a helium leak test system that combines its helium leak detection technology with its SIMS software for data collection and analysis.

The company has received $500 million in funding from Sino Biopharmaceutical for further development, capacity expansion, and manufacturing of CoronaVac, its COVID-19 vaccine candidate.

CDMO HALIX will manufacture the drug substance for AstraZeneca’s COVID-19 vaccine candidate, AZD1222, at commercial scale at its cGMP facility in the Netherlands.

Dr. Marcus Michel will take over the role from Richard Stedman, who has served as CEO for the past three years, as he transitions to a special advisor role for the company.

The company will expand its micronization abilities for highly potent drug compounds through this investment.

Pfizer-BioNTech details its case for Emergency Use Authorization for "highly effective" COVID-19 vaccine.

The product is being recalled because of Burkholderia cepecia contamination.