PharmTech Europe News

A decision by the European Commission on conditional marketing authorization for the European Union’s first COVID-19 vaccine is expected soon.

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

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.

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.

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

Startup company Vivlion has signed a non-exclusive license agreement with ERS Genomics granting access to CRISPR/Cas9 patent portfolio.

New data from CGT Catapult has demonstrated progression by the industry toward commercialization of therapies and an increase in GMP manufacturing space.

Lonza has formed a long-term, strategic collaboration with a global biopharma company for bioconjugation.

Honeywell’s project team has remotely and efficiently migrated Richter Gedeon’s process control system with limited onsite staffing and resources.

Janssen announces rolling submissions for its COVID-19 vaccine with Health Canada and EMA.

eTheRNA Immunotherapies has entered into a strategic cooperation and product license agreement with China Grand Pharmaceutical and Healthcare Holdings to form a new joint venture company, Nanjong AuroRNA Biotech.

MHRA has granted a temporary authorization for emergency use to Pfizer and BioNTech for the mRNA vaccine against COVID-19.

CGT Catapult has launched the Advanced Therapies Skills Training Network, designed to open career opportunities and upskill staff in advanced therapy and vaccine manufacturing in the UK.

The EC’s approval was based on positive results from a Phase III clinical trial that demonstrated a statistically significant and clinically meaningful improvement in patients compared to chemotherapy.

Wacker will support production of CureVac’s COVID-19 mRNA-based vaccine candidate at its biotech site in Amsterdam, with production scheduled to start in the first half of 2021.

A new facility near Frankfurt, Germany expands Avantor's geographic reach and supports the growing demand for scientific research and clinical trial sample storage.

HMA and EMA have released a joint statement on the appropriate route for companies to submit marketing authorization applications and the approval processes for vaccines.

EMA has requested the full data from the Solidarity trial in order to evaluate the marketing authorization of Veklury (remdesivir) in the European Union.

Diurnal Group has been granted a patent for its hydrocortisone granules in capsules for opening, Alkindi, from the European Patent Office.

Watson-Marlow Limited Ireland has revealed plans for a new ISO 14644-1 Class 7 cleanroom to be added to the company’s existing site in Cork, Ireland.

A second global Phase III clinical trial investigating the safety and efficacy of a two-dose regimen of JNJ-78436735 has been initiated by Johnson & Johnson.

CordenPharma has announced the expansion of its non-GMP SPPS manufacturing capacity at its Centre of Excellence for Peptide Process Development and non-GMP manufacturing in Frankfurt, Germany.

Bone Therapeutics has reported the completion of Catalent’s acquisition of Skeletal Cell Therapy Support SA (SCTS)—Bone Therapeutics’ cell therapy manufacturing subsidiary.