Pharmaceutical Technology Editors

The European Medicines Agency (EMA) and the Ministry of Food and Drug Safety of the Republic of Korea (MFDS) have announced an agreement that will enable the parties to share confidential information on COVID-19 medicines.

Industry veteran Loewald tapped to head CDMO Cambrex.

Genomics England (GEL) has announced the launch of a next-generation genomics research platform, supported by Lifebit-a deep tech company-and Amazon Web Services (AWS), which will be primarily dedicated for COVID-19 research.

The European Medicines Agency (EMA) has recommended a conditional marketing authorization be granted for Idefirix (imlinfidase) for the treatment of highly sensitized adult patients waiting for a kidney transplant.

The European Investment Bank (EIB) in partnership with the European Commission (EC) have pledged an additional EUR 4.9 billion (US $5.5 billion) to be used in the global coronavirus response funds.

As a result of disruptions caused by COVID-19, CPhI Worldwide 2020 in-person event will not be taking place in Milan, Italy, but instead will be a unique digital experience to connect the global pharma industry.

Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

Aji Bio-Pharma launched Ajility, a flexible platform for manufacturing vaccines and therapies.

The guidance document provides recommendations regarding data needed for the manufacturing, development, and approval of a COVID-19 vaccine.

The site can now support customized product and bioprocess development and custom cell and gene therapy reagent manufacturing.

The company now offers its CONFIDENCE virus clearance services to support validation of viral clearance processes.

The expansion included adding new softgel encapsulation lines at its Strathroy, Canada and Sorocaba, Brazil sites for Catalent’s Vegicaps plant-based capsule and its CosmoPod twist-off capsule technologies.

Enhanced sensitivity and ultra-high detection speed provide improved robustness and operability.

Pall has introduced a 24-well filter plate that can perform cell clarification and sterilization in one step.

The company has provided updates on its COVID-19 tests under development with Adeptrix and Cytiva, respectively.

The refurbishment provides enhanced glass melting power, improved glass distribution, and the production of transparent and amber type I glass bottles to meet the increase in demand for glass vials for vaccines and life-saving medicines.

Honeywell Forge Cybersecurity Suite’s improved industrial-grade remote access and added protection and risk monitoring aids remote operations.

The expansions included enhancing high-speed automatic syringe assembly and labeling, vial labeling and cartoning, and auto-injector assembly.

The companies are entering into a license agreement to provide CSL Behring with exclusive global rights to etranacogene dezaparvovec, uniQure’s investigational gene therapy for patients with hemophilia B.

The company’s oral COVID-19 vaccine has been chosen to participate in a non-human primate challenge study organized and funded by Operation Warp Speed.

The continuous manufacturing platform can be used for individual unit operations or a complete solid-dosage manufacturing line and can be integrated with third-party equipment.

The partnership combines Malvern’s physicochemical characterization expertise and Concept Life Sciences’ chemistry and analytical services to provide services that focus on analytics, know-how, instrumentation, and expert support to customers.

The updated facility is 60,000 square feet and is equipped with bioprocessing capabilities ranging from 10L to 2000L.

The test results could potentially be used in the development of COVID-19 vaccines and the screening of convalescent plasma for prophylactic and therapeutic use.

Catalent will offer vial filling, packaging capacity, and additional staffing at the site to support the production of the initial 100 million doses of the vaccine candidate to supply the US market beginning in the third quarter of 2020.

The company has expanded its laboratory test portfolio with five new molecular, serology, and functional assays for COVID-19 vaccine and therapy development programs.

Full results from the Phase III ETHOS trial have demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations in patients with moderate to very severe COPD after treatment with triple-combination therapy Breztri Aerosphere.

Symbiosis Pharmaceutical Services has signed a supply agreement with AstraZeneca for the sterile manufacture of AZD1222, a COVID-19 recombinant adenovirus vaccine, to be used in clinical trials.

Novartis UK has issued a statement specifying its disappointment at the initial decision by NICE to not recommend Mayzent (siponimod) for the treatment of secondary progressive multiple sclerosis with active disease.