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Emergent is entering into a five-year agreement with Janssen Pharmaceuticals for the large-scale drug substance manufacturing of Johnson & Johnson’s investigational COVID-19 vaccine, Ad26.COV2-S.

The agreement will combine Rentschler’s experience in drug substance manufacturing and Vetter’s expertise in aseptic fill/finish and secondary packaging.

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Intravacc will license CimCure’s iBoost technology, and the companies will jointly develop a COVID-19 vaccine candidate.

While there currently is no molecular therapy targeted against the PAUFgene, Prestige believes its monoclonal antibody has the potential to benefit patients affected by PAUF-positive pancreatic cancer.

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 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.

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

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 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.

FDA is placing emphasis on developing guidance documents more quickly and efficiently, and agency officials expect that such approaches may continue in the future.

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

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

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.

Emer Cooke, currently the director of the Regulation and Prequalification Department at the World Health Organization (WHO) in Geneva, has been nominated by EMA’s management board to be the new executive director of EMA.

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.

The European Medicines Agency’s (EMA’s) Committee for Human and Medicinal Products (CHMP) has recommended Veklury (remdesivir) be granted conditional marketing authorization in the European Union for the treatment of COVID-19.

Biotechnology company, ILC Therapeutics, has revealed that it has entered into a research partnership with the University of St Andrews aimed at progressing a therapeutic drug that can treat COVID-19 to clinical trials.