News

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

As Brexit talks intensify, bio/pharma companies from both the UK and EU need to consider and aim to prepare for all scenarios.

The new Uhlmann bottle line uses Cremer technology for 100% counting accuracy and an inspection and rejection system for all critical quality parameters.

The new Uhlmann bottle line uses Cremer technology for 100% counting accuracy and an inspection and rejection system for all critical quality parameters.

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.

EMA’s Committee for Human Medicinal Products (CHMP) has recommended that Kaftrio, a triple combination therapy for the treatment of cystic fibrosis, be authorized for marketing in the European Union.

Vertex Pharmaceuticals has announced that it has extended its agreement with the National Health Service (NHS) England for its cystic fibrosis medicines.

Cambrex has invested in an expansion of its flexible manufacturing facility in Sweden, which will increase the company’s flexible drug substance manufacturing capacity.

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.

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.