EMA is facing a dilemma in trying to restore activities back to normal after relocating and the COVID-19 pandemic.

COVID-19 vaccines are being developed rapidly, giving rise to a reinvigoration of the sector.

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

FDA Commissioner Hahn commits to a science-based review and approval process.

The COVID-19 pandemic has created a rise in demand for R&D and a shift in focus for some contract organizations.

The company has designed a bioanalytical offering that supports drug development, from in-vitro metabolite identification to human ADME profiling studies.

The new MyMilli-Q gives customers the opportunity to access their laboratory’s water system remotely while supporting online contract management, remote system monitoring and servicing, and data traceability.

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

Bioanalytical studies are a significant part of biologic drug development that may require partnering with bioanalysis experts.

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.