The new SDMS automatically gathers and protects all instrument and other laboratory data as it is generated for enhanced lab management, quality, and security.

FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.

CordenPharma added a 3000-L solid-phase peptide synthesis vessel to its GMP API facility in Boulder, CO.

VAR2 Pharmaceuticals has been selected for its development of a drug-conjugated malaria protein that potentially selectively binds to most human tumor types.

BARDA and DOD have awarded a $450-million contract to Regeneron Pharmaceuticals to manufacture and supply an investigational double antibody cocktail in development for treating COVID-19.

The acquisition will give the CDMO additional clinical filling options in Europe, which is expected to come online in 2021.

The company will manufacture a conjugated vaccine candidate being developed to prevent the disease melloidosis.

The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union.

SGS has announced the receipt of approval from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) to begin a new clinical trial of a potential treatment for patients with COVID-19 related respiratory failure.

The new site will offer initial design and development, low-volume manufacturing, and scalable high-quality production of wearable drug delivery devices.

The agreement will fund the late-stage clinical development, a Phase III clinical trial, large-scale manufacturing, and the delivery of 100 million doses of Novavax’s COVID-19 vaccine candidate, NVX‑CoV2373.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

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

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.

Lonza is making additional investments in its global particle engineering network for expanded capacity and specialized capabilities.

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.

There is much to learn from the COVID-19 pandemic, but future success may hinge upon the capacity for regulatory bodies to harmonize approaches.

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.