Drug Development

FDA issued approvals for less than half the number of new drugs in 2016 compared with 2015.

The £14-million research project aims to better understand adverse drug reactions through a variety of modeling approaches.

In a recent deal with the Federal Trade Commission, Endo agreed to refrain from entering into future pay-for-delay agreements for ten years.

Merck will pay a one-time fee of $625 million and additional royalties to BMS and Ono Pharmaceutical to settle the patent infringement case related to Keytruda.

New website allows access to research quantities of commercial-grade ligands and catalysts.

The partnership will focus on providing practical information to clients on the development of biologics and vaccines.

GEA’s ConsiGma continuous tableting line combined with Siemens’ automation and Sipat data management systems enables continuous manufacturing.

Alternatives to expensive palladium catalysts are gaining acceptance for commercial API synthesis.

As of mid-December, less than half the number of new drug approvals were issued by FDA in 2016 compared with 2015.

As pharmaceutical quality metrics evolve, they will need to incorporate more of the principles of operational excellence, says consultant Prabir Basu.

Isothermal titration calorimetry and differential scanning calorimetry are valuable tools that can help accelerate drug development.

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

A pilot project, beginning in 2017, will support the development of biosimilars.

The companies entered a manufacturing agreement for the future commercial production of Lenti-D and LentiGlobin product candidates.

Oxford Genetics received £1.61 million from Innovate UK to explore computational and synthetic biology approaches for optimized mammalian bioproduction.

Saneca Pharma has received a EUR1.5 million grant from the Slovak Ministry of Education, Science, Research, and Sport, which will be used to drive forward new R&D initiatives for API manufacturing.

Previous hesitation by pharma industry to use cocrystals may change with FDA’s new guidance that classifies cocrystals APIs.

Researchers test the efficacy of a new polymer that is an alternative to PEG for drugs used to treat type 2 diabetes.

FDA and BARDA awarded a contract to Continuus Pharmaceuticals to develop an end-to-end continuous manufacturing process for solid-dosage drugs.

Quantitative and qualitative tools allow better understanding of mixing in a single-use bioprocessing system.

Non-precious-metal catalysts are increasingly employed for commercial API synthesis.

Catalent adds two softgel facilities and packaging capabilities with acquisition of Canada-based Accucaps.

Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.

Oxford Genetics has been awarded a grant to develop packaging cell lines for virus bioproduction and will work in collaboration with the University of Oxford to generate cell lines for the scalable manufacture of retrovirus and lentivirus vectors.

The half-cycle method for validating sterilization can have adverse effects on materials if used for steam sterilization.

Ensuring that materials have optimal critical quality attributes for the required formulations is crucial.

British artificial intelligence company BenevolentAI has signed an exclusive license for a series of novel clinical-stage drug candidates with Johnson & Johnson.

Envigo’s new assessment program can help identify if a drug has possible risk factors associated with hepatotoxicity.

The study in 48 healthy adults will assess the safety and immunogenicity of a prime-boost regime of two different intranasal doses of the RSV vaccine, SynGem.