Industry News

Data showed that the drug candidate activated T regulatory cells, believed to serve a crucial role in protecting the body from uncontrolled inflammation or autoimmunity.

The companies agreed to a multi-year research and development collaboration that will focus on AI empowerment and exploration.

Researchers used advanced animal model lab tests to determine the new vector is 10 times more efficient at incorporating corrective genes into bone marrow stem cells than traditional vectors.

The agency seeks comments on a draft guidance designed to make the process conform to its original intent as a communication tool, rather than a roadblock to competition and innovation.

The project will focus on the development of an influenza vaccine that protects against multiple strains of the influenza virus in a single dose.

After months of planning and explaining, Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), finally gained approval for broad changes in its process and procedures for evaluating and approving new drugs.

A new educational platform by Quality Executive Partners offers on-demand digital courses with technical content, virtual reality, and real-time coaching with an initial focus on sterile product manufacturing and microbiology.

The project focused on accelerating the discovery and development of monoclonal antibodies and aimed to tackle the limitations in the biologics supply chain.

The new board will assume their positions at the 2019 ISPE Annual Meeting & Expo on Oct. 27–30, 2019 in Las Vegas, NV.

In parallel to the priority review designation for its biologics license application, Merck plans to scale up its doses of the investigational Ebola vaccine to meet global outbreak response needs.

The merger creates a combined organization with a leading position in the eClinical market.

The companies aim to integrate glucose sensing with insulin delivery technologies to help change the way diabetes is managed.

FDA approved the drug after a successful open-label study of children aged six to 11 years and living with the condition.

Time is running out on Ned Sharpless’ term as FDA acting commissioner, generating much talk as the administration shows interest in naming a new head for the agency.

The companies plan to create a new curriculum focusing on single-use applications training, cell therapy technology, process efficiency strategies, process development methodologies, and chromatography proficiency.

FDA issued a statement about the importance of reporting adverse events resulting from the use of compounded drugs.

FDA announced it is developing a series of guidance documents to promote methodological patient-focused drug development.

FDA sent a warning letter to Stemell, Inc. for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice and current good manufacturing practices.

A US District Court judge in Tennessee entered a consent decree of permanent injunction against Basic Reset and Biogenyx after multiple FDA inspections of the companies’ facility found violations of the Federal Food, Drug, and Cosmetic Act.

A new report by GlobalData projects 2.9% growth by 2028 for the hemophilia A and B market across the eight major world markets.

JW Pharmaceutical Corp will acquire the rights to 100% of the shares of Euvipharm along with a state-of-the-art pharmaceutical plant located in Vietnam.

The multitude of health reform measures emerging on Capitol Hill has accelerated lobbying action across the board, along with campaign donations to candidates from all sides.

The awards recognize are judged on innovation, purpose and benefits to the audience, problem-solving, and competitive advantage.

Medical researchers from the Centenary Institute and the University of Sydney in Australia have managed to successfully develop and test a new vaccine targeting tuberculosis.

BioCity has revealed it will be investing in Kinomica, an early-stage precision medicine biotech company that was spun out of Barts Cancer Institute, Queen Mary University of London.

While downgrading the impact of nitrosamine impurities on patients, FDA vows to step up investigations for other drug types.

The partners will collaborate to identify the bioactive components in hydrolysates, which have long been used as additives in cell culture media and feed formulation in the biopharma industry.

A ruling in Oklahoma that Johnson & Johnson’s marketing efforts created a public nuisance may establish a precedent of other jurisdictions.

The new vaccine will offer protection against the Nipah virus after a single dose.

Innovate UK has awarded a grant worth thousands to the Atelerix Consortium for the collaborative work with the Cell and Gene Therapy Catapult and Rexgenero on development of cell stabilization technology.