Industry News

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.

ABPI has issued a statement of support in response to the United Kingdom’s Prime Minister’s recent order of urgent action to boost the numbers of children receiving vaccinations.

A biosimilar to Eli Lilly’s Forsteo, biosimilar teriparatide, has been launched across Europe by Gedeon Richter following the patent expiration of the reference product.

FDA sent a warning letter to NingBo Huize Commodity Co. after an investigation of the company’s Zhejiang facility found falsified quality documents.

Olympus will launch its first Global Image of the Year Life Science Light Microscopy Award to recognize life science imaging.

The partnership aims to establish a virtual R&D center to advance the development of new cancer therapies.

FDA sent a warning letter to Emcure Pharmaceuticals, Ltd. because of sterility testing CGMP violations.

The European Commission has approved an extension of the use of Dupixent (dupilumab) within the EU to include patients aged 12 to 17 years old with moderate-to-severe atopic dermatitis.

Industry has responded favorably to the recent announcement from the UK's PM that immigration rules should be developed to ensure scientific talent is attracted to the country.

The agency is planning to clean out its drug listing records and urges companies to update any inaccurate active drug listing submission.

Spectrum Laboratory Products received an FDA warning letter after violations were found at its New Brunswick, NJ facility.