FDA announced it is developing a series of guidance documents to promote methodological patient-focused drug development.
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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.
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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.
Sponsors should seek early discussions with FDA to ensure an effective and efficient process for demonstrating the interchangeability of a chosen biologic product.
South Korea’s pharma/biotech space is projected to grow to $23.2 billion by 2022, and will likely attract foreign investment, according to a new market report by GlobalData.
The guidance answers questions about how the agency awards priority review vouchers to sponsors of treatments for rare pediatric diseases.
The guidance discusses clinical trial design features that can support approval of treatments of Fabry disease.
The agency is keeping Zolgensma on the market as it evaluates the accuracy of data submitted with the product’s biologics license application.
Successful process intensification with inline dilution requires effective monitoring and control.
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